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| ID | Type | Description | Link |
|---|---|---|---|
| TMC278-TiDP38-C213 | Other Identifier | Janssen Sciences Ireland UC | |
| 2008-001696-30 | EudraCT Number |
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The purpose of this study is to evaluate the pharmacokinetics, safety and antiviral activity of rilpivirine (TMC278) 25 milligram (mg) or adjusted dose once daily in combination with an investigator-selected background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors (N[t]RTIs) (zidovudine [AZT], abacavir [ABC], or tenofovir disoproxil fumarate [TDF] in combination with lamivudine [3TC] or emtricitabine [FTC] in antiretroviral (ARV) treatment-naïve adolescents and children aged greater than or equal to (>=) 6 to less than (<) 18 years.
This is a Phase II, open-label (all people involved know the identity of the assigned drug) and single arm study. The study will consist of a screening period of maximum 8 weeks, an initial treatment period of 48 weeks, a post week 48 treatment extension period of 4 years (Cohort 1 only), and a 4 week follow-up (cohort 2 only) period. Participants who withdraw from the trial on or before the Week 48 visit or subjects with ongoing (serious) adverse events ([S]AEs), laboratory abnormalities, or viral load increase at the last on-treatment visit in the extension, will be seen for a follow-up visit 4 weeks later. The initial 48-week treatment period will be structured into 2 age Cohorts; Cohort 1 (Aged greater than or equal to [>=] 12 to less than [<] 18 years) and Cohort 2 (Children Aged >= 6 to < 12 years). The trial is designed to evaluate the steady-state pharmacokinetic (PK) profile (based on intensive PK analysis) and the short-term safety and antiviral activity of rilpivirine (RPV). Participants will receive RPV 25 milligram (mg), or weight-adjusted dose orally once daily for 240 weeks when administered in combination with 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs). The trial will also evaluate long-term (48 weeks and 240 weeks [Cohort 1]) safety, efficacy, and pharmacokinetics of rilpivirine in combination with the background regimen of 2 NRTIs. Patients safety will be monitored throughout the study and during the follow up visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rilpivirine (TMC278) | Experimental | The patients received rilpivirine with 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) as a background regimen in cohort 1 [aged greater than or equal to (> =) 12 to less than (<) 18 years] for up to 240 weeks which is already completed and recruitment closed and will receive this treatment in cohort 2 (children aged > = 6 to < 12 years) for up to 48 weeks. The NRTIs include zidovudine, abacavir, or tenofovir disoproxil fumarate in combination with lamivudine or emtricitabine. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rilpivirine | Drug | Patients will receive rilpivirine (RPV) tablet 25 milligram dose or an adjusted dose orally once daily in Cohort 1 (adolescents aged >=12 to <18 years) up to 240 weeks. Patients will receive RPV weight-adjusted dose orally once daily in Cohort 2 (children aged >=6 to <12 years) or 25 mg once daily for up to 48 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Cohorts 1 and 2: Pharmacokinetics (PK) of Rilpivirine (TMC278) as Measured by Maximum Observed Plasma Concentration at Steady State (Cmax,ss) | Cmax,ss was the maximum observed plasma concentration of rilpivirine at steady state (steady state starting from Day 14). | Pre-dose, 0, 2, 4, 5, 6, 9, 12 and 24 hours post dose at steady-state (any time during Day 14 to Day 18) |
| Cohort 2: Pharmacokinetics (PK) of Rilpivirine (TMC278) as Measured by Maximum Plasma Concentration at Steady State (Cmax,ss) | Cmax,ss was the maximum plasma concentration of rilpivirine at steady state (steady state starting from Day 14). In the below data table, the measure type "Number" corresponds to Cmax,ss concentration. | Pre-dose, 0, 2, 4, 5, 6, 9, 12 and 24 hours post dose at steady-state (any time during Day 14 to Day 18) |
| Cohorts 1 and 2: Pharmacokinetics of Rilpivirine as Measured by Area Under the Plasma Concentration Curve at Steady State (AUC24, ss) | AUC24,ss was defined as the area under the plasma concentration versus time curve from time 0 to 24 hours post dosing of rilpivirine at steady state (steady state starting from Day 14). | Pre-dose, 0, 2, 4, 5, 6, 9, 12 and 24 hours post dose at steady-state (any time during Day 14 to Day 18) |
| Cohort 2: Pharmacokinetics of Rilpivirine as Measured by Area Under the Plasma Concentration Curve at Steady State (AUC24, ss) | AUC24,ss was defined as the area under the plasma concentration versus time curve from time 0 to 24 hours post dosing of rilpivirine at steady state (steady state starting from Day 14). In the below data table, the measure type "Number" corresponds to AUC24, ss concentration. | Pre-dose, 0, 2, 4, 5, 6, 9, 12 and 24 hours post dose at steady-state (any time during Day 14 to Day 18) |
| Measure | Description | Time Frame |
|---|---|---|
| Cohorts 1 and 2: Number of Participants With Adverse Events (AEs) | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product and did not necessarily have a causal relationship with the treatment. | Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From Baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Sciences Ireland UC Clinical Trial | Janssen Sciences Ireland UC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Syracuse | New York | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34871089 | Derived | Lombaard J, Ssali F, Thanyawee P, Fourie J, Vanveggel S, Linthicum C, Van Eygen V, Van Solingen-Ristea R. Phase 2 Open-Label Study of Long-Term Safety, Tolerability, and Antiviral Activity of Rilpivirine in Antiretroviral-Naive Adolescents Living with HIV-1. Antimicrob Agents Chemother. 2022 Feb 15;66(2):e0091621. doi: 10.1128/AAC.00916-21. Epub 2021 Dec 6. |
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As of Protocol Amendment 10 (PA 10), for Cohort 2 children >=6 to <12 years of age, post Week 48 treatment extension period of 4 years was removed. Hence, the planned efficacy analysis were performed till Week 48 only whereas safety analysis was performed and reported up to Week 240.
A total of 54 antiretroviral-naïve human Immunodeficiency Virus-1 (HIV-1) infected adolescents (aged greater than or equal to [>=] 12 to less than [<] 18 years) and children (aged >=6 to <12 years) were enrolled and treated in Cohort 1 and Cohort 2, respectively.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 Adolescents: Rilpivirine 25 mg | Adolescents (aged >=12 to <18 Years) received rilpivirine (RPV) tablet 25 mg orally QD up to 240 weeks in combination with an investigator-selected background regimen containing 2 nucleos(t)ide reverse transcriptase inhibitors (N[t]RTIs) (zidovudine [AZT], abacavir [ABC] or tenofovir disoproxil fumarate [TDF] in combination with lamivudine [3TC] or emtricitabine [FTC]. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Jun 3, 2020 | Apr 12, 2024 |
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| Zidovudine | Drug | Type=exact, form= appropriate pediatric formulation, unit=mg, route=oral. The patients may receive this selected NRTI together with another NRTI once daily for up to 48 weeks (Cohort 2) and 240 weeks (Cohort 1). |
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| Abacavir | Drug | Type=exact, form=appropriate pediatric formulation, unit=mg, route=oral. The patients may receive this selected NRTI together with another NRTI once daily for up to 48 weeks (Cohort 2) and 240 weeks (Cohort 1). |
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| Tenofovir disoproxil fumarate | Drug | Type=exact, form=appropriate pediatric formulation, unit=mg, route=oral. The patients may receive this selected NRTI together with another NRTI once daily for 240 weeks (Cohort 1). |
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| Lamivudine | Drug | Type=exact, form=appropriate pediatric formulation, unit=mg, route=oral. The patients may receive this selected NRTI together with another NRTI once daily for up to 48 weeks (Cohort 2) and 240 weeks (Cohort 1). |
|
| Emtricitabine | Drug | Type=exact, form=appropriate pediatric formulation, unit=mg, route=oral. The patients may receive this selected NRTI together with another NRTI once daily for up to 48 weeks (Cohort 2) and 240 weeks (Cohort 1). |
|
| Cohorts 1 and 2: Percentage of Participants With Plasma Human Immunodeficiency Virus -1 (HIV-1) Ribonucleic Acid (RNA) Level Less Than (<) 50 Copies/mL by Time to Loss of Virologic Response (TLOVR) Method | Percentage of participants with plasma HIV-1 RNA <50 copies per milliliter (Copies/mL) assessed by TLOVR method was reported. TLOVR requires sustained HIV-1 RNA < 50 copies/mL; confirmed HIV-1 RNA more than or equal to (>=) 50 copies/mL is considered as non-response (rebound); participant was considered non-responder after permanent discontinuation. Responder is defined as the participant with confirmed plasma viral load <50 copies/mL. As planned, combined data for cohort 2 was collected, analyzed and reported for this outcome measure. | At Week 48 (for Cohorts 1 and 2) and at Week 240 (for Cohort 1 only) |
| Cohorts 1 and 2: Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL by Food and Drug Administration (FDA) Snapshot Approach | Percentage of participants with a HIV-1 RNA <50 copies per mL were assessed using FDA snapshot approach which defines a participant's virologic response status using only the viral load at the predefined time point within a window of time, along with study drug discontinuation status. If HIV-1 RNA level is < 50 copies per mL, it is considered as virologic success as per the snapshot approach. As planned, combined data for cohort 2 was collected, analyzed and reported for this outcome measure. | At Week 48 (for Cohorts 1 and 2) and at Week 240 (for Cohort 1 only) |
| Cohorts 1 and 2: Number of Participants With Post Baseline Genotype Data | Number of participants with post baseline genotype (nucleoside analogue reverse transcriptase inhibitors [NRTI] and non-nucleoside reverse transcriptase inhibitors [NNRTI] resistance) data were reported. As planned, combined data for cohort 2 was collected, analyzed and reported for this outcome measure. | Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) |
| Cohorts 1 and 2: Percentage of Participants With Treatment Adherence >95% Based on Drug Accountability | Percentage of participants with treatment adherence >95% based on drug accountability from baseline up to Week 240 for Cohort 1 and from baseline up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) for cohort 2 were reported. Treatment adherence was defined as having a treatment adherence of greater than (>) 95 percent (%) by pill count. Drug accountability included dispensation, receipt, and return, or if applicable, destruction of RPV documented by using the appropriate forms. As planned, combined data for cohort 2 was collected, analyzed and reported for this outcome measure. | Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) |
| Cohorts 1 and 2: Change From Baseline in Cluster of Differentiation (CD4+) Cells | The immunologic change was determined by changes in Cluster of CD4+ cell count using non-completer =failure imputation, that is discontinuation was imputed with baseline value resulting in change=0, other missing data using last observation carried forward (LOCF). Change from baseline in CD4+ cell count at Week 48 for Cohort 1 and 2; and at Week 240 for Cohort 1 only were assessed. As planned, combined data for cohort 2 was collected, analyzed and reported for this outcome measure. | Baseline (Day 1) and Week 48 for Cohorts 1 and 2; Week 240 for Cohort 1 alone |
| Memphis |
| Tennessee |
| United States |
| Chennai | India |
| Mangalore | India |
| Nairobi | Kenya |
| Bucharest | Romania |
| Bloemfontein | South Africa |
| Dundee | South Africa |
| Middelburg | South Africa |
| Pretoria | South Africa |
| Thabazimbi | South Africa |
| Vosloorus | South Africa |
| Bangkok | Thailand |
| Nonthaburi | Thailand |
| Entebbe | Uganda |
| Kampala | Uganda |
| Kiev | Ukraine |
| FG001 | Cohort 2 Children (>=25 kg): Rilpivirine 25 mg | Children (aged >=6 to <12 years) with body weight >=25 kg received rilpivirine 25 mg tablet orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N[t]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC. |
| FG002 | Cohort 2 Children (<25 kg): Rilpivirine 25 mg | Children (aged >=6 to <12 years) with body weight <25 kg received rilpivirine 25 mg tablet orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N[t]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC. |
| FG003 | Cohort 2 Children (>=20 to <25 kg): Rilpivirine 15 mg | Children (aged >=6 to <12 years) with body weight >=20 to <25 kg received rilpivirine 15 mg (6 tablets of 2.5 mg) orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N[t]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC. |
| FG004 | Cohort 2 Children (<20 kg): Rilpivirine 12.5 mg | Children (aged >=6 to <12 years) with body weight <20 kilograms (kg) received rilpivirine 12.5 mg (5 tablets of 2.5 mg) orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N[t]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 Adolescents: Rilpivirine 25 mg | Adolescents (aged >=12 to <18 Years) received rilpivirine (RPV) tablet 25 mg orally QD up to 240 weeks in combination with an investigator-selected background regimen containing 2 nucleos(t)ide reverse transcriptase inhibitors (N[t]RTIs) (zidovudine [AZT], abacavir [ABC] or tenofovir disoproxil fumarate [TDF] in combination with lamivudine [3TC] or emtricitabine [FTC]. |
| BG001 | Cohort 2 Children (>=25 kg): Rilpivirine 25 mg | Children (aged >=6 to <12 years) with body weight >=25 kg received rilpivirine 25 mg tablet orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N[t]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC. |
| BG002 | Cohort 2 Children (<25 kg): Rilpivirine 25 mg | Children (aged >=6 to <12 years) with body weight <25 kg received rilpivirine 25 mg tablet orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N[t]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC. |
| BG003 | Cohort 2 Children (>=20 to <25 kg): Rilpivirine 15 mg | Children (aged >=6 to <12 years) with body weight >=20 to <25 kg received rilpivirine 15 mg (6 tablets of 2.5 mg) orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N[t]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC. |
| BG004 | Cohort 2 Children (<20 kg): Rilpivirine 12.5 mg | Children (aged >=6 to <12 years) with body weight <20 kilograms (kg) received rilpivirine 12.5 mg (5 tablets of 2.5 mg) orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N[t]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | 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 | ||||||||||||||||||||||||||
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| Primary | Cohorts 1 and 2: Pharmacokinetics (PK) of Rilpivirine (TMC278) as Measured by Maximum Observed Plasma Concentration at Steady State (Cmax,ss) | Cmax,ss was the maximum observed plasma concentration of rilpivirine at steady state (steady state starting from Day 14). | Population: participants who took at least 1 dose of RPV, regardless of their compliance with protocol & adherence to dosing regimen. N (Overall number of participants analyzed) =participants evaluable for this outcome measure (OM). In this OM, summarized data for arms "Cohort 2 Children (>=20 to <25 kg): Rilpivirine 15 mg" and "Cohort 2 Children (<20 kg): Rilpivirine 12.5 mg", is not reported as plan was to prepare & report participant wise data when "N" was <3 (which is reported in OM 2). | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | Pre-dose, 0, 2, 4, 5, 6, 9, 12 and 24 hours post dose at steady-state (any time during Day 14 to Day 18) |
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| Primary | Cohort 2: Pharmacokinetics (PK) of Rilpivirine (TMC278) as Measured by Maximum Plasma Concentration at Steady State (Cmax,ss) | Cmax,ss was the maximum plasma concentration of rilpivirine at steady state (steady state starting from Day 14). In the below data table, the measure type "Number" corresponds to Cmax,ss concentration. | Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure. For this OM, participant wise data was only reported because individual data analysis was planned when the 'N' was less than 3. | Posted | Number | nanograms per milliliter (ng/mL) | Pre-dose, 0, 2, 4, 5, 6, 9, 12 and 24 hours post dose at steady-state (any time during Day 14 to Day 18) |
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| Primary | Cohorts 1 and 2: Pharmacokinetics of Rilpivirine as Measured by Area Under the Plasma Concentration Curve at Steady State (AUC24, ss) | AUC24,ss was defined as the area under the plasma concentration versus time curve from time 0 to 24 hours post dosing of rilpivirine at steady state (steady state starting from Day 14). | Population: participants who took at least 1 dose of RPV, regardless of their compliance with protocol & adherence to dosing regimen. N (Overall number of participants analyzed) = participants evaluable for this OM. In this OM, summarized data for arms "Cohort 2 Children (>=20 to <25 kg): Rilpivirine 15 mg" and "Cohort 2 Children (<20 kg): Rilpivirine 12.5 mg", is not reported as plan was to prepare & report participant wise data when "N" was <3 (which is reported in OM 4). | Posted | Mean | Standard Deviation | nanograms*hour per milliliter (ng*hr/mL) | Pre-dose, 0, 2, 4, 5, 6, 9, 12 and 24 hours post dose at steady-state (any time during Day 14 to Day 18) |
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| Primary | Cohort 2: Pharmacokinetics of Rilpivirine as Measured by Area Under the Plasma Concentration Curve at Steady State (AUC24, ss) | AUC24,ss was defined as the area under the plasma concentration versus time curve from time 0 to 24 hours post dosing of rilpivirine at steady state (steady state starting from Day 14). In the below data table, the measure type "Number" corresponds to AUC24, ss concentration. | Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure. For this OM, participant wise data was only reported because individual data analysis was planned when the 'N' was less than 3. | Posted | Number | ng*hr/mL | Pre-dose, 0, 2, 4, 5, 6, 9, 12 and 24 hours post dose at steady-state (any time during Day 14 to Day 18) |
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| Secondary | Cohorts 1 and 2: Number of Participants With Adverse Events (AEs) | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product and did not necessarily have a causal relationship with the treatment. | Analysis population included all participants who had taken at least 1 dose of RPV, regardless of their compliance with the protocol and adherence to the dosing regimen. | Posted | Count of Participants | Participants | Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From Baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) |
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| Secondary | Cohorts 1 and 2: Percentage of Participants With Plasma Human Immunodeficiency Virus -1 (HIV-1) Ribonucleic Acid (RNA) Level Less Than (<) 50 Copies/mL by Time to Loss of Virologic Response (TLOVR) Method | Percentage of participants with plasma HIV-1 RNA <50 copies per milliliter (Copies/mL) assessed by TLOVR method was reported. TLOVR requires sustained HIV-1 RNA < 50 copies/mL; confirmed HIV-1 RNA more than or equal to (>=) 50 copies/mL is considered as non-response (rebound); participant was considered non-responder after permanent discontinuation. Responder is defined as the participant with confirmed plasma viral load <50 copies/mL. As planned, combined data for cohort 2 was collected, analyzed and reported for this outcome measure. | Population: participants who took at least 1 dose of RPV, regardless of compliance with protocol & adherence to dosing regimen. In Cohort 2, "0" in "number analyzed" field of Week 240 = Week 240 was not applicable as it was beyond duration of Cohort 2 (Week 48); 0 in number analyzed field of Week 48 =planned TLOVR method was not used for data analysis per PA 10 and thus no data was reported in this OM. 'n' (number analyzed) =number of participants with available data at specified timepoints. | Posted | Number | Percentage of participants | At Week 48 (for Cohorts 1 and 2) and at Week 240 (for Cohort 1 only) |
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| Secondary | Cohorts 1 and 2: Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL by Food and Drug Administration (FDA) Snapshot Approach | Percentage of participants with a HIV-1 RNA <50 copies per mL were assessed using FDA snapshot approach which defines a participant's virologic response status using only the viral load at the predefined time point within a window of time, along with study drug discontinuation status. If HIV-1 RNA level is < 50 copies per mL, it is considered as virologic success as per the snapshot approach. As planned, combined data for cohort 2 was collected, analyzed and reported for this outcome measure. | Population:participants who took at least 1 dose of RPV, regardless of compliance with protocol & adherence to dosing regimen. "N"(Overall number of participants analyzed)=participants evaluable for this OM. "n"(number analyzed)=number of participants with available data at specified timepoints. In Cohort 2, '0' in 'number analyzed' at Week 240=Week 240 was beyond duration of Cohort 2 (Week 48). '0' in 'number analyzed' of Cohort 1 Week 48=snapshot method was not applicable for Cohort 1 Week 48. | Posted | Number | Percentage of participants | At Week 48 (for Cohorts 1 and 2) and at Week 240 (for Cohort 1 only) |
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| Secondary | Cohorts 1 and 2: Number of Participants With Post Baseline Genotype Data | Number of participants with post baseline genotype (nucleoside analogue reverse transcriptase inhibitors [NRTI] and non-nucleoside reverse transcriptase inhibitors [NNRTI] resistance) data were reported. As planned, combined data for cohort 2 was collected, analyzed and reported for this outcome measure. | Analysis population included all participants who had taken at least 1 dose of RPV, regardless of their compliance with the protocol and adherence to the dosing regimen. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) |
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| Secondary | Cohorts 1 and 2: Percentage of Participants With Treatment Adherence >95% Based on Drug Accountability | Percentage of participants with treatment adherence >95% based on drug accountability from baseline up to Week 240 for Cohort 1 and from baseline up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) for cohort 2 were reported. Treatment adherence was defined as having a treatment adherence of greater than (>) 95 percent (%) by pill count. Drug accountability included dispensation, receipt, and return, or if applicable, destruction of RPV documented by using the appropriate forms. As planned, combined data for cohort 2 was collected, analyzed and reported for this outcome measure. | Analysis population included all participants who had taken at least 1 dose of RPV, regardless of their compliance with the protocol and adherence to the dosing regimen. For Cohort 2, "0" in "number analyzed" field indicated that no participants were available for analysis at Week 240 for Cohort 2 arm because timepoint Week 240 was not applicable to Cohort 2 as it was beyond the duration of Cohort 2 (i.e., Week 48). | Posted | Number | Percentage of participants | Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) |
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| Secondary | Cohorts 1 and 2: Change From Baseline in Cluster of Differentiation (CD4+) Cells | The immunologic change was determined by changes in Cluster of CD4+ cell count using non-completer =failure imputation, that is discontinuation was imputed with baseline value resulting in change=0, other missing data using last observation carried forward (LOCF). Change from baseline in CD4+ cell count at Week 48 for Cohort 1 and 2; and at Week 240 for Cohort 1 only were assessed. As planned, combined data for cohort 2 was collected, analyzed and reported for this outcome measure. | Analysis population included all participants who had taken at least 1 dose of RPV, regardless of their compliance with the protocol and adherence to the dosing regimen. Here, 'n' (number analyzed) signifies the number of participants with available data at each specified timepoint. "0" participants in "number analyzed field" of cohort 2 indicated that Week 240 was not applicable to Cohort 2 as it was beyond the duration of Cohort 2 (i.e., Week 48). | Posted | Mean | Standard Error | Cells per microliter | Baseline (Day 1) and Week 48 for Cohorts 1 and 2; Week 240 for Cohort 1 alone |
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Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10)
Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen.
MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
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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 | Cohort 1 Adolescents: Rilpivirine 25 mg | Adolescents (aged >=12 to <18 Years) received rilpivirine (RPV) tablet 25 mg orally QD up to 240 weeks in combination with an investigator-selected background regimen containing 2 nucleos(t)ide reverse transcriptase inhibitors (N[t]RTIs) (zidovudine [AZT], abacavir [ABC] or tenofovir disoproxil fumarate [TDF] in combination with lamivudine [3TC] or emtricitabine [FTC]. | 0 | 36 | 6 | 36 | 35 | 36 |
| EG001 | Cohort 2 Children (>=25 kg): Rilpivirine 25 mg | Children (aged >=6 to <12 years) with body weight >=25 kg received rilpivirine 25 mg tablet orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N[t]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC. | 0 | 9 | 0 | 9 | 8 | 9 |
| EG002 | Cohort 2 Children (<25 kg): Rilpivirine 25 mg | Children (aged >=6 to <12 years) with body weight <25 kg received rilpivirine 25 mg tablet orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N[t]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC. | 0 | 5 | 0 | 5 | 5 | 5 |
| EG003 | Cohort 2 Children (>=20 to <25 kg): Rilpivirine 15 mg | Children (aged >=6 to <12 years) with body weight >=20 to <25 kg received rilpivirine 15 mg (6 tablets of 2.5 mg) orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N[t]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC. | 0 | 2 | 0 | 2 | 2 | 2 |
| EG004 | Cohort 2 Children (<20 kg): Rilpivirine 12.5 mg | Children (aged >=6 to <12 years) with body weight <20 kilograms (kg) received rilpivirine 12.5 mg (5 tablets of 2.5 mg) orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N[t]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC. | 0 | 2 | 0 | 2 | 2 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drug Hypersensitivity | Immune system disorders | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Abscess Limb | Infections and infestations | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Lobar Pneumonia | Infections and infestations | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Malaria | Infections and infestations | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Suicide Ideation | Psychiatric disorders | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Suicidal Attempt | Psychiatric disorders | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Iron Deficiency Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Rheumatic Heart Disease | Cardiac disorders | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Ventricular Extrasystoles | Cardiac disorders | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Dental Caries | Gastrointestinal disorders | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Fungal Infection | Infections and infestations | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Hepatitis B | Infections and infestations | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Herpes Simplex | Infections and infestations | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Malaria | Infections and infestations | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Oral Herpes | Infections and infestations | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Otitis Media | Infections and infestations | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Acth Stimulation Test Abnormal | Investigations | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Blood Cortisol Decreased | Investigations | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Electrocardiogram QT Prolonged | Investigations | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Protein Total Increased | Investigations | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Vaginal Discharge | Reproductive system and breast disorders | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Dermatitis Atopic | Skin and subcutaneous tissue disorders | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Tooth Extraction | Surgical and medical procedures | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 25.0 and 13.1 | Non-systematic Assessment |
|
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director 1 Clinical Leader | Janssen R&D BE | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 7, 2022 | Apr 12, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| 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 |
| D012897 | Slow Virus Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068696 | Rilpivirine |
| D015215 | Zidovudine |
| C106538 | abacavir |
| D000068698 | Tenofovir |
| D019259 | Lamivudine |
| D000068679 | Emtricitabine |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013936 | Thymidine |
| D011741 | Pyrimidine Nucleosides |
| D015224 | Dideoxynucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
Not provided
Not provided
| Adolescents (12-17 years) |
|
| Adults (18-64 years) |
|
| From 65 to 84 years |
|
| 85 years and over |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Children (aged >=6 to <12 years) with body weight <20 kilograms (kg) received rilpivirine 12.5 mg (5 tablets of 2.5 mg) orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N[t]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.
|
|
Children (aged >=6 to <12 years) with body weight >=25 kg received rilpivirine 25 mg tablet orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N[t]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.
| OG002 | Cohort 2 Children (<25 kg): Rilpivirine 25 mg | Children (aged >=6 to <12 years) with body weight <25 kg received rilpivirine 25 mg tablet orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N[t]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC. |
|
|
Children (aged >=6 to <12 years) with body weight <20 kilograms (kg) received rilpivirine 12.5 mg (5 tablets of 2.5 mg) orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N[t]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC. |
|
|
| OG002 | Cohort 2 Children (<25 kg): Rilpivirine 25 mg | Children (aged >=6 to <12 years) with body weight <25 kg received rilpivirine 25 mg tablet orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N[t]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC. |
| OG003 | Cohort 2 Children (>=20 to <25 kg): Rilpivirine 15 mg | Children (aged >=6 to <12 years) with body weight >=20 to <25 kg received rilpivirine 15 mg (6 tablets of 2.5 mg) orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N[t]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC. |
| OG004 | Cohort 2 Children (<20 kg): Rilpivirine 12.5 mg | Children (aged >=6 to <12 years) with body weight <20 kilograms (kg) received rilpivirine 12.5 mg (5 tablets of 2.5 mg) orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N[t]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC. |
|
|
| OG001 | Cohort 2 (>=6 to <12 Years): Rilpivirine | Participants received rilpivirine tablet 25 mg or adjusted dose orally QD from baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10), in combination with an investigator-selected background regimen containing 2 N[t]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC. |
|
|
| OG001 | Cohort 2 (>=6 to <12 Years): Rilpivirine | Participants received rilpivirine tablet 25 mg or adjusted dose orally QD from baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10), in combination with an investigator-selected background regimen containing 2 N[t]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC. |
|
|
Participants received rilpivirine tablet 25 mg or adjusted dose orally QD from baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10), in combination with an investigator-selected background regimen containing 2 N[t]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.
|
|
| OG001 | Cohort 2 (>=6 to <12 Years): Rilpivirine | Participants received rilpivirine tablet 25 mg or adjusted dose orally QD from baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10), in combination with an investigator-selected background regimen containing 2 N[t]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC. |
|
|
| Cohort 2 (>=6 to <12 Years): Rilpivirine |
Participants received rilpivirine tablet 25 mg or adjusted dose orally QD from baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10), in combination with an investigator-selected background regimen containing 2 N[t]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC. |
|
|