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| ID | Type | Description | Link |
|---|---|---|---|
| 30070 | Registry Identifier | DAIDS-ES Registry Number |
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| Name | Class |
|---|---|
| ViiV Healthcare | INDUSTRY |
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The purpose of this study was to determine the dosage for oral cabotegravir (CAB) and long-acting cabotegravir (CAB LA) and long-acting rilpiverine (RPV LA) and evaluate the safety, acceptability, tolerability, and pharmacokinetics (PK) of oral CAB, CAB LA, and RPV LA in virologically suppressed children and adolescents living with HIV.
IMPAACT 2017 was a Phase I/II, multi-center, open-label, non-comparative dose-finding study with the primary objective of evaluating the safety, acceptability, tolerability, and PK of oral cabotegravir (CAB) and long-acting cabotegravir (CAB LA) as well as long-acting rilpivirine (RPV LA) in adolescents living with HIV-1, who are 12 to <18 years of age, ≥35kg, and virologically suppressed.
The study design included two cohorts of participants and five study steps. In Cohort 1, Step 1 participants received either oral CAB or oral rilpivirine (RPV) for at least four weeks and up to six weeks (maximum). In Cohort 1, Step 2 participants received intramuscular injectable formulations of the study products, either CAB LA or RPV LA. Cohort 1 participants were assigned either CAB (Cohort 1C) or RPV (Cohort 1R) based on their pre-study combination Antiretroviral Therapy (cART) regimen. Participants on a PI-based and/or NNRTI-based cART regimen were assigned to Cohort 1C, and participants on a non-boosted INSTI-based cART regimen were assigned to Cohort 1R. All participants continued their pre-study cART regimen during Cohort 1.
During Cohort 2, all participants discontinued their pre-study cART regimen and received both study products, CAB and RPV, at the doses established in Cohort 1. Cohort 2 participants enrolled to either Cohort 2A to receive both oral CAB + oral RPV (Step 3) followed by both CAB LA + RPV LA (Step 4) or Cohort 2B to directly receive both CAB LA + RPV LA without an oral lead-in phase (Step 5). If eligible, Cohort 1 participants were able to enroll into Cohort 2 (i.e., Cohort 1 Rollover). However, Cohort 2 participants who were not previously enrolled in Cohort 1 (i.e., Cohort 1-Naïve) were the primary group for analyses and conclusions. No participants enrolled into Cohort 2B, direct to injection (Step 5). Therefore, all references to Cohort 2 refer to Cohort 2A (Steps 3 and 4).
Two interim analyses were planned. The first interim analysis established the doses for Cohort 2 and determined whether to open Cohort 2 to Cohort 1 participants who met criteria to enter Cohort 2. The second interim analysis provided justification to open Cohort 2 to additional participants who were not previously enrolled in Cohort 1. A final analysis of Cohort 1 data was performed to confirm the final doses for Cohort 2.
Safety and PK evaluations were performed during Steps 1-5 and long-term safety follow-up (LSFU). Antiviral activity assessments were performed during Steps 1-5. Acceptability and tolerability were assessed during Steps 1-5 and LSFU, with all participants completing quantitative questionnaires and a subset of participants completing in-depth qualitative interviews. Additionally, parents/caregivers of a subset of U.S. participants from U.S. sites were also enrolled to complete a single in-depth qualitative interview. Because objectives related to parents/caregivers were exploratory, these outcomes are not described here.
Cohort 1 participants were followed for up to 64 weeks. Participants were followed for at least four weeks in Step 1 (oral phase) and at least 12 weeks in Step 2 (injection phase). All Step 2 participants were followed (on cART, off study product) for up to an additional 48 weeks as part of LSFU after their last study product injection. If eligible, Cohort 1 participants enrolled into Cohort 2 before completing LSFU. For Cohort 1, Step 1 participants not progressing to Step 2, the last visit was targeted to be completed 28 days after the participant's last oral study product use.
Cohort 2 participants were followed for up to 188 (Cohort 2B) or 192 (Cohort 2A) weeks. Participants were followed for at least four weeks in Step 3 (oral phase) and 92 weeks in Step 4/Step 5 (injection phase). After completing 92 weeks of follow-up in Step 4/Step 5 (injection phase), Cohort 2 participants who continued access to injectable study products through a mechanism external to the protocol exited the study. If it was not possible for participants to access injections of CAB LA + RPV LA from non-study sources at the completion of their Step 4 Week 96 or Step 5 Week 92 visit, participants remained in the study safety extension for up to 48 weeks. Participants who permanently discontinued injectable study product use during Cohort 2, Step 4/Step 5, or did not wish to continue to access the study products through the external mechanism after their Week 96 visit, were followed (on cART, off study product) for an additional 48 weeks as part of LSFU after their last study product injection, except for participants in the study safety extension. Participants in the study safety extension who decided to permanently discontinue injectable study product or who had not established access to study product after the 48 weeks in the study safety extension would exit the study (not enter LSFU). For Cohort 2, Step 3 participants not progressing to the injection phase, the last visit was targeted to be completed 28 days after the participant's last oral study product use. Female participants who discontinued study product use (either oral or injectable study product) due to pregnancy during Steps 1-5 were followed for an additional 48 weeks in LSFU to assess long-term safety and washout PK of the study products, except for participants in the study safety extension. Participants who became pregnant during the safety extension were only followed until the pregnancy outcome was determined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1C: CAB | Experimental | Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks. Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12). Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8). |
|
| Cohort 1R: RPV | Experimental | Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks. Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12). Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8). |
|
| Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA | Experimental | Step 3: CAB administered orally as one 30 mg tablet once daily and RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit for 4-6 weeks. Step 4: First and second injections: CAB LA administered as a 600 mg IM injection and RPV LA administered as a 900 mg IM injection at Week 4b and at Week 8. Subsequent injections: starting at Week 16, CAB LA administered as a 600 mg IM injection and RPV LA administered as a 900 mg IM injection every eight weeks through Week 96 or final safety extension visit. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Cabotegravir (CAB) | Drug | 30 mg tablets administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Who Had Grade 3 or Higher Adverse Event (Cohort 1) | Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an AE severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI). | Cohort 1 Treatment Initiation through Week 4 |
| Proportion of Participants Who Had Grade 3 or Higher Adverse Events Assessed as Related to Study Product/s (Cohort 1) | Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an AE severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE assessed as related by the site investigator of record to study product through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI). | Cohort 1 Treatment Initiation through Week 4 |
| Proportion of Participants Who Had Serious Adverse Events Meeting International Conference on Harmonisation (ICH) Criteria Assessed as Related to Study Product/s (Cohort 1) | Adverse events (AE) were assessed as a Serious AE by ICH criteria. Per ICH, a serious AE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect (see references for additional details). We present the proportion of participants with at least one serious AE assessed as related to study product by the site investigator of record through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI). |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With HIV-1 RNA < 50 Copies/mL (Cohort 1) | We present the proportion of participants with results of HIV-1 RNA < 50 copies/mL at Week 16 | Week 16 |
| Proportion of Participants Who Reported "Hurts Whole Lot" or "Hurts Worst" in Regards to Being Bothered by Pain During Injection of CAB LA or RPV LA (Cohort 1) |
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Inclusion Criteria: Cohort 1 Step 1, Cohort 2 Step 3, and Cohort 2 Step 5
All the following criteria must be met for inclusion of any adolescent participant in Step 1 of Cohort 1, or in Step 3 of Cohort 2, unless otherwise noted:
At enrollment, body weight greater than or equal to 35 kg (77 lbs)
For Cohort 1, at enrollment, body mass index (BMI) less than or equal to 31.5 kg/m^2
At enrollment, willing and able to comply with the study visit schedule and other study requirements, as determined by the site investigator or designee
Confirmed HIV-1-infection based on documented testing of two samples collected at different time points. More information on this criterion can be found in the protocol.
For at least 3 consecutive months (defined as 90 consecutive days) prior to screening, and prior to enrollment, has been on stable unchanged cART consisting of 2 or more drugs from 2 or more classes of antiretroviral drugs, ascertainment of this criterion may be based on parent or guardian report only, but available medical records should also be reviewed in relation to this criterion.
Has at least one documented plasma HIV-1 RNA less than the lower limit of detection of the assay from a specimen collected 6 to 12 months (defined as 180 to 365 days) prior to entry. OR
Has at least one documented plasma HIV-1 RNA less than the lower limit of detection of the assay from a specimen collected less than 6 months (defined as within 179 days) prior to entry and at least one documented plasma HIV-1 RNA result less than the lower limit of detection of the assay from a specimen collected in the 12-18 months (defined as 365 to 545 days) prior to entry.
OR
For Cohort 1 participants enrolling to Cohort 2, has documented plasma HIV-1 RNA results less than the lower limit of detection of the assay from all indicated Cohort 1 study visits with their Cohort 1 Week 16 visit completed within 28 days prior to Cohort 2 entry.
At screening, has Grade 2 or lower of all the following laboratory test results:
At screening, is on an atazanavir-containing (ATV) cART regimen, and has total bilirubin less than or equal to 1.5 mg/dL or normal direct bilirubin
At screening, has documented plasma HIV-1 RNA less than 50 copies/mL
At screening, mean value of Q-T interval (QTc) interval (automated machine readout or calculated using either Bazett or Fredericia) on ECG performed in triplicate, less than or equal to 500 msec.
For females, has a negative (blood or urine) human chorionic gonadotropin (hCG) laboratory test result at entry
For females of childbearing potential, at entry, currently using at least one allowable effective method of contraception, and agrees to use at least one allowable effective method of contraception throughout study participation, for at least 30 days after discontinuation of oral study product, and for at least 48 weeks after discontinuation of CAB LA and/or RPV LA, and intending to delay any planned pregnancies until 30 days after last oral study product use or until 48 weeks after last injectable study product use.
For Cohort 1 participants enrolling to Cohort 2, have completed all scheduled product injections and completed Week 16 visit in Cohort 1 Step 2
Exclusion Criteria: Cohort 1 Step 1, Cohort 2 Step 3, or Cohort 2 Step 5
Adolescents will be excluded from the study if any of the following are identified during the screening period:
Within 6 months (defined as within 179 days) prior to entry, two consecutive documented HIV-1 RNA values greater than the lower limit of detection of the assay
For Cohort 1 participants enrolling to Cohort 2, Step 3, occurrence of any Grade 3 or higher adverse event assessed as related to study product or permanent discontinuation of study product due to an adverse event of any grade assessed as related to study product during participation in Cohort 1 (including any long-term safety and washout PK follow-up visits).
For participants enrolling to Cohort 1 Step 1, based on available medical records, currently on either a cART regimen containing both a protease inhibitor (PI) and an integrase strand transfer inhibitor (INSTI), or a cART regimen containing both an INSTI and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
As determined by the IoR or designee, and based on available medical records, known or suspected resistance to RPV
As determined by the IoR or designee based on available medical records, known or suspected resistance to INSTIs
History of congestive heart failure, symptomatic arrhythmia, or any clinically significant cardiac disease, as determined by the IoR or designee based on available medical records
At entry, known active tuberculosis infection, requiring anti-tuberculosis treatment, as determined by the IoR or designee based on available medical records
Known hepatitis B or hepatitis C infection, as determined by the IoR or designee based on available medical records
Clinically significant hepatic disease, as determined by the IoR or designee based on available medical records
Current or anticipated need for chronic anti-coagulation, as determined by the IoR or designee, based on available medical records
History of sensitivity to heparin or heparin-induced thrombocytopenia, as determined by the IoR or designee, based on available medical records
History of known or suspected bleeding disorder including history of prolonged bleeding, as determined by the IoR or designee, based on available medical records
Known or suspected allergy to study product components
More than one seizure within one year (defined as within 365 days) prior to entry, or unstable or poorly controlled seizure disorder, as determined by the IoR or designee, based on available medical records.
At entry, participant is receiving (or has received in the last 7 days) any disallowed medication listed in the study protocol.
Current inflammatory skin condition that compromises the safety of intramuscular injections as determined by the IoR or designee.
Has a tattoo or other dermatological condition overlying the buttock region which, in the opinion of the IoR or designee, may interfere with interpretation of injection site reactions
Surgically-placed, or planned, buttock implants, per self-report
For females, lactating (per self-report and/or parent/guardian report) at entry
Enrolled in another clinical trial of an investigational agent, device, or vaccine
Any other condition or social circumstance situation that, in the opinion of the IoR or designee, would make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Inclusion/Exclusion Criteria, Step 2 (Cohort 1 Progression Criteria, Step 1 to Step 2)
Cohort 1 Step 1 participants will be assessed for eligibility to progress from the oral lead-in phase (Step 1) to the injection phase (Step 2) primarily based on the safety assessments from the Cohort 1 Step 1 Week 4a study visit. Clinical assessments conducted prior to administering the first injection at the Week 4b visit will also be used to confirm eligibility to receive the injectable study product. See the study protocol for Week 4a and Week 4b visit scheduling, order of procedures, and visit windows, respectively.
All of the following criteria must be met in order for participants to be included in Cohort 1 Step 2:
Currently enrolled in Cohort 1, Step 1
At Cohort 1 Step 1 Week 4a study visit, or from confirmatory repeat testing of Cohort 1 Step 1 Week 4a study visit laboratory tests, has Grade 2 or lower of all the following laboratory test results:
For females, at Cohort 1 Step 1 Week 4b study visit, has a negative hCG laboratory test result
Assessed by the IoR or designee as sufficiently adherent in Step 1 to permit an adequate evaluation of safety and tolerability as part of the oral lead-in phase prior to entry into the injection phase
Participants who meet any of the following criteria will be excluded from Cohort 1 Step 2:
Inclusion/Exclusion Criteria, Step 4 (Cohort 2 Progression Criteria, Step 3 to Step 4)
Cohort 2 Step 3 participants will be assessed for eligibility to progress from the oral lead-in phase (Step 3) to the injection phase (Step 4) primarily based on the safety assessments from the Cohort 2 Step 3 Week 4a study visit. Clinical assessments conducted prior to administering the first injection at the Week 4b visit will also be used to confirm eligibility to receive the injectable study product. See the study protocol for Week 4a and Week 4b visit scheduling, order of procedures, and target visit windows, respectively.
All of the following criteria must be met in order for participants to be included in Cohort 2 Step 4:
Currently enrolled in Cohort 2, Step 3
At Cohort 2 Step 3 Week 4a study visit, or from confirmatory repeat testing of Cohort 2 Step 3 Week 4a study visit laboratory tests, has Grade 2 or lower of the following laboratory test results:
For females, at Cohort 2 Step 3 Week 4b study visit, has a negative hCG laboratory test result
Assessed by the IoR or designee as sufficiently adherent in Step 3 to permit an adequate evaluation of safety and tolerability as part of the oral lead-in phase prior to entry into the injection phase
Participants who meet any of the following criteria will be excluded from Cohort 2 Step 4:
Inclusion/Exclusion Criteria: Parents/Caregivers
Selected parents or caregivers of adolescents may be enrolled to complete qualitative phone interviews. See the study protocol for more information regarding the selection process, and coordination of scheduling the interviews. All of the following criteria must be met for the parent/caregiver to be enrolled:
Selected by the protocol team for participation in the study
Willing and able to provide informed (verbal or written) consent for study participation
Per the adolescent participant, has knowledge of how the adolescent participant tolerated the study product, and lives with or has regular supportive contact with the adolescent participant
Per parent/caregiver self-report, has knowledge of how the participant tolerated the study product, and lives with or has regular supportive contact with the adolescent participant
Willing and able to complete interview in English by phone
Parents and/or caregivers of participants who meet the following criterion will be excluded from study participation:
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| Name | Affiliation | Role |
|---|---|---|
| Carolyn Bolton Moore, MSc, MBBCh | Centre for Infectious Disease Research in Zambia/University of Alabama Birmingham | Study Chair |
| Aditya H. Gaur, MD | St. Jude Children's Research Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Usc La Nichd Crs | Los Angeles | California | 90089 | United States | ||
| Univ. of Colorado Denver NICHD CRS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38538160 | Result | Gaur AH, Capparelli EV, Calabrese K, Baltrusaitis K, Marzinke MA, McCoig C, Van Solingen-Ristea RM, Mathiba SR, Adeyeye A, Moye JH, Heckman B, Lowenthal ED, Ward S, Milligan R, Samson P, Best BM, Harrington CM, Ford SL, Huang J, Crauwels H, Vandermeulen K, Agwu AL, Smith-Anderson C, Camacho-Gonzalez A, Ounchanum P, Kneebone JL, Townley E, Bolton Moore C; IMPAACT 2017 Collaborators; IMPAACT 2017 Team. Safety and pharmacokinetics of oral and long-acting injectable cabotegravir or long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study. Lancet HIV. 2024 Apr;11(4):e211-e221. doi: 10.1016/S2352-3018(23)00300-4. | |
| 38538161 |
| Label | URL |
|---|---|
| Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (Corrected Version 2.1 - July 2017) | View source |
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Individual participant data that underlie results in the publication, after deidentification.
Beginning 3 months following publication and available throughout period of funding of the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) Network by NIH.
With whom?
For what types of analyses?
By what mechanism will data be made available?
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55 participants were enrolled into Cohort 1C/1R, and 44 of these participants continued to Cohort 2. An additional 100 participants enrolled into Cohort 2. Parents/caregivers (n = 13) are not included in the participant flow result section because no baseline measurements were collected for these participants. In addition, no data collected from these participants contributed to the reporting of results for primary or secondary objectives.
Accrual for Cohort 1 occurred between April 2019 and November 2021 at 15 different medical clinic sites across Botswana, South Africa, Thailand, and the United States. Accrual for Cohort 2 occurred between July 2021 and August 2022 at 18 different medical clinic sites across Botswana, South Africa, Thailand, Uganda, and the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1C: CAB | Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks. Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12). Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8). Oral Cabotegravir (CAB): 30 mg tablets administered orally Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Cohort 1 Treatment Initiation to Week 16 |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: V4.0 | May 27, 2022 | Feb 7, 2024 |
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|
| Cohort 2B: CAB LA + RPV LA | Experimental | Step 5: First and second injections: CAB LA administered as a 600 mg IM injection and RPV LA administered as a 900 mg IM injection at Entry and at Week 4. Subsequent injections: starting at Week 12, CAB LA administered as a 600 mg IM injection and RPV LA administered as 900 mg IM injection every eight weeks through Week 92 or final safety extension visit. |
|
| Oral Rilpivirine (RPV) | Drug | 25 mg tablets administered orally |
|
|
| Long-Acting Injectable Cabotegravir (CAB LA) | Drug | Administered by intramuscular (IM) injection |
|
| Long-Acting Injectable Rilpivirine (RPV LA) | Drug | Administered by intramuscular (IM) injection |
|
| Combination Antiretroviral Therapy (cART) | Drug | Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study. |
|
| Cohort 1 Treatment Initiation through Week 4 |
| Proportion of Participants Who Permanently Discontinued Study Product Due to Adverse Events Assessed as Related to Study Product/s (Cohort 1) | We present the proportion of participants who permanently discontinued study product due to adverse events (AEs) assessed as related to study product by the site investigator of record through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI). | Cohort 1 Treatment Initiation through Week 4 |
| Proportion of Participants Who Died Due to Adverse Events Assessed as Related to Study Product/s (Cohort 1) | We present the proportion of participants who died due to adverse events assessed as related to study product by the site investigator of record through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI). | Cohort 1 Treatment Initiation through Week 4 |
| Proportion of Participants Who Had Grade 3 or Higher Adverse Events (Cohort 1) | Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE through 16 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI). | Cohort 1 Treatment Initiation through Week 16 |
| Proportion of Participants Who Had Grade 3 or Higher Adverse Events Assessed as Related to Study Product/s (Cohort 1) | Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE assessed as related to study product by the site investigator of record through 16 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI). | Cohort 1 Treatment Initiation through Week 16 |
| Proportion of Participants Who Had Serious Adverse Events Meeting International Conference on Harmonisation (ICH) Criteria Assessed as Related to Study Product/s (Cohort 1) | Adverse events (AE) were assessed as a Serious AE by ICH criteria. Per ICH, a serious AE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect (see references for additional details). We present the proportion of participants with at least one serious AE assessed as related to study product by the site investigator of record through 16 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI). | Cohort 1 Treatment Initiation through Week 16 |
| Proportion of Participants Who Permanently Discontinued Study Product Due to Adverse Events Assessed as Related to Study Product/s (Cohort 1) | We present the proportion of participants who permanently discontinued study product due to adverse events (AEs) assessed as related to study product by the site investigator of record through 16 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI). | Cohort 1 Treatment Initiation through Week 16 |
| Proportion of Participants Who Died Due to Adverse Events Assessed as Related to Study Product/s (Cohort 1) | We present the proportion of participants who died due to adverse events assessed as related to study product by the site investigator of record through 16 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI). | Cohort 1 Treatment Initiation through Week 16 |
| Proportion of Participants Who Had Grade 3 or Higher Adverse Events (Cohort 2) | Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI). | Cohort 2 Treatment Initiation through Week 24 |
| Proportion of Participants Who Had Grade 3 or Higher Adverse Events Assessed as Related to Study Product/s (Cohort 2) | Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE assessed as related to study product by the site investigator of record through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI). | Cohort 2 Treatment Initiation through Week 24 |
| Proportion of Participants Who Had Serious Adverse Events Meeting ICH Criteria Assessed as Related to Study Product/s (Cohort 2) | Adverse events (AE) were assessed as a Serious AE by ICH criteria. Per ICH, a serious AE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect (see references for additional details). We present the proportion of participants with at least one serious AE assessed as related to study product by the site investigator of record through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI). | Cohort 2 Treatment Initiation through Week 24 |
| Proportion of Participants Who Permanently Discontinued Study Product Due to Adverse Events Assessed as Related to Study Product/s (Cohort 2) | We present the proportion of participants who permanently discontinued study product due to adverse events (AEs) assessed as related to study product by the site investigator of record through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI). | Cohort 2 Treatment Initiation through Week 24 |
| Proportion of Participants Who Died Due to Adverse Events Assessed as Related to Study Product/s (Cohort 2) | We present the proportion of participants who died due to adverse events assessed as related to study product by the site investigator of record through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI). | Cohort 2 Treatment Initiation through Week 24 |
| Geometric Mean Area Under the Plasma Concentration-time Curve (AUC) for Step 1 Oral CAB (Cohort 1C) | AUC calculated using non-compartmental methods with linear up-log down trapezoidal rule (Phoenix WinNonlin v 8.3, Certara®). We present the geometric mean of the AUC with associated geometric coefficient of variation. | Week 2: Samples collected pre-dose and 1, 2, 3, 4, 8, and (for Q4W dosing) 24 hours post-dose |
| Apparent Total Body Clearance (CL/F) of Step 1 Oral CAB (Cohort 1C) | We present the geometric mean of the total body clearance of CAB and associated geometric coefficient of variation, based on analysis of intensive pharmacokinetic (PK) samples. | Week 2: Samples collected pre-dose and 1, 2, 3, 4, 8 and (for Q4W dosing) 24 hours post-dose |
| Geometric Mean Maximum Plasma Concentration (Cmax) of Oral CAB (Cohort 1C) | We present the geometric mean of the maximum plasma concentration of CAB and associated geometric coefficient of variation, based on analysis of intensive PK samples | Week 2: Samples collected pre-dose and 1, 2, 3, 4, 8 and (for Q4W dosing) 24 hours post-dose |
| Time of Maximum Concentration (Tmax) of Oral CAB (Cohort 1C) | We present the mean time of maximum concentration of CAB and associated standard deviation, based on analysis of intensive PK samples. | Week 2: Samples collected pre-dose and 1, 2, 3, 4, 8, and (for Q4W dosing) 24 hours post-dose |
| Geometric Mean Pre-dose Concentration (C0) of Oral CAB (Cohort 1C) | We present the geometric mean pre-dose CAB concentration and associated geometric coefficient of variation, based on analysis of intensive PK samples. | Week 2: Samples collected pre-dose and 1, 2, 3, 4, 8, and (for Q4W dosing) 24 hours post-dose |
| Geometric Mean Concentration of LA CAB/LA RPV at Week 16 (Cohort 1 Q4W) | We present the geometric mean concentration of LA CAB/LA RPV and associated geometric coefficients of variation for participants on the Q4W dosing regimen, based on analysis of pre-dose PK sample. | Week 16 |
| Geometric Mean Maximum Plasma Concentration (Cmax) of LA CAB/LA RPV (Cohort 1 Q4W) | We present the geometric mean of the maximum plasma concentration of LA CAB/LA RPV and associated geometric coefficient of variation for the first injection in participants on the Q4W dosing regimen, based on analysis of intensive PK samples. | Samples collected at Weeks 4b, 5, 6, and 8 |
| Time of Maximum Concentration (Tmax) of LA CAB/LA RPV (Cohort 1 Q4W) | We present the mean time of maximum concentration of LA CAB/LA RPV at the first injection and associated standard deviation for participants on the Q4W dosing regimen, based on analysis of intensive PK samples. | Samples collected at Weeks 4b, 5, 6, 8 |
| Geometric Mean Pre-dose Concentration (C0) of LA CAB/LA RPV (Cohort 1 Q4W) | We present the geometric mean pre-dose concentrations of each injection and associated geometric coefficient of variation for participants on the Q4W dosing regimen, based on analysis of pre-dose PK samples. | Week 4b, Week 8, Week 12 |
| Geometric Mean Concentration of LA CAB/LA RPV at Week 16 (Cohort 1 Q8W) | We present the geometric mean concentration of LA CAB/LA RPV and associated geometric coefficients of variation for participants on the Q4W dosing regimen, based on analysis of the pre-dose PK sample. | Week 16 |
| Geometric Mean Maximum Plasma Concentration (Cmax) of LA CAB/LA RPV (Cohort 1 Q8W) | We present the geometric mean of the maximum plasma concentration of LA CAB/LA RPV and associated geometric coefficient of variation for the first injection in participants on the Q8W dosing regimen, based on analysis of intensive PK samples. | Samples collected at Weeks 4b, 5, and 8 |
| Time of Maximum Concentration (Tmax) of LA CAB/LA RPV (Cohort 1 Q8W) | We present the mean time of maximum concentration of LA CAB/LA RPV at the first injection and associated standard deviation for participants on the Q8W dosing regimen, based on analysis of intensive PK samples. | Samples collected at Weeks 4b, 5, and 8 |
| Geometric Mean Pre-dose Concentration (C0) of LA CAB/LA RPV (Cohort 1 Q8W) | We present the geometric mean pre-dose concentration of the first injection and associated geometric coefficient of variation for participants on the Q4W dosing regimen, based on analysis of pre-dose PK samples. | Week 4b, Week 8 |
Results collected via administration of Pain During Injection survey to participants after receiving injection. Pain during injections was assessed using the Faces Pain Scale-Revised which includes 6 visual and text options: "no hurt," "hurts little bit," "hurts little more," "hurts even more," "hurts whole lot" and "hurts worst". |
| Week 8 |
| Median Dimension of Quality of Life Scores | A commonly used 23-item Pediatric Quality of Life Inventory, the PedsQLTM, was used to measure physical, emotional, and social dimensions of health as well as school functioning. Question responses were used to generate scores from 0-100 (100 being the best quality of life) based on the PedsQLTM guidelines. The number of participants drops slightly for the school functioning result as not all participants are eligible to answer these school-related questions. | Week 16 |
| Proportion of Participants Who Had Grade 3 or Higher Adverse Events (Cohort 2) | Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE through 48 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI). | Cohort 2 treatment initiation through Week 48 |
| Proportion of Participants Who Had Grade 3 or Higher Adverse Events Assessed as Related to Study Product/s (Cohort 2) | Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE assessed as related to study product by the site investigator of record through 48 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI). | Cohort 2 treatment initiation through Week 48 |
| Proportion of Participants Who Had Serious Adverse Events Meeting ICH Criteria, as Cited in References, Assessed as Related to Study Product/s (Cohort 2) | Adverse events (AE) were assessed as a Serious AE by ICH criteria. Per ICH, a serious AE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect (see references for additional details). We present the proportion of participants with at least one serious AE assessed as related to study product by the site investigator of record through 48 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI). | Cohort 2 treatment initiation through Week 48 |
| Proportion of Participants Who Permanently Discontinued Study Product Due to Adverse Events Assessed as Related to Study Product/s (Cohort 2) | We present the proportion of participants who permanently discontinued study product due to adverse events (AEs) assessed as related to study product by the site investigator of record through 48 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI). | Cohort 2 treatment initiation through Week 48 |
| Proportion of Participants Who Died Due to Adverse Events Assessed as Related to Study Product/s (Cohort 2) | We present the proportion of participants who died due to adverse events assessed as related to study product by the site investigator of record through 48 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI). | Cohort 2 treatment initiation through Week 48 |
| Proportion of Participants With Plasma HIV-1 RNA >= 50 Copies/mL Per the FDA Snapshot (Cohort 2) | We present the proportion of participants with HIV-1 RNA >= 50 copies/mL and associated exact 95% CI (Clopper-Pearson) per the FDA snapshot, based on laboratory evaluations. | Week 24 |
| Proportion of Participants With Plasma HIV-1 RNA >= 200 Copies/mL Per the FDA Snapshot (Cohort 2) | We present the proportion of participants with HIV-1 RNA >= 200 copies/mL and associated exact 95% CI (Clopper-Pearson) per the FDA snapshot, based on laboratory evaluations. | Week 24 |
| Proportion of Participants With Plasma HIV-1 RNA >= 50 Copies/mL Per the FDA Snapshot (Cohort 2) | We present the proportion of participants with HIV-1 RNA >= 50 copies/mL and associated exact 95% CI (Clopper-Pearson) per the FDA snapshot, based on laboratory evaluations. | Week 48 |
| Proportion of Participants With Plasma HIV-1 RNA >= 200 Copies/mL Per the FDA Snapshot (Cohort 2) | We present the proportion of participants with HIV-1 RNA >= 200 copies/mL and associated exact 95% CI (Clopper-Pearson) per the FDA snapshot, based on laboratory evaluations. | Week 48 |
| Geometric Mean Pre-dose Concentration (C0) of Oral CAB and Oral RPV (Cohort 2) | We present the geometric mean of the pre-dose concentration of oral CAB and oral RPV and associated coefficient of variation, based on analysis of pre-dose PK sample. | Week 2 |
| Geometric Mean Ratio of Pre-dose CAB and RPV Concentrations at Week 24: Pre-dose CAB and RPV Concentrations at Week 8 (Cohort 2) | We present the geometric mean of the ratios of pre-dose CAB and RPV concentrations at Week 24:Week 8 and associated coefficient of variation, based on analysis of pre-dose PK samples. | Week 8 and Week 24 |
| Geometric Mean Ratio of Pre-dose CAB and RPV Concentrations at Week 24: Pre-dose CAB and RPV Concentrations at Week 16 (Cohort 2) | We present the geometric mean of the ratios of pre-dose CAB and RPV concentrations at Week 24:Week 16 and associated coefficient of variation, based on analysis of pre-dose PK samples. | Week 16 and Week 24 |
| Geometric Mean Ratio of Pre-dose CAB and RPV Concentrations at Week 48: Pre-dose CAB and RPV Concentrations at Week 8 (Cohort 2) | We present the geometric mean of the ratios of pre-dose CAB and RPV concentrations at Week 48:Week 8 and associated coefficient of variation, based on analysis of pre-dose PK samples. | Week 8 and Week 48 |
| Geometric Mean Ratio of Pre-dose CAB and RPV Concentrations at Week 48: Pre-dose CAB and RPV Concentrations at Week 16 (Cohort 2) | We present the geometric mean of the ratios of pre-dose CAB and RPV concentrations at Week 48:Week 16 and associated coefficient of variation, based on analysis of pre-dose PK samples. | Week 16 and Week 48 |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Pediatric Perinatal HIV NICHD CRS, Site 5127 | Miami | Florida | 33136 | United States |
| Emory University School of Medicine NICHD CRS | Atlanta | Georgia | 30322 | United States |
| Lurie Children's Hospital of Chicago (LCH) CRS | Chicago | Illinois | 60614-3393 | United States |
| Johns Hopkins Univ. Baltimore NICHD CRS | Baltimore | Maryland | 21287 | United States |
| St. Jude Children's Research Hospital CRS | Memphis | Tennessee | 38105-3678 | United States |
| Baylor College of Medicine/ Texas Children's Hospital NICHD CRS | Houston | Texas | 77030 | United States |
| Gaborone CRS | Gaborone | South-East District | Botswana |
| Molepolole CRS, Site 12702 | Molepolole | Botswana |
| Famcru Crs | Tygerberg Hills | Western Cape | 7505 | South Africa |
| Wits RHI Shandukani Research Centre CRS | Johannesburg | 2001 | South Africa |
| Soweto CRS, Site 8052 | Soweto | 1862 | South Africa |
| Umlazi CRS | Umlazi | 4066 | South Africa |
| Siriraj Hospital Mahidol University | Bangkok | 10700 | Thailand |
| Chiangrai Prachanukroh Hospital NICHD CRS | Chiang Mai | 50100 | Thailand |
| Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS | Chiang Mai | 50200 | Thailand |
| Baylor-Uganda CRS | Kampala | 72052 | Uganda |
| MU-JHU Care Limited CRS | Kampala | Uganda |
| Result |
| Lowenthal ED, Chapman J, Ohrenschall R, Calabrese K, Baltrusaitis K, Heckman B, Yin DE, Agwu AL, Harrington C, Van Solingen-Ristea RM, McCoig CC, Adeyeye A, Kneebone J, Chounta V, Smith-Anderson C, Camacho-Gonzalez A, D'Angelo J, Bearden A, Crauwels H, Huang J, Buisson S, Milligan R, Ward S, Bolton-Moore C, Gaur AH; IMPAACT 2017 Collaborators; IMPAACT 2017 Team. Acceptability and tolerability of long-acting injectable cabotegravir or rilpivirine in the first cohort of virologically suppressed adolescents living with HIV (IMPAACT 2017/MOCHA): a secondary analysis of a phase 1/2, multicentre, open-label, non-comparative dose-finding study. Lancet HIV. 2024 Apr;11(4):e222-e232. doi: 10.1016/S2352-3018(23)00301-6. |
| 41547359 | Derived | Gaur AH, Baltrusaitis K, Capparelli EV, Moye JH, Yin DE, Masheto G, Buisson S, Harrington CM, Marzinke MA, Lowenthal ED, Scheckter R, Ace A, Ward S, Milligan R, Whitson K, Huang J, Cheung SYA, Best BM, Townley E, Roberts G, Kakuda TN, Birmingham E, Mathiba SR, Aurpibul L, Korutaro V, Smith C, Patel F, Moodley E, Bolton-Moore C; IMPAACT 2017 Collaborators; IMPAACT 2017 Team. Safety, antiviral activity, and pharmacokinetics of long-acting injectable cabotegravir-rilpivirine in virologically suppressed adolescents living with HIV-1 (IMPAACT 2017/MOCHA): 48-week results of a multinational, phase 1/2, single-arm study. Lancet HIV. 2026 Feb;13(2):e85-e94. doi: 10.1016/S2352-3018(25)00242-5. Epub 2026 Jan 14. |
| 41547358 | Derived | Lowenthal ED, Chapman J, Baltrusaitis K, Kovic G, Merchant S, Branch K, Tsosie C, Vaca MZ, Heckman B, Van Solingen-Ristea RM, Harrington CM, Yin DE, Townley E, Whitton M, Agwu AL, Smith C, Paul ME, Violari A, Moodley E, Owor M, Chokephaibulkit K, Fry S, Jao J, Mitchell CD, Buisson S, Ace A, Kolobova I, Bolton-Moore C, Gaur AH; IMPAACT 2017 Collaborators; IMPAACT 2017 Team. Acceptability and tolerability of long-acting injectable cabotegravir-rilpivirine in adolescents with HIV-1 (IMPAACT 2017/MOCHA): 48-week results of a multicentre, open-label, non-comparative phase 1/2 trial. Lancet HIV. 2026 Feb;13(2):e95-e103. doi: 10.1016/S2352-3018(25)00241-3. Epub 2026 Jan 14. |
| 40655875 | Derived | Okesanya OJ, Ayeni RA, Amadin P, Ngwoke I, Amisu BO, Ukoaka BM, Ahmed MM, Oso TA, Musa SS, Lucero-Prisno DE. Advances in HIV Treatment and Vaccine Development: Emerging Therapies and Breakthrough Strategies for Long-Term Control. AIDS Res Treat. 2025 Jul 4;2025:6829446. doi: 10.1155/arat/6829446. eCollection 2025. |
| 40049924 | Derived | Moore CB, Baltrusaitis K, Best BM, Moye JH, Townley E, Violari A, Heckman B, Buisson S, Van Solingen-Ristea RM, Capparelli EV, Marzinke MA, Lowenthal ED, Ward S, Krotje C, Milligan R, Agwu AL, Huang J, Cheung SYA, McCoig C, Yin DE, Roberts G, Crauwels H, Van Eygen V, Zabih S, Masheto G, Ounchanum P, Aurpibul L, Korutaro V, Gaur AH; IMPAACT 2017 Collaborators for the IMPAACT 2017 Team. Safety of combined long-acting injectable cabotegravir and long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study. Lancet HIV. 2025 Mar;12(3):e191-e200. doi: 10.1016/S2352-3018(24)00344-8. |
| Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010 | View source |
| ICH Criteria for Meeting Serious Adverse Events | View source |
| FG001 | Cohort 1R: RPV | Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks. Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12). Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8). Oral Rilpivirine (RPV): 25 mg tablets administered orally Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study. |
| FG002 | Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA | Step 3: CAB administered orally as one 30 mg tablet once daily and RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit for 4-6 weeks. Step 4: First and second injections: CAB LA administered as a 600 mg IM injection and RPV LA administered as a 900 mg IM injection at Week 4b and at Week 8. Subsequent injections: starting at Week 16, CAB LA administered as a 600 mg IM injection and RPV LA administered as a 900 mg IM injection every eight weeks through Week 96 or final safety extension visit. Oral Cabotegravir (CAB): 30 mg tablets administered orally Oral Rilpivirine (RPV): 25 mg tablets administered orally Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection |
| FG003 | Cohort 2B: CAB LA + RPV LA | Step 5: First and second injections: CAB LA administered as a 600 mg IM injection and RPV LA administered as a 900 mg IM injection at Entry and at Week 4. Subsequent injections: starting at Week 12, CAB LA administered as a 600 mg IM injection and RPV LA administered as 900 mg IM injection every eight weeks through Week 92 or final safety extension visit. Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection |
| COMPLETED |
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| NOT COMPLETED |
|
|
| Cohort 1 Week 16 Through End of Cohort 1 |
|
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| Cohort 2 Treatment Initiation to Week 24 |
|
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| Cohort 2 Week 24 to Week 48 |
|
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| Cohort 2 Week 48 to Week 96 |
|
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| Cohort 2 Safety Extension |
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Participants who have taken at least 1 dose of any study product on the respective cohort. For participants enrolled in both Cohort 1 and Cohort 2, the baseline value summarized is from the corresponding cohort. Baseline characteristics for parents/caregivers are not reported.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1C: CAB | Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks. Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12). Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8). Oral Cabotegravir (CAB): 30 mg tablets administered orally Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study. |
| BG001 | Cohort 1R: RPV | Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks. Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12). Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8). Oral Rilpivirine (RPV): 25 mg tablets administered orally Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study. |
| BG002 | Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA | Step 3: CAB administered orally as one 30 mg tablet once daily and RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit for 4-6 weeks. Step 4: First and second injections: CAB LA administered as a 600 mg IM injection and RPV LA administered as a 900 mg IM injection at Week 4b and at Week 8. Subsequent injections: starting at Week 16, CAB LA administered as a 600 mg IM injection and RPV LA administered as a 900 mg IM injection every eight weeks through Week 96 or final safety extension visit. Oral Cabotegravir (CAB): 30 mg tablets administered orally Oral Rilpivirine (RPV): 25 mg tablets administered orally Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection |
| BG003 | Cohort 2B: CAB LA + RPV LA | Step 5: First and second injections: CAB LA administered as a 600 mg IM injection and RPV LA administered as a 900 mg IM injection at Entry and at Week 4. Subsequent injections: starting at Week 12, CAB LA administered as a 600 mg IM injection and RPV LA administered as 900 mg IM injection every eight weeks through Week 92 or final safety extension visit. Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age is summarized as age at first enrollment to either Cohort 1 or Cohort 2. | Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants. | Median | Full Range | years |
| ||||||||
| Age, Customized | Age is summarized as age at first enrollment to either Cohort 1 or Cohort 2. | Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants. | Count of Participants | Participants |
| |||||||||
| Sex: Female, Male | Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants. | Count of Participants | Participants |
| ||||||||||
| Ethnicity (NIH/OMB) | Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants. | Count of Participants | Participants |
| ||||||||||
| Race (NIH/OMB) | Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants. | Count of Participants | Participants |
| ||||||||||
| Region of Enrollment, Customized | Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants. | Count of Participants | Participants |
| ||||||||||
| HIV-1 RNA | The last available HIV-1 RNA viral load on or before the first dose of treatment for the corresponding cohort. | Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants. | Count of Participants | Participants |
| |||||||||
| Quality of Life Dimension Scores | Calculated dimension scores from the PedsQL: Pediatric Quality of Life Inventory range from 0 (worst) to 100 (best). | Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants. Questions used for School Functioning Dimension are only answered by participants who are attempting school at the time of the evaluation. One participant in Cohort 1R and 11 participants in Cohort 2 did not respond to these questions. | Median | Inter-Quartile Range | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Participants Who Had Grade 3 or Higher Adverse Event (Cohort 1) | Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an AE severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI). | Cohort 1 Evaluable: Cohort 1 participants who were treated exclusively on the dose being evaluated for a given cohort, and either (1) completed all treatment regimen through Cohort 1 Week 4 and completed the Week 4 visit or (2) experienced any of the following: death attributable to the study product; study product-related Grade 3 or higher event (excluding injection site adverse events); OR permanently discontinued from treatment due to study product-related toxicity (regardless of grade). | Posted | Number | 95% Confidence Interval | proportion of participants | Cohort 1 Treatment Initiation through Week 4 |
|
|
| |||||||||||||||||||||||||
| Primary | Proportion of Participants Who Had Grade 3 or Higher Adverse Events Assessed as Related to Study Product/s (Cohort 1) | Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an AE severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE assessed as related by the site investigator of record to study product through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI). | Cohort 1 Evaluable: Cohort 1 participants who were treated exclusively on the dose being evaluated for a given cohort, and either (1) completed all treatment regimen through Cohort 1 Week 4 and completed the Week 4 visit or (2) experienced any of the following: death attributable to the study product; study product-related Grade 3 or higher event (excluding injection site adverse events); OR permanently discontinued from treatment due to study product-related toxicity (regardless of grade) | Posted | Number | 95% Confidence Interval | proportion of participants | Cohort 1 Treatment Initiation through Week 4 |
| |||||||||||||||||||||||||||
| Primary | Proportion of Participants Who Had Serious Adverse Events Meeting International Conference on Harmonisation (ICH) Criteria Assessed as Related to Study Product/s (Cohort 1) | Adverse events (AE) were assessed as a Serious AE by ICH criteria. Per ICH, a serious AE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect (see references for additional details). We present the proportion of participants with at least one serious AE assessed as related to study product by the site investigator of record through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI). | Cohort 1 Evaluable: Cohort 1 participants who were treated exclusively on the dose being evaluated for a given cohort, and either (1) completed all treatment regimen through Cohort 1 Week 4 and completed the Week 4 visit or (2) experienced any of the following: death attributable to the study product; study product-related Grade 3 or higher event (excluding injection site adverse events); OR permanently discontinued from treatment due to study product-related toxicity (regardless of grade). | Posted | Number | 95% Confidence Interval | proportion of participants | Cohort 1 Treatment Initiation through Week 4 |
| |||||||||||||||||||||||||||
| Primary | Proportion of Participants Who Permanently Discontinued Study Product Due to Adverse Events Assessed as Related to Study Product/s (Cohort 1) | We present the proportion of participants who permanently discontinued study product due to adverse events (AEs) assessed as related to study product by the site investigator of record through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI). | Cohort 1 Evaluable: Cohort 1 participants who were treated exclusively on the dose being evaluated for a given cohort, and either (1) completed all treatment regimen through Cohort 1 Week 4 and completed the Week 4 visit or (2) experienced any of the following: death attributable to the study product; study product-related Grade 3 or higher event (excluding injection site adverse events); OR permanently discontinued from treatment due to study product-related toxicity (regardless of grade) | Posted | Number | 95% Confidence Interval | proportion of participants | Cohort 1 Treatment Initiation through Week 4 |
| |||||||||||||||||||||||||||
| Primary | Proportion of Participants Who Died Due to Adverse Events Assessed as Related to Study Product/s (Cohort 1) | We present the proportion of participants who died due to adverse events assessed as related to study product by the site investigator of record through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI). | Cohort 1 Evaluable: Cohort 1 participants who were treated exclusively on the dose being evaluated for a given cohort, and either (1) completed all treatment regimen through Cohort 1 Week 4 and completed the Week 4 visit or (2) experienced any of the following: death attributable to the study product; study product-related Grade 3 or higher event (excluding injection site adverse events); OR permanently discontinued from treatment due to study product-related toxicity (regardless of grade) | Posted | Number | 95% Confidence Interval | proportion of participants | Cohort 1 Treatment Initiation through Week 4 |
| |||||||||||||||||||||||||||
| Primary | Proportion of Participants Who Had Grade 3 or Higher Adverse Events (Cohort 1) | Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE through 16 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI). | Cohort 1 Evaluable: Cohort 1 participants who were treated exclusively on the dose being evaluated for a given cohort, and either (1) completed all treatment regimen through Cohort 1 Week 16 and completed the Week 16 visit or (2) experienced any of the following: death attributable to the study product; study product-related Grade 3 or higher event (excluding injection site adverse events); OR permanently discontinued from treatment due to study product-related toxicity (regardless of grade) | Posted | Number | 95% Confidence Interval | proportion of participants | Cohort 1 Treatment Initiation through Week 16 |
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| Primary | Proportion of Participants Who Had Grade 3 or Higher Adverse Events Assessed as Related to Study Product/s (Cohort 1) | Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE assessed as related to study product by the site investigator of record through 16 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI). | Cohort 1 Evaluable: Cohort 1 participants who were treated exclusively on the dose being evaluated for a given cohort, and either (1) completed all treatment regimen through Cohort 1 Week 16 and completed the Week 16 visit or (2) experienced any of the following: death attributable to the study product; study product-related Grade 3 or higher event (excluding injection site adverse events); OR permanently discontinued from treatment due to study product-related toxicity (regardless of grade) | Posted | Number | 95% Confidence Interval | proportion of participants | Cohort 1 Treatment Initiation through Week 16 |
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| Primary | Proportion of Participants Who Had Serious Adverse Events Meeting International Conference on Harmonisation (ICH) Criteria Assessed as Related to Study Product/s (Cohort 1) | Adverse events (AE) were assessed as a Serious AE by ICH criteria. Per ICH, a serious AE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect (see references for additional details). We present the proportion of participants with at least one serious AE assessed as related to study product by the site investigator of record through 16 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI). | Cohort 1 Evaluable: Cohort 1 participants who were treated exclusively on the dose being evaluated for a given cohort, and either (1) completed all treatment regimen through Cohort 1 Week 16 and completed the Week 16 visit or (2) experienced any of the following: death attributable to the study product; study product-related Grade 3 or higher event (excluding injection site adverse events); OR permanently discontinued from treatment due to study product-related toxicity (regardless of grade) | Posted | Number | 95% Confidence Interval | proportion of participants | Cohort 1 Treatment Initiation through Week 16 |
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| Primary | Proportion of Participants Who Permanently Discontinued Study Product Due to Adverse Events Assessed as Related to Study Product/s (Cohort 1) | We present the proportion of participants who permanently discontinued study product due to adverse events (AEs) assessed as related to study product by the site investigator of record through 16 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI). | Cohort 1 Evaluable: Cohort 1 participants who were treated exclusively on the dose being evaluated for a given cohort, and either (1) completed all treatment regimen through Cohort 1 Week 16 and completed the Week 16 visit or (2) experienced any of the following: death attributable to the study product; study product-related Grade 3 or higher event (excluding injection site adverse events); OR permanently discontinued from treatment due to study product-related toxicity (regardless of grade) | Posted | Number | 95% Confidence Interval | proportion of participants | Cohort 1 Treatment Initiation through Week 16 |
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| Primary | Proportion of Participants Who Died Due to Adverse Events Assessed as Related to Study Product/s (Cohort 1) | We present the proportion of participants who died due to adverse events assessed as related to study product by the site investigator of record through 16 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI). | Cohort 1 Evaluable: Cohort 1 participants who were treated exclusively on the dose being evaluated for a given cohort, and either (1) completed all treatment regimen through Cohort 1 Week 16 and completed the Week 16 visit or (2) experienced any of the following: death attributable to the study product; study product-related Grade 3 or higher event (excluding injection site adverse events); OR permanently discontinued from treatment due to study product-related toxicity (regardless of grade) | Posted | Number | 95% Confidence Interval | proportion of participants | Cohort 1 Treatment Initiation through Week 16 |
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| Primary | Proportion of Participants Who Had Grade 3 or Higher Adverse Events (Cohort 2) | Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI). | Cohort 2 Naive Evaluable: Cohort 2 participants who did not participate in Cohort 1, were treated exclusively on the final recommended dose for Cohort 2, and either (1) completed all treatment regimens through Week 24 visit or (2) experienced any of the following: death attributable to the study product(s); study product(s)-related Grade 3 or higher event (excluding ISR AEs); OR permanently discontinued from treatment due to study product(s)-related toxicity during the dose-finding period. | Posted | Number | 95% Confidence Interval | proportion of participants | Cohort 2 Treatment Initiation through Week 24 |
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| Primary | Proportion of Participants Who Had Grade 3 or Higher Adverse Events Assessed as Related to Study Product/s (Cohort 2) | Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE assessed as related to study product by the site investigator of record through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI). | Cohort 2 Naive Evaluable: Cohort 2 participants who did not participate in Cohort 1, were treated exclusively on the final recommended dose for Cohort 2, and either (1) completed all treatment regimens through Week 24 visit or (2) experienced any of the following: death attributable to the study product(s); study product(s)-related Grade 3 or higher event (excluding ISR AEs); OR permanently discontinued from treatment due to study product(s)-related toxicity during the dose-finding period. | Posted | Number | 95% Confidence Interval | proportion of participants | Cohort 2 Treatment Initiation through Week 24 |
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| Primary | Proportion of Participants Who Had Serious Adverse Events Meeting ICH Criteria Assessed as Related to Study Product/s (Cohort 2) | Adverse events (AE) were assessed as a Serious AE by ICH criteria. Per ICH, a serious AE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect (see references for additional details). We present the proportion of participants with at least one serious AE assessed as related to study product by the site investigator of record through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI). | Cohort 2 Naive Evaluable: Cohort 2 participants who did not participate in Cohort 1, were treated exclusively on the final recommended dose for Cohort 2, and either (1) completed all treatment regimens through Week 24 visit or (2) experienced any of the following: death attributable to the study product(s); study product(s)-related Grade 3 or higher event (excluding ISR AEs); OR permanently discontinued from treatment due to study product(s)-related toxicity during the dose-finding period. | Posted | Number | 95% Confidence Interval | proportion of participants | Cohort 2 Treatment Initiation through Week 24 |
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| Primary | Proportion of Participants Who Permanently Discontinued Study Product Due to Adverse Events Assessed as Related to Study Product/s (Cohort 2) | We present the proportion of participants who permanently discontinued study product due to adverse events (AEs) assessed as related to study product by the site investigator of record through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI). | Cohort 2 Naive Evaluable: Cohort 2 participants who did not participate in Cohort 1, were treated exclusively on the final recommended dose for Cohort 2, and either (1) completed all treatment regimens through Week 24 visit or (2) experienced any of the following: death attributable to the study product(s); study product(s)-related Grade 3 or higher event (excluding ISR AEs); OR permanently discontinued from treatment due to study product(s)-related toxicity during the dose-finding period. | Posted | Number | 95% Confidence Interval | proportion of participants | Cohort 2 Treatment Initiation through Week 24 |
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| Primary | Proportion of Participants Who Died Due to Adverse Events Assessed as Related to Study Product/s (Cohort 2) | We present the proportion of participants who died due to adverse events assessed as related to study product by the site investigator of record through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI). | Cohort 2 Naive Evaluable: Cohort 2 participants who did not participate in Cohort 1, were treated exclusively on the final recommended dose for Cohort 2, and either (1) completed all treatment regimens through Week 24 visit or (2) experienced any of the following: death attributable to the study product(s); study product(s)-related Grade 3 or higher event (excluding ISR AEs); OR permanently discontinued from treatment due to study product(s)-related toxicity during the dose-finding period. | Posted | Number | 95% Confidence Interval | proportion of participants | Cohort 2 Treatment Initiation through Week 24 |
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| Primary | Geometric Mean Area Under the Plasma Concentration-time Curve (AUC) for Step 1 Oral CAB (Cohort 1C) | AUC calculated using non-compartmental methods with linear up-log down trapezoidal rule (Phoenix WinNonlin v 8.3, Certara®). We present the geometric mean of the AUC with associated geometric coefficient of variation. | Cohort 1 All Treated: Cohort 1 participants who have taken at least 1 dose of any study product on Cohort 1 and had an available AUC measurement | Posted | Geometric Mean | Geometric Coefficient of Variation | (h*ug)/mL | Week 2: Samples collected pre-dose and 1, 2, 3, 4, 8, and (for Q4W dosing) 24 hours post-dose |
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| Primary | Apparent Total Body Clearance (CL/F) of Step 1 Oral CAB (Cohort 1C) | We present the geometric mean of the total body clearance of CAB and associated geometric coefficient of variation, based on analysis of intensive pharmacokinetic (PK) samples. | Cohort 1 All Treated: Cohort 1 participants who have taken at least 1 dose of any study product on Cohort 1 and have an available total body clearance measurement | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/h | Week 2: Samples collected pre-dose and 1, 2, 3, 4, 8 and (for Q4W dosing) 24 hours post-dose |
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| Primary | Geometric Mean Maximum Plasma Concentration (Cmax) of Oral CAB (Cohort 1C) | We present the geometric mean of the maximum plasma concentration of CAB and associated geometric coefficient of variation, based on analysis of intensive PK samples | Cohort 1 All Treated: Cohort 1 participants who have taken at least 1 dose of any study product on Cohort 1 with an available Cmax measurement | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | Week 2: Samples collected pre-dose and 1, 2, 3, 4, 8 and (for Q4W dosing) 24 hours post-dose |
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| Primary | Time of Maximum Concentration (Tmax) of Oral CAB (Cohort 1C) | We present the mean time of maximum concentration of CAB and associated standard deviation, based on analysis of intensive PK samples. | Cohort 1 All Treated: Cohort 1 participants who have taken at least 1 dose of any study product on Cohort 1 with an available Tmax measurement | Posted | Mean | Standard Deviation | h | Week 2: Samples collected pre-dose and 1, 2, 3, 4, 8, and (for Q4W dosing) 24 hours post-dose |
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| Primary | Geometric Mean Pre-dose Concentration (C0) of Oral CAB (Cohort 1C) | We present the geometric mean pre-dose CAB concentration and associated geometric coefficient of variation, based on analysis of intensive PK samples. | Cohort 1 All Treated: Cohort 1 participants who have taken at least 1 dose of any study product on Cohort 1 with an available pre-dose concentration measurement | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | Week 2: Samples collected pre-dose and 1, 2, 3, 4, 8, and (for Q4W dosing) 24 hours post-dose |
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| Primary | Geometric Mean Concentration of LA CAB/LA RPV at Week 16 (Cohort 1 Q4W) | We present the geometric mean concentration of LA CAB/LA RPV and associated geometric coefficients of variation for participants on the Q4W dosing regimen, based on analysis of pre-dose PK sample. | Cohort 1 Q4W: Cohort 1 participants who received the Q4W dosing regimen on Cohort 1 | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | Week 16 |
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| Primary | Geometric Mean Maximum Plasma Concentration (Cmax) of LA CAB/LA RPV (Cohort 1 Q4W) | We present the geometric mean of the maximum plasma concentration of LA CAB/LA RPV and associated geometric coefficient of variation for the first injection in participants on the Q4W dosing regimen, based on analysis of intensive PK samples. | Cohort 1 Q4W: Cohort 1 participants who received the Q4W dosing regimen on Cohort 1 | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | Samples collected at Weeks 4b, 5, 6, and 8 |
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| Primary | Time of Maximum Concentration (Tmax) of LA CAB/LA RPV (Cohort 1 Q4W) | We present the mean time of maximum concentration of LA CAB/LA RPV at the first injection and associated standard deviation for participants on the Q4W dosing regimen, based on analysis of intensive PK samples. | Cohort 1 participants who received the Q4W dosing regimen on Cohort 1 | Posted | Mean | Standard Deviation | h | Samples collected at Weeks 4b, 5, 6, 8 |
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| Primary | Geometric Mean Pre-dose Concentration (C0) of LA CAB/LA RPV (Cohort 1 Q4W) | We present the geometric mean pre-dose concentrations of each injection and associated geometric coefficient of variation for participants on the Q4W dosing regimen, based on analysis of pre-dose PK samples. | Cohort 1 participants who received the Q4W dosing regimen on Cohort 1. | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | Week 4b, Week 8, Week 12 |
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| Primary | Geometric Mean Concentration of LA CAB/LA RPV at Week 16 (Cohort 1 Q8W) | We present the geometric mean concentration of LA CAB/LA RPV and associated geometric coefficients of variation for participants on the Q4W dosing regimen, based on analysis of the pre-dose PK sample. | Cohort 1 participants who received the Q8W dosing regimen on Cohort 1 | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | Week 16 |
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| Primary | Geometric Mean Maximum Plasma Concentration (Cmax) of LA CAB/LA RPV (Cohort 1 Q8W) | We present the geometric mean of the maximum plasma concentration of LA CAB/LA RPV and associated geometric coefficient of variation for the first injection in participants on the Q8W dosing regimen, based on analysis of intensive PK samples. | Cohort 1 participants who received the Q8W dosing regimen on Cohort 1. | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | Samples collected at Weeks 4b, 5, and 8 |
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| Primary | Time of Maximum Concentration (Tmax) of LA CAB/LA RPV (Cohort 1 Q8W) | We present the mean time of maximum concentration of LA CAB/LA RPV at the first injection and associated standard deviation for participants on the Q8W dosing regimen, based on analysis of intensive PK samples. | Cohort 1 participants who received the Q8W dosing regimen on Cohort 1 | Posted | Mean | Standard Deviation | h | Samples collected at Weeks 4b, 5, and 8 |
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| Primary | Geometric Mean Pre-dose Concentration (C0) of LA CAB/LA RPV (Cohort 1 Q8W) | We present the geometric mean pre-dose concentration of the first injection and associated geometric coefficient of variation for participants on the Q4W dosing regimen, based on analysis of pre-dose PK samples. | We present the geometric mean pre-dose concentration of the first injection and associated coefficient of variation for participants on the Q4W dosing regimen, based on analysis of intensive PK samples. | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | Week 4b, Week 8 |
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| Secondary | Proportion of Participants With HIV-1 RNA < 50 Copies/mL (Cohort 1) | We present the proportion of participants with results of HIV-1 RNA < 50 copies/mL at Week 16 | Cohort 1 All Treated: Cohort 1 participants who have taken at least 1 dose of any study product on Cohort 1 | Posted | Number | proportion of participants | Week 16 |
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| Secondary | Proportion of Participants Who Reported "Hurts Whole Lot" or "Hurts Worst" in Regards to Being Bothered by Pain During Injection of CAB LA or RPV LA (Cohort 1) | Results collected via administration of Pain During Injection survey to participants after receiving injection. Pain during injections was assessed using the Faces Pain Scale-Revised which includes 6 visual and text options: "no hurt," "hurts little bit," "hurts little more," "hurts even more," "hurts whole lot" and "hurts worst". | Cohort 1 All Treated: Cohort 1 participants who have taken at least 1 dose of any study product on Cohort 1 | Posted | Number | proportion of participants | Week 8 |
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| Secondary | Median Dimension of Quality of Life Scores | A commonly used 23-item Pediatric Quality of Life Inventory, the PedsQLTM, was used to measure physical, emotional, and social dimensions of health as well as school functioning. Question responses were used to generate scores from 0-100 (100 being the best quality of life) based on the PedsQLTM guidelines. The number of participants drops slightly for the school functioning result as not all participants are eligible to answer these school-related questions. | Cohort 1 All Treated: Cohort 1 participants who have taken at least 1 dose of any study product on Cohort 1 | Posted | Median | Inter-Quartile Range | score on a scale | Week 16 |
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| Secondary | Proportion of Participants Who Had Grade 3 or Higher Adverse Events (Cohort 2) | Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE through 48 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI). | Cohort 2 Naive Evaluable: Cohort 2 participants who did not participate in Cohort 1, were treated exclusively on the final recommended dose for Cohort 2, and either (1) completed all treatment regimens through Week 48 visit or (2) experienced any of the following: death attributable to the study product(s); study product(s)-related Grade 3 or higher event (excluding ISR AEs); OR permanently discontinued from treatment due to study product(s)-related toxicity during the treatment period. | Posted | Number | 95% Confidence Interval | proportion of participants | Cohort 2 treatment initiation through Week 48 |
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| Secondary | Proportion of Participants Who Had Grade 3 or Higher Adverse Events Assessed as Related to Study Product/s (Cohort 2) | Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE assessed as related to study product by the site investigator of record through 48 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI). | Cohort 2 Naive Evaluable: Cohort 2 participants who did not participate in Cohort 1, were treated exclusively on the final recommended dose for Cohort 2, and either (1) completed all treatment regimens through Week 48 visit or (2) experienced any of the following: death attributable to the study product(s); study product(s)-related Grade 3 or higher event (excluding ISR AEs); OR permanently discontinued from treatment due to study product(s)-related toxicity during the treatment period. | Posted | Number | 95% Confidence Interval | proportion of participants | Cohort 2 treatment initiation through Week 48 |
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| Secondary | Proportion of Participants Who Had Serious Adverse Events Meeting ICH Criteria, as Cited in References, Assessed as Related to Study Product/s (Cohort 2) | Adverse events (AE) were assessed as a Serious AE by ICH criteria. Per ICH, a serious AE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect (see references for additional details). We present the proportion of participants with at least one serious AE assessed as related to study product by the site investigator of record through 48 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI). | Cohort 2 Naive Evaluable: Cohort 2 participants who did not participate in Cohort 1, were treated exclusively on the final recommended dose for Cohort 2, and either (1) completed all treatment regimens through Week 48 visit or (2) experienced any of the following: death attributable to the study product(s); study product(s)-related Grade 3 or higher event (excluding ISR AEs); OR permanently discontinued from treatment due to study product(s)-related toxicity during the treatment period. | Posted | Number | 95% Confidence Interval | proportion of participants | Cohort 2 treatment initiation through Week 48 |
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| Secondary | Proportion of Participants Who Permanently Discontinued Study Product Due to Adverse Events Assessed as Related to Study Product/s (Cohort 2) | We present the proportion of participants who permanently discontinued study product due to adverse events (AEs) assessed as related to study product by the site investigator of record through 48 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI). | Cohort 2 Naive Evaluable: Cohort 2 participants who did not participate in Cohort 1, were treated exclusively on the final recommended dose for Cohort 2, and either (1) completed all treatment regimens through Week 48 visit or (2) experienced any of the following: death attributable to the study product(s); study product(s)-related Grade 3 or higher event (excluding ISR AEs); OR permanently discontinued from treatment due to study product(s)-related toxicity during the treatment period. | Posted | Number | 95% Confidence Interval | proportion of participants | Cohort 2 treatment initiation through Week 48 |
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| Secondary | Proportion of Participants Who Died Due to Adverse Events Assessed as Related to Study Product/s (Cohort 2) | We present the proportion of participants who died due to adverse events assessed as related to study product by the site investigator of record through 48 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI). | Cohort 2 Naive Evaluable: Cohort 2 participants who did not participate in Cohort 1, were treated exclusively on the final recommended dose for Cohort 2, and either (1) completed all treatment regimens through Week 48 visit or (2) experienced any of the following: death attributable to the study product(s); study product(s)-related Grade 3 or higher event (excluding ISR AEs); OR permanently discontinued from treatment due to study product(s)-related toxicity during the treatment period. | Posted | Number | 95% Confidence Interval | proportion of participants | Cohort 2 treatment initiation through Week 48 |
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| Secondary | Proportion of Participants With Plasma HIV-1 RNA >= 50 Copies/mL Per the FDA Snapshot (Cohort 2) | We present the proportion of participants with HIV-1 RNA >= 50 copies/mL and associated exact 95% CI (Clopper-Pearson) per the FDA snapshot, based on laboratory evaluations. | Cohort 2 Naive Evaluable: Cohort 2 participants who did not participate in Cohort 1, were treated exclusively on the final recommended dose for Cohort 2, and either (1) completed all treatment regimens through Week 24 visit or (2) experienced any of the following: death attributable to the study product(s); study product(s)-related Grade 3 or higher event (excluding ISR AEs); OR permanently discontinued from treatment due to study product(s)-related toxicity during the treatment period | Posted | Number | 95% Confidence Interval | proportion of participants | Week 24 |
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| Secondary | Proportion of Participants With Plasma HIV-1 RNA >= 200 Copies/mL Per the FDA Snapshot (Cohort 2) | We present the proportion of participants with HIV-1 RNA >= 200 copies/mL and associated exact 95% CI (Clopper-Pearson) per the FDA snapshot, based on laboratory evaluations. | Cohort 2 Naive Evaluable: Cohort 2 participants who did not participate in Cohort 1, were treated exclusively on the final recommended dose for Cohort 2, and either (1) completed all treatment regimens through Week 24 visit or (2) experienced any of the following: death attributable to the study product(s); study product(s)-related Grade 3 or higher event (excluding ISR AEs); OR permanently discontinued from treatment due to study product(s)-related toxicity during the treatment period | Posted | Number | 95% Confidence Interval | proportion of participants | Week 24 |
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| Secondary | Proportion of Participants With Plasma HIV-1 RNA >= 50 Copies/mL Per the FDA Snapshot (Cohort 2) | We present the proportion of participants with HIV-1 RNA >= 50 copies/mL and associated exact 95% CI (Clopper-Pearson) per the FDA snapshot, based on laboratory evaluations. | Cohort 2 Naive Evaluable: Cohort 2 participants who did not participate in Cohort 1, were treated exclusively on the final recommended dose for Cohort 2, and either (1) completed all treatment regimens through Week 48 visit or (2) experienced any of the following: death attributable to the study product(s); study product(s)-related Grade 3 or higher event (excluding ISR AEs); OR permanently discontinued from treatment due to study product(s)-related toxicity during the treatment period | Posted | Number | 95% Confidence Interval | proportion of participants | Week 48 |
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| Secondary | Proportion of Participants With Plasma HIV-1 RNA >= 200 Copies/mL Per the FDA Snapshot (Cohort 2) | We present the proportion of participants with HIV-1 RNA >= 200 copies/mL and associated exact 95% CI (Clopper-Pearson) per the FDA snapshot, based on laboratory evaluations. | Cohort 2 Naive Evaluable: Cohort 2 participants who did not participate in Cohort 1, were treated exclusively on the final recommended dose for Cohort 2, and either (1) completed all treatment regimens through Week 48 visit or (2) experienced any of the following: death attributable to the study product(s); study product(s)-related Grade 3 or higher event (excluding ISR AEs); OR permanently discontinued from treatment due to study product(s)-related toxicity during the treatment period | Posted | Number | 95% Confidence Interval | proportion of participants | Week 48 |
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| Secondary | Geometric Mean Pre-dose Concentration (C0) of Oral CAB and Oral RPV (Cohort 2) | We present the geometric mean of the pre-dose concentration of oral CAB and oral RPV and associated coefficient of variation, based on analysis of pre-dose PK sample. | Cohort 2 All Treated: Cohort 2 participants who have taken at least 1 dose of any study product on Cohort 2 | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | Week 2 |
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| Secondary | Geometric Mean Ratio of Pre-dose CAB and RPV Concentrations at Week 24: Pre-dose CAB and RPV Concentrations at Week 8 (Cohort 2) | We present the geometric mean of the ratios of pre-dose CAB and RPV concentrations at Week 24:Week 8 and associated coefficient of variation, based on analysis of pre-dose PK samples. | Cohort 2 All Treated: Cohort 2 participants who have taken at least 1 dose of any study product on Cohort 2 | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | Week 8 and Week 24 |
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| Secondary | Geometric Mean Ratio of Pre-dose CAB and RPV Concentrations at Week 24: Pre-dose CAB and RPV Concentrations at Week 16 (Cohort 2) | We present the geometric mean of the ratios of pre-dose CAB and RPV concentrations at Week 24:Week 16 and associated coefficient of variation, based on analysis of pre-dose PK samples. | Cohort 2 All Treated: Cohort 2 participants who have taken at least 1 dose of any study product on Cohort 2 | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | Week 16 and Week 24 |
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| Secondary | Geometric Mean Ratio of Pre-dose CAB and RPV Concentrations at Week 48: Pre-dose CAB and RPV Concentrations at Week 8 (Cohort 2) | We present the geometric mean of the ratios of pre-dose CAB and RPV concentrations at Week 48:Week 8 and associated coefficient of variation, based on analysis of pre-dose PK samples. | Cohort 2 All Treated: Cohort 2 participants who have taken at least 1 dose of any study product on Cohort 2 | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | Week 8 and Week 48 |
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| Secondary | Geometric Mean Ratio of Pre-dose CAB and RPV Concentrations at Week 48: Pre-dose CAB and RPV Concentrations at Week 16 (Cohort 2) | We present the geometric mean of the ratios of pre-dose CAB and RPV concentrations at Week 48:Week 16 and associated coefficient of variation, based on analysis of pre-dose PK samples. | Cohort 2 All Treated: Cohort 2 participants who have taken at least 1 dose of any study product on Cohort 2 | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | Week 16 and Week 48 |
|
|
Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1C: CAB | Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks. Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12). Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8). Oral Cabotegravir (CAB): 30 mg tablets administered orally Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study. | 0 | 30 | 1 | 30 | 28 | 30 |
| EG001 | Cohort 1R: RPV | Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks. Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12). Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8). Oral Rilpivirine (RPV): 25 mg tablets administered orally Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study. | 0 | 25 | 0 | 25 | 23 | 25 |
| EG002 | Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA | Step 3: CAB administered orally as one 30 mg tablet once daily and RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit for 4-6 weeks. Step 4: First and second injections: CAB LA administered as a 600 mg IM injection and RPV LA administered as a 900 mg IM injection at Week 4b and at Week 8. Subsequent injections: starting at Week 16, CAB LA administered as a 600 mg IM injection and RPV LA administered as a 900 mg IM injection every eight weeks through Week 96 or final safety extension visit. Oral Cabotegravir (CAB): 30 mg tablets administered orally Oral Rilpivirine (RPV): 25 mg tablets administered orally Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection | 0 | 144 | 9 | 144 | 136 | 144 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Gastritis alcoholic haemorrhagic | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Malaria | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Typhoid fever | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cephalo-pelvic disproportion | Pregnancy, puerperium and perinatal conditions | MedDRA 28.0 | Systematic Assessment |
| |
| Prolonged labour | Pregnancy, puerperium and perinatal conditions | MedDRA 28.0 | Systematic Assessment |
| |
| Umbilical cord around neck | Pregnancy, puerperium and perinatal conditions | MedDRA 28.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Normocytic anaemia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Sickle cell trait | Congenital, familial and genetic disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Ear canal erythema | Ear and labyrinth disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Ear pruritus | Ear and labyrinth disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Middle ear effusion | Ear and labyrinth disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Motion sickness | Ear and labyrinth disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Noninfective myringitis | Ear and labyrinth disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Otorrhoea | Ear and labyrinth disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Tympanic membrane disorder | Ear and labyrinth disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Autoimmune thyroiditis | Endocrine disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Conjunctival pallor | Eye disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Eye discharge | Eye disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Ocular discomfort | Eye disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Breath odour | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Enlarged uvula | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Lip dry | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Malpositioned teeth | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Oral mucosal erythema | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Tongue ulceration | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Tooth impacted | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Complication of device insertion | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Immediate post-injection reaction | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Injection site hypoaesthesia | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Injection site joint pain | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Injection site nodule | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Medical device pain | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Mucosal discolouration | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Mucosal disorder | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Mucosal hyperaemia | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nodule | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Suprapubic pain | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Swelling face | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Vaccination site pain | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Vessel puncture site pain | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Ocular icterus | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Body tinea | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Dermatophytosis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Enterocolitis viral | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Genital herpes | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Herpes simplex pharyngitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Injection site abscess | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Latent syphilis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Malaria | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Mumps | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Pelvic inflammatory disease | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Plasmodium falciparum infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Proctitis gonococcal | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Scabies | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Secondary syphilis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Skin bacterial infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Skin candida | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Syphilis genital | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Tinea infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Tinea versicolour | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Typhoid fever | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Urethritis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Urethritis gonococcal | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Viral pharyngitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Adverse event following immunisation | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Incision site pain | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Injection related reaction | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Perineal injury | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Post procedural inflammation | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Product administration error | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Scar | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Stab wound | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Traumatic pain | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Wound secretion | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood pressure diastolic increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood pressure systolic increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Breath sounds abnormal | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Electrocardiogram PR prolongation | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Glomerular filtration rate decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Low density lipoprotein increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Abnormal loss of weight | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Overweight | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Underweight | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Coccydynia | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Tendon pain | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Torticollis | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Fibroadenoma of breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.0 | Systematic Assessment |
| |
| Pyogenic granuloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.0 | Systematic Assessment |
| |
| Delayed sleep phase | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Sleep paralysis | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Speech disorder | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Attention deficit hyperactivity disorder | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Post-traumatic stress disorder | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Stress | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Glycosuria | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Abnormal uterine bleeding | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Adnexa uteri mass | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Amenorrhoea | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Breast discharge | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Breast mass | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Breast swelling | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Breast tenderness | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Heavy menstrual bleeding | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Menstruation irregular | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Penile pain | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Perineal pain | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Increased upper airway secretion | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Lung hypoinflation | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nasal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nasal mucosal discolouration | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nasal mucosal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nasal mucosal hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nasal pruritus | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Sinus pain | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Snoring | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Tonsillar erythema | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Tonsillar inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dilated pores | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Papule | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Physical assault | Social circumstances | MedDRA 28.0 | Systematic Assessment |
| |
| Sexual abuse | Social circumstances | MedDRA 28.0 | Systematic Assessment |
| |
| Substance use | Social circumstances | MedDRA 28.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pallor | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Systolic hypertension | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
|
In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| IMPAACT ClinicalTrials.gov Coordinator | Family Health International (FHI 360) | (919) 405-1429 | IMPAACT.ctgov@fstrf.org |
| Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: V3.0 | Aug 13, 2020 | Feb 7, 2024 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: V2.0 | Sep 3, 2020 | Jan 22, 2024 | SAP_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: V3.1 | Aug 25, 2023 | Jan 22, 2024 | SAP_003.pdf |
Not provided
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C584914 | cabotegravir |
| D000068696 | Rilpivirine |
| D023241 | Antiretroviral Therapy, Highly Active |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004359 | Drug Therapy, Combination |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
| Withdrawal by Subject |
|
| Protocol Violation |
|
| Non-compliance with study treatment |
|
| Adverse Event |
|
|
| Cohort 2 |
|
|
|
| Cohort 2 |
|
|
|
| Cohort 2 |
|
|
|
| Cohort 2 |
|
|
|
| Cohort 2 |
|
|
|
| Cohort 2 |
|
|
|
| Cohort 2 |
|
|
|
| Cohort 1 Emotional Functioning Dimension |
|
|
| Cohort 1 Social Functioning Dimension |
|
|
| Cohort 1 School Functioning Dimension |
|
|
| Cohort 1 Psychosocial Functioning Dimension |
|
|
| Cohort 1 Total Functioning Dimension |
|
|
| Cohort 2 Physical Functioning |
|
|
| Cohort 2 Emotional Functioning Dimension |
|
|
| Cohort 2 Social Functioning Dimension |
|
|
| Cohort 2 School Functioning Dimension |
|
|
| Cohort 2 Psychosocial Functioning |
|
|
| Cohort 2 Total Functioning |
|
|
|
|
|
|
|
|
|
|
| OG001 | Cohort 1R: RPV | Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks. Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12). Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8). Oral Rilpivirine (RPV): 25 mg tablets administered orally Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study. |
|
|
| OG001 | Cohort 1R: RPV | Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks. Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12). Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8). Oral Rilpivirine (RPV): 25 mg tablets administered orally Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study. |
|
|
| OG001 | Cohort 1R: RPV | Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks. Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12). Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8). Oral Rilpivirine (RPV): 25 mg tablets administered orally Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study. |
|
|
| OG001 | Cohort 1R: RPV | Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks. Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12). Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8). Oral Rilpivirine (RPV): 25 mg tablets administered orally Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study. |
|
|
| OG001 | Cohort 1R: RPV | Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks. Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12). Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8). Oral Rilpivirine (RPV): 25 mg tablets administered orally Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study. |
|
|
|
|
|
|
|
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
|
|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks. Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12). Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8). Oral Rilpivirine (RPV): 25 mg tablets administered orally Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study. |
|
|
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks. Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12). Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8). Oral Rilpivirine (RPV): 25 mg tablets administered orally Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| 14 |
|
| 15 |
|
| 16 |
|
| 17 |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| South Africa |
|
| Uganda |
|
| Thailand |
|