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| ID | Type | Description | Link |
|---|---|---|---|
| 38654 | Registry Identifier | DAIDS ES |
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This study will establish the minimum safety, tolerability and acceptability data needed to support the use of cabotegravir long-acting injection (CAB LA) in an adolescent population, potentially transforming the field of HIV prevention for young people.
The purpose of this study is to establish the minimum safety, tolerability and acceptability data needed to support the use of cabotegravir long-acting injection (CAB LA) in an adolescent population, potentially transforming the field of HIV prevention for young people.
This study will enroll healthy, HIV-uninfected adolescents assigned male at birth, including men who have sex with men (MSM), transgender women (TGW), and gender non-conforming people. The total participant commitment for the entire study is approximately 1.5 years.
This study will take place in three steps. In Step 1, participants will receive daily oral CAB tablets for 5 weeks. In Step 2, participants will receive a series of five intramuscular (IM) injections of CAB LA, administered at 8-week intervals after a 4-week loading dose (injections at Weeks 5, 9, 17, 25 & 33). A safety visit will follow each injection to ascertain safety data, including injection site reactions. In Step 3, all participants who have received at least one injection will be followed quarterly (every 3 months) for 48 weeks after their last injection. Participants will receive oral TDF/FTC for daily use for 48 weeks or may be provided the opportunity to enroll in a local open label study of CAB, if available.
Participants will attend about 18 study visits throughout the study. Visits may include physical examinations, blood collection, urine collection, rectal and oral pharyngeal swab collection, risk reduction and adherence counseling, and behavioral or acceptability assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAB LA | Experimental | In Step 1, participants will receive one CAB tablet orally every day for 5 weeks. In Step 2, participants will receive an intramuscular (IM) injection of CAB LA at Weeks 5, 9, 17, 25, and 33. In Step 3, participants will receive a TDF/FTC tablet orally every day for 48 weeks or may be offered the opportunity to join an open label CAB study instead, if such a study is being implemented in their area at the time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cabotegravir (CAB) tablet | Drug | 30 mg tablets |
| |
| CAB LA |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoint: Proportion of Participants Experiencing Any Grade 2 or Higher Clinical Adverse Events (AEs) and Laboratory Abnormalities Among Participants Who Receive at Least One Injection of CAB LA. | Number and percent of participants experiencing any Grade 2 or higher clinical adverse events (AEs) or laboratory abnormalities (reported as adverse events) from the first injection visit to 8 weeks after the last Step 2 injection visit, or Week 41, whichever comes first. | Measured through participant's first injection visit up to 8 weeks after the last Step 2 injection visit or Week 41, whichever comes first. |
| Tolerability Endpoint: Proportion of Participants Who Receive at Least 1 Injection and Who Discontinue Receiving Injections Prior to the Full Course of Injections Due to Intolerability of Injection, Frequency of Injections or Burden of Study Procedures. | Number and percent of participants who receive at least 1 injection and who discontinue receiving injections prior to the full course of injections due to intolerability of injection or burden of study procedures. Reasons for intolerability may include:
| Measured through participant's first injection visit up to 8 weeks after the last Step 2 injection visit or Week 41, whichever comes first. |
| Acceptability Endpoint: Proportion of Participants Who Complete All Scheduled Injections and Proportion of Participants Who Receive at Least One Injection Whom Would Consider Using CAB LA for HIV Prevention in the Future. | Definition of completing all scheduled injections for participants who are confirmed HIV positive or discontinue product due to the following reasons:
During Step 2: Both enrolled and injection populations: completed all injections whose target window closed prior to death/seroconversion/product discontinuation date | Measured through participant's first injection visit up to 8 weeks after the last Step 2 injection visit or Week 41, whichever comes first. |
| Measure | Description | Time Frame |
|---|---|---|
| Count of Participant-study Visits Above the Protein-adjusted Inhibitor Concentration (90%; PA-IC90) | CAB drug concentrations will be measured in plasma to generate CAB-LA concentration-time profiles among study participants. Measurements will occur at study visits during the injection phase of the study as well as during the pharmacologic "tail" phase. Count of participants for injection visits in which a participant remains above the 1x (0.166 mcg/mL), 4x (0.664 mcg/mL) and 8x (1.33 mcg/mL) PA-IC90.Concentrations above the 3 PA-IC90 are associated with rectal protection in a non-human primate study, and concentrations above the 8x PA-IC90 are expected to be associated with protection in humans. |
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Inclusion Criteria:
Assigned male at birth (includes MSM, TGW, and gender non-conforming people)
At enrollment, aged below 18 years
At enrollment, body weight ≥ 35 kg (77 lbs.)
Willing to provide informed consent for the study
Self-reported sexual activity with a male in the past 12 months
In general, good health, as evidenced by the following laboratory values
Willing to undergo all required study procedures
If currently on pre-exposure prophylaxis (PrEP) from a non-study source, willing to stop said PrEP prior to enrollment and agree to switch to oral CAB for the lead-in period and CAB LA injections.
Exclusion Criteria:
Assigned male at birth (includes MSM, TGW, and gender non-conforming people)
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| Name | Affiliation | Role |
|---|---|---|
| Sybil Hosek, PhD | Stroger Hospital of Cook County | Study Chair |
| Lynda Stranix-Chibanda, MBChB, MMED | University of Zimbabwe College of Health Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver ATN CRS | Aurora | Colorado | 80045 | United States | ||
| John H. Stroger Jr. Hosp. of Cook County ATN CRS |
A total of 9 participants were eligible and enrolled. The Study has 3 steps, Oral CAB, Injection CAB LA and the Follow-up of Injection CAB with use of TDF/FTC, Truvada® for daily use or continued CAB injections for 48 weeks.
One participant terminated before the end of Step 2 "Withdrawal by Subject". Of the 8 remaining participants, one participant "Scheduled exit visit/end of study" prior to the start of Step 3. Within Step 3, one participant switched from TDF/FTC to Injection CAB LA.
The study will be targeted towards at-risk, sexually active adolescent populations of MSM in the US. Enrollment will occur over approximately 18 months.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cabotegravir Long Acting | In Step 1, participants will receive one CAB tablet orally every day for 5 weeks. In Step 2, participants will receive an intramuscular (IM) injection of CAB LA at Weeks 5, 9, 17, 25, and 33. In Step 3, participants will receive a TDF/FTC tablet orally every day for 48 weeks or may be offered the opportunity to join an open label CAB study instead, if such a study is being implemented in their area at the time. Cabotegravir (CAB) tablet: 30 mg tablets CAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter. Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) tablet: 300 mg/200 mg fixed-dose combination tablets |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Cabotegravir Long Acting Oral Phase |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Jul 2, 2021 |
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| Drug |
Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter. |
|
| Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) tablet | Drug | 300 mg/200 mg fixed-dose combination tablets |
|
| Measured from the participant's first injection visit up to 8 weeks after the last Step 2 injection visit or Week 41 |
| Measure Study Product Concentrations in Enrolled Participants With HPTN Laboratory Center (LC) Confirmed HIV Infection Throughout Study. | For infections occurring prior to (or on the first day of) Step 3, we will include visit level plasma CAB concentrations, for individual seroconverters. For infections occurring after the start of Step 3, we will include visit level plasma CAB concentrations as well as concentrations of TFV and TFV-DP (if applicable). | Measured through seroconverter's first Oral visit up through end of study participation (step1, 2, 3) |
| Count and Percentage of Participants Experiencing Grade 2 or Higher Clinical AEs and LaboratoryAbnormalities in the Oral Phase and the Aggregate Oral and Injection Phases | Number and percent of participants experiencing any Grade 2 or higher clinical adverse events (AEs) or laboratory abnormalities from:
| Measured through participant's first oral visit up to 8 weeks after the last Step 2 injection visit or Week 41, whichever comes first. |
| Proportion of Participants Receiving One or More Injections Who Experience Grade 2 or Higher Clinical AEs and Laboratory Abnormalities From Initial Injection to 36 Weeks Later. | Number and percent of participants experiencing any Grade 2 or higher clinical adverse events (AEs) or laboratory abnormalities from the first injection visit to approximately 36 weeks later regardless of whether participants received all 5 injections. | Measured through participant's first injection visit up to 8 weeks after the last Step 2 injection visit or Week 41, whichever comes first. |
| Proportion of Injection Visits That Occurred "On-time". | Number and percentage of injections given, using the number of injections expected as the denominator. while the number and percent of injection visits (up to 5 per participant) that occur "on-time", using the number of injections given as the denominator. This will be presented along with the total number and percent of injections given, among all intended injections (i.e. 5 injections per participant). Those who have been terminated, are HIV infected, or have permanently discontinued study products at the time of visit will be excluded from the number of expected injections. | Measured through participant's last step 2 injection. |
| Change From Enrollment of Self-reported Sexual Behavior (Number of Sexual Partners) During the Study Period | Counts of sexual partners will be summarized (mean and sd) at enrollment and each regular Step 1 and Step 2 follow-up visit (W4, W5, W9, W17, W25, W33). | Measured through participant's first oral visit up to last Step 2 injection visit. |
| Change From Enrollment of Self-reported Sexual Behavior (Number of Episodes of Anal Intercourse Without a Condom) During the Study Period | Counts of episodes of anal intercourse without a condom will be summarized (mean and sd) at enrollment and each regular Step 1 and Step 2 follow-up visit (W4, W5, W9, W17, W25, W33). | Measured through participant's first oral visit up to the last Step 2 injection visit. |
| Evaluate Rates of HIV Drug Resistance Among Participants Who Acquire HIV Infection During the Study | Data from steps 1, 2, and 3 will be included. The number of cases of drug resistance will be summarized. All cases of drug resistance among incident HIV infections will be described. | Measured through participant's last study visit, up to approximately 1.5 years after study entry. |
| Chicago |
| Illinois |
| 60612 |
| United States |
| The Fenway Institute ATN CRS | Boston | Massachusetts | 02215 | United States |
| St. Jude Children's Research Hosp. ATN CRS | Memphis | Tennessee | 38105 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| Cabotegravir Long Acting Injection Phase |
|
|
| Step 3 Follow-up Phase |
|
Includes all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cabotegravir Long Acting | In Step 1, participants will receive one CAB tablet orally every day for 5 weeks. In Step 2, participants will receive an intramuscular (IM) injection of CAB LA at Weeks 5, 9, 17, 25, and 33. In Step 3, participants will receive a TDF/FTC tablet orally every day for 48 weeks or may be offered the opportunity to join an open label CAB study instead, if such a study is being implemented in their area at the time. Cabotegravir (CAB) tablet: 30 mg tablets CAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter. Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) tablet: 300 mg/200 mg fixed-dose combination tablets |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex/Gender, Customized | Self-reported Gender Identity | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Age Standardized BMI z-score Classification | Measure Description: Based on age in months. Final z-scores calculated using World Health Organization (WHO) tool (https://www.who.int/tools/growth-reference-data-for-5to19-years/indicators/bmi-for-age). Categories allocated according to the following z-scores: Obesity: > +2; Overweight: > +1 and <= +2; Normal: > -2 and <= +1; Thinness: > -3 and<= -2; Severe thinness: <= -3. | Count of Participants | Participants |
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| Do you have a regular place or home where you stay and store your things? | Count of Participants | Participants |
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| In the past 6 months, how frequently did you worry that your household would not have enough food? | Count of Participants | Participants |
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| 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 | Safety Endpoint: Proportion of Participants Experiencing Any Grade 2 or Higher Clinical Adverse Events (AEs) and Laboratory Abnormalities Among Participants Who Receive at Least One Injection of CAB LA. | Number and percent of participants experiencing any Grade 2 or higher clinical adverse events (AEs) or laboratory abnormalities (reported as adverse events) from the first injection visit to 8 weeks after the last Step 2 injection visit, or Week 41, whichever comes first. | Includes enrolled participants who receive at least one injection of CAB LA. | Posted | Count of Participants | Participants | Measured through participant's first injection visit up to 8 weeks after the last Step 2 injection visit or Week 41, whichever comes first. |
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| Primary | Tolerability Endpoint: Proportion of Participants Who Receive at Least 1 Injection and Who Discontinue Receiving Injections Prior to the Full Course of Injections Due to Intolerability of Injection, Frequency of Injections or Burden of Study Procedures. | Number and percent of participants who receive at least 1 injection and who discontinue receiving injections prior to the full course of injections due to intolerability of injection or burden of study procedures. Reasons for intolerability may include:
| Includes all enrolled participants | Posted | Count of Participants | Participants | Measured through participant's first injection visit up to 8 weeks after the last Step 2 injection visit or Week 41, whichever comes first. |
|
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| Primary | Acceptability Endpoint: Proportion of Participants Who Complete All Scheduled Injections and Proportion of Participants Who Receive at Least One Injection Whom Would Consider Using CAB LA for HIV Prevention in the Future. | Definition of completing all scheduled injections for participants who are confirmed HIV positive or discontinue product due to the following reasons:
During Step 2: Both enrolled and injection populations: completed all injections whose target window closed prior to death/seroconversion/product discontinuation date | Includes all enrolled participants and all enrolled participants who receive at least one injection of CAB LA. | Posted | Count of Participants | Participants | Measured through participant's first injection visit up to 8 weeks after the last Step 2 injection visit or Week 41, whichever comes first. |
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| Secondary | Count of Participant-study Visits Above the Protein-adjusted Inhibitor Concentration (90%; PA-IC90) | CAB drug concentrations will be measured in plasma to generate CAB-LA concentration-time profiles among study participants. Measurements will occur at study visits during the injection phase of the study as well as during the pharmacologic "tail" phase. Count of participants for injection visits in which a participant remains above the 1x (0.166 mcg/mL), 4x (0.664 mcg/mL) and 8x (1.33 mcg/mL) PA-IC90.Concentrations above the 3 PA-IC90 are associated with rectal protection in a non-human primate study, and concentrations above the 8x PA-IC90 are expected to be associated with protection in humans. | Includes enrolled participants who receive at least one injection of CAB LA. | Posted | Count of Participants | Participants | Measured from the participant's first injection visit up to 8 weeks after the last Step 2 injection visit or Week 41 |
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| Secondary | Measure Study Product Concentrations in Enrolled Participants With HPTN Laboratory Center (LC) Confirmed HIV Infection Throughout Study. | For infections occurring prior to (or on the first day of) Step 3, we will include visit level plasma CAB concentrations, for individual seroconverters. For infections occurring after the start of Step 3, we will include visit level plasma CAB concentrations as well as concentrations of TFV and TFV-DP (if applicable). | All enrolled participants who became HIV infected during the study (Step 1, 2 or 3). Serum concentrations were not collected for this measure because no participants had HPTN Laboratory Center (LC) Confirmed HIV Infection at enrollment or during Steps 1,2, and 3. | Posted | Measured through seroconverter's first Oral visit up through end of study participation (step1, 2, 3) |
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| Secondary | Count and Percentage of Participants Experiencing Grade 2 or Higher Clinical AEs and LaboratoryAbnormalities in the Oral Phase and the Aggregate Oral and Injection Phases | Number and percent of participants experiencing any Grade 2 or higher clinical adverse events (AEs) or laboratory abnormalities from:
| Includes enrolled participants who began step 1 (oral phase). | Posted | Count of Participants | Participants | Measured through participant's first oral visit up to 8 weeks after the last Step 2 injection visit or Week 41, whichever comes first. |
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| Secondary | Proportion of Participants Receiving One or More Injections Who Experience Grade 2 or Higher Clinical AEs and Laboratory Abnormalities From Initial Injection to 36 Weeks Later. | Number and percent of participants experiencing any Grade 2 or higher clinical adverse events (AEs) or laboratory abnormalities from the first injection visit to approximately 36 weeks later regardless of whether participants received all 5 injections. | Includes enrolled participants who receive at least one injection of CAB LA. | Posted | Count of Participants | Participants | Measured through participant's first injection visit up to 8 weeks after the last Step 2 injection visit or Week 41, whichever comes first. |
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| Secondary | Proportion of Injection Visits That Occurred "On-time". | Number and percentage of injections given, using the number of injections expected as the denominator. while the number and percent of injection visits (up to 5 per participant) that occur "on-time", using the number of injections given as the denominator. This will be presented along with the total number and percent of injections given, among all intended injections (i.e. 5 injections per participant). Those who have been terminated, are HIV infected, or have permanently discontinued study products at the time of visit will be excluded from the number of expected injections. | Includes enrolled participants who receive at least one injection of CAB LA. By the end of step 2, just 1/8 participants missed their last injection but continued with the study and received a step 3 injection. This participant was counted as having 100% of injections completed with 5 injections. For this analysis, through the end of Step 2, technically 1 less injection was given in this case. | Posted | Number | Number of Injections given | Measured through participant's last step 2 injection. | Number of Injections Expected | Number of Injections Expected |
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| Secondary | Change From Enrollment of Self-reported Sexual Behavior (Number of Sexual Partners) During the Study Period | Counts of sexual partners will be summarized (mean and sd) at enrollment and each regular Step 1 and Step 2 follow-up visit (W4, W5, W9, W17, W25, W33). | Includes all enrolled participants: For each visits: analysis population includes participants with non-missing value. For the difference between 2 visits: analysis population only includes participants with non-missing values for both visits. . | Posted | Mean | Standard Deviation | Number of Sexual Partners | Measured through participant's first oral visit up to last Step 2 injection visit. |
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| Secondary | Change From Enrollment of Self-reported Sexual Behavior (Number of Episodes of Anal Intercourse Without a Condom) During the Study Period | Counts of episodes of anal intercourse without a condom will be summarized (mean and sd) at enrollment and each regular Step 1 and Step 2 follow-up visit (W4, W5, W9, W17, W25, W33). | Includes all enrolled participants: For each visits: analysis population includes participants with non-missing value. For the difference between 2 visits: analysis population only includes participants with non-missing values for both visits. | Posted | Mean | Standard Deviation | Episodes of condomless anal intercourse | Measured through participant's first oral visit up to the last Step 2 injection visit. |
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| Secondary | Evaluate Rates of HIV Drug Resistance Among Participants Who Acquire HIV Infection During the Study | Data from steps 1, 2, and 3 will be included. The number of cases of drug resistance will be summarized. All cases of drug resistance among incident HIV infections will be described. | Includes all enrolled participants who seroconverted during the study. | Posted | Count of Participants | Participants | Measured through participant's last study visit, up to approximately 1.5 years after study entry. |
|
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Measured from participant's first Oral visit up to follow-up 48 weeks Step 3.
SAE, NON SAE, and Mortality are summarized by Steps (Oral, Injection & Follow-up)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Step 1 - CAB LA Oral Phase | A 5-week oral CAB 30 mg QD safety lead-in | 0 | 9 | 0 | 9 | 8 | 9 |
| EG001 | Step 2 - CAB LA Injection Phase | A series of 5 intramuscular (IM) injections of 3 mL (600 mg) cabotegravir administered at 8 week intervals after a 4-week loading dose (injections at weeks 5, 9, 17, 25 & 33) | 0 | 9 | 0 | 9 | 9 | 9 |
| EG002 | Step 3 - CAB LA Injection Follow-up | Participants who elected to receive intramuscular (IM) cabotegravir (CAB LA) injections during Step 3 follow-up. This regimen consists of 3 mL (600 mg) injections administered every 8 weeks for up to 48 weeks after their final injection in Step 2, with injections given at weeks +8, +16, +24, +32, +40, and +48. | 0 | 6 | 1 | 6 | 5 | 6 |
| EG003 | Step 3 - Tenofovir/Emtricitabine Follow-up | Participants who elected to receive daily oral Tenofovir/Emtricitabine (TDF/FTC, Truvada®) during Step 3 follow-up. This regimen consists of a 300 mg/200 mg tablet administered daily for up to 48 weeks after their final injection in Step 2, starting at the +8 week visit (then followed at weeks +12, +24, +36, and +48). Participants in Step 3 are permitted to switch from TDF/FTC to CAB LA if desired. | 0 | 3 | 0 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal ideation | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tricuspid valve incompetence | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
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| Blood calcium increased | Investigations | MedDRA 26.0 | Systematic Assessment |
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| Blood cholesterol increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood creatine increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 26.0 | Systematic Assessment |
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| Blood glucose decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
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| Blood phosphorus decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
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| Blood potassium increased | Investigations | MedDRA 26.0 | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA 26.0 | Systematic Assessment |
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| Blood triglycerides increased | Investigations | MedDRA 26.0 | Systematic Assessment |
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| Creatinine renal clearance decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
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| Lipase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
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| Low density lipoprotein increased | Investigations | MedDRA 26.0 | Systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
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| Behaviour disorder | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
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| Disruptive mood dysregulation disorder | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
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| Impulse-control disorder | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
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| Proteinuria | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| HPTN Statistical Manager | HPTN Statistical & Data Management Center | +1 (206) 667-4004 | HPTN-Data-Access@scharp.org |
| Jun 12, 2024 |
| Prot_ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 17, 2023 | Aug 28, 2024 | SAP_002.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 |
| D000068698 | Tenofovir |
| D000068679 | Emtricitabine |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Male |
|
| Self-Identify |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Normal |
|
| Thinness |
|
| Severe thinness |
|
| Often worried |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
| Number of Injections Expected |
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| >=8x PA-IC90 |
|
| >=8x PA-IC90 |
|
| >=8x PA-IC90 |
|
| >=8x PA-IC90 |
|
| >=8x PA-IC90 |
|