Acquired Immune Deficiency Syndrome (AIDS)Phase 2/3NCT02016924
Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV
A Phase 2/3 study testing ATV, DRV and Cobicistat in people with Acquired Immune Deficiency Syndrome (AIDS) and HIV Infections, run by Gilead Sciences at 23 sites in 7 countries.
Trial summary
The goal of this clinical study is to learn more about the safety and dosing of study drugs, cobicistat-boosted Atazanavir (ATV/co), cobicistat-boosted darunavir (DRV/co) and emtricitabine/tenofovir alafenamide (F/TAF), in children (age ≥ 4 weeks to < 18 years) with HIV. Read more about this study
- Who is it for?
- Ages 4 weeks to 17 years
- Conditions the study is for
- Acquired Immune Deficiency Syndrome (AIDS), HIV Infections
- What is being tested?
- ATV, DRV and Cobicistat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 23 sitesin 7 countries
- Study dates
- 16 Jan 2014to Mar 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 weeks to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- HIV-1 infected, virologically suppressed males and females age ≥ 4 weeks to < 18 years (according to requirements of enrolling Cohort).
- Body weight at screening ≥ 25 to < 40 kg (Cohort 2); ≥ 14 to < 25 kg (Cohort 3); ≥ 3 to < 25 kg (Cohort 4); ≥ 3 to < 14 kg (Cohort 5).
- Stable antiretroviral (ARV) regimen for a minimum of 3 months prior to the screening visit.
- Participants enrolled prior to implementation of Amendment 7: 2 nucleoside reverse transcriptase inhibitors (NRTIs) and ritonavir-boosted atazanavir (ATV/r) once daily or ritonavir-boosted darunavir (DRV/r) once daily or twice daily.
- Participants enrolled after the implementation of Amendment 9:
- Cohorts 2, 3 and 4 (Group 1): 2 NRTIs plus a third agent per local prescribing guidelines. Participants will switch from their current third agent to ATV or darunavir (DRV) at Day 1. Participants taking DRV must be on once-daily dosing or must switch to once daily at or prior to Day 1. Cohort 4 (Group 1), participants may also switch their current third agent to lopinavir boosted with ritonavir (LPV/r) at Day 1. Participants will switch their NRTI backbone to emtricitabine/tenofovir alafenamide (coformulated; Descovy®) (F/TAF).
Show all 19Show fewer
- Cohort 4 (Groups 2 to 4) and Cohort 5 (Groups 1 to 3): 2 NRTIs plus a third agent per local prescribing guidelines or treatment naive. Participants on treatment will switch from their current third agent to ATV or LPV/r (Cohort 4 (Groups 2 to 4)), or to a third unboosted agent (Cohort 5 (Groups 1 to 3)). Participants will switch their NRTI backbone to F/TAF.
- Participants undergoing dose modifications to their ARV regimen for growth or switching medication formulations are considered to be on a stable ARV regimen.
- Documented plasma human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) for ≥ 3 months preceding the screening visit:
- Participants enrolled after the implementation of Amendment 9:
- For Cohorts 2, 3, and 4 (Group 1), virologically suppressed ≥ 3 months preceding the screening visit: HIV-1 RNA < 50 copies/mL on a stable regimen (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL).
- For Cohorts 4 (Groups 2 to 4) and Cohort 5 (Groups 1 to 3), on an ARV regimen irrespective of plasma HIV-1 RNA copies or treatment naive; a participant is considered treatment naive, if ARVs were given for prevention of mother-to-child transmission but not for HIV treatment.
- For virologically suppressed participants, unconfirmed virologic elevations of HIV-1 RNA ≥ 50 copies/mL (transient detectable viremia, or "blip") prior to screening are acceptable. If the lower limit of detection of the local HIV-1 RNA assay is < 50 copies/mL (eg, < 20 copies/mL), the plasma HIV-1 RNA level cannot exceed 50 copies/mL on 2 consecutive HIV-1 RNA tests.
- Adequate renal function: Estimated glomerular filtration rate (eGFR) ≥ 90 mL/min/1.73m2 using the Schwartz formula. If ≥ 1 year old, eGFR greater than or equal to the minimum normal value for age using the Schwartz formula. If < 1 year old as follows:
- Age minimum value for eGFR (mL/min/1.73 m2) > 28 days to ≤ 95 days is 30, ≥ 96 days to ≤ 6 months is 39, > 6 to < 12 months is 49.
- Participants must not have documented or suspected resistance to applicable study drugs including emtricitabine (Emtriva®) (FTC), TFV, ATV, DRV, or LPV. Participants < 14 kg (Cohorts 4 (Groups 2 to 4) and 5 (Groups 1 to 3)) with M184V/I AND HIV-1 RNA < 50 copies/mL will be allowed.
- Positive confirmatory HIV test (confirmatory nucleic acid-based testing if < 18 months of age).
- Cohort 4 (Groups 2 to 4) and Cohort 5 (Groups 1 to 3): Last dose of nevirapine or efavirenz, if applicable, ≥ 14 days prior to enrollment.
- Note: Other protocol defined Inclusion/Exclusion criteria do apply.
Who cannot join
None listed.
Trial locations and contacts
23 sites in 7 countries.
23 sites in 7 countries
United States7 sites
University of Colorado Denver
Aurora, Colorado, 80045
University of Texas Health Science Center of Houston
Houston, Texas, 77030
Pediatric Infectious Disease Associates
Long Beach, California, 90806
Peter Morton Medical Building
Los Angeles, California, 90095
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
University of South Florida
Tampa, Florida, 33606
The George Washington University
Washington D.C., District of Columbia, 20010
South Africa6 sites
University of the Free State
Bloemfontein, 9300
University of Stellenbosch
Cape Town, 7505
King Edward VIII Hospital
Durban, 3629
Rahima Clinical Trials, a Division of Wits Health Consortium (Pty) Ltd
Johannesburg, 2093
The Aurum Institute: Pretoria Clinical Research Centre
Pretoria, 87
Perinatal HIV Research Unit
Soweto, 2013
Thailand3 sites
HIV-NAT
Bangkok, 10330
Siriraj Hospital
Bangkok, 10700
Srinagarind Hospital
Khon Kaen, 40002
Uganda3 sites
MU-JHU Research Collaboration/MU-JHU Care Ltd
Kampala, 256
SICRA-TASO Mulago National Referral Hospital
Kampala
AMBSO Masaka Clinical Research Site
Masaka
Argentina2 sites
Hospital General de Agudos Cosme Argerich
Buenos Aires, 1151
Helios Salud
Buenos Aires, C1141 ACG
United Kingdom1 site
Imperial College Healthcare NHS Trust
London, W2 1NY
About this study
Official title: A Phase 2/3, Multicenter, Open-label, Multicohort Study Evaluating Pharmacokinetics (PK), Safety, and Efficacy of Cobicistat-boosted Atazanavir (ATV/co) or Cobicistat-boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in HIV-1 Infected, Virologically Suppressed Pediatric Participants
The goal of this clinical study is to learn more about the safety and dosing of study drugs, cobicistat-boosted Atazanavir (ATV/co), cobicistat-boosted darunavir (DRV/co) and emtricitabine/tenofovir alafenamide (F/TAF), in children (age ≥ 4 weeks to < 18 years) with HIV.
- Being tested
- ATV, DRV, Cobicistat, BR, F/TAF
- Keywords
- Pediatrics, Adolescents, HIV, HIV-1, Treatment experienced
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATVDrug
Also called Reyataz®
Capsules administered once daily according to dosing recommendations per product monograph
DRVDrug
Also called Prezista®
Tablets administered once daily according to dosing recommendations per product monograph
CobicistatDrug
Also called GS-9350, Tybost®
Tablets administered orally once daily with food
BRDrug
Background Regimen (BR) include Food and Drug Administration (FDA)-approved nucleos(t)ide reverse transcriptase inhibitors (NRTIs) including zidovudine (ZDV), stavudine (d4T), didanosine (ddI), abacavir (ABC), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), lamivudine (3TC), and emtricitabine (FTC).
F/TAFDrug
Also called Descovy®
Tablets administered orally once daily
LPV/rDrug
Solution administered orally
Third Unboosted DrugDrug
ATV (administered orally), DRV (administered orally), and LPV/r (administered orally) would be general list but unspecified for sites.
Cobicistat TOSDrug
Also called GS-9350, Tybost®
Tablets for oral suspension
F/TAF TOSDrug
Also called Descovy®
Tablets for oral suspension
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Part A and Part B | Experimental | Participants ages 12 to <18 years old will receive cobicistat 150 mg with either ATV or DRV plus background regimen (BR). The BR may contain additional antiretroviral agents except for the following disallowed agents: saquinavir, indinavir, nelfinavir, double protease inhibitor (PI) regimens, raltegravir, elvitegravir, efavirenz, nevirapine, delavirdine, maraviroc, etravirine, rilpivirine, dolutegravir, and investigational antiretroviral agents. Receives: Drug: ATV; Drug: DRV; Drug: Cobicistat; Drug: BR |
| Cohort 2 | Experimental | Participants aged 6 to <12 years old and ≥25 to <40kg will receive cobicistat 150 mg and F/TAF 200/25 mg with either ATV or DRV. Receives: Drug: ATV; Drug: DRV; Drug: Cobicistat; Drug: F/TAF |
| Cohort 3 | Experimental | Participants age ≥ 2 years old will receive cobicistat 90 mg and F/TAF 120/15 mg with either ATV or DRV. Receives: Drug: ATV; Drug: DRV; Drug: Cobicistat; Drug: F/TAF |
| Cohort 4 (Group 1) | Experimental | Participants age ≥ 4 weeks old weighing 14 to < 25 kg will receive cobicistat tablet for oral suspension (TOS) 90 mg, once daily and F/TAF TOS 120/15 mg, once daily with either ATV or DRV or lopinavir boosted by ritonavir (LPV/r). Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, minimum age and weight for DRV is ≥ 3 years and ≥ 15 kg; participants receiving LPV/r will not receive cobicistat TOS. Receives: Drug: ATV; Drug: DRV; Drug: LPV/r; Drug: Cobicistat TOS; Drug: F/TAF TOS |
| Cohort 4 (Group 2) | Experimental | Participants age ≥ 4 weeks old weighing 10 to < 14 kg will receive cobicistat TOS 30 mg (twice daily) and F/TAF TOS 60/7.5 mg, once daily with either ATV or LPV/r. Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, respectively; participants receiving LPV/r will not receive cobicistat TOS. Receives: Drug: ATV; Drug: LPV/r; Drug: Cobicistat TOS; Drug: F/TAF TOS |
| Cohort 4 (Group 3) | Experimental | Participants age ≥ 4 weeks old weighing 6 to < 10 kg will receive cobicistat TOS 30 mg (twice daily) and F/TAF TOS 30/3.75 mg, once daily with either ATV or LPV/r. Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, respectively; participants receiving LPV/r will not receive cobicistat TOS. Receives: Drug: ATV; Drug: LPV/r; Drug: Cobicistat TOS; Drug: F/TAF TOS |
| Cohort 4 (Group 4) | Experimental | Participants age ≥ 4 weeks old weighing 3 to < 6 kg will receive cobicistat TOS 30 mg (twice daily) and F/TAF TOS 15/1.88 mg, once daily with either ATV or LPV/r. Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, respectively; participants receiving LPV/r will not receive cobicistat TOS. Receives: Drug: ATV; Drug: LPV/r; Drug: Cobicistat TOS; Drug: F/TAF TOS |
| Cohort 5 (Group 1) | Experimental | Participants ages ≥ 4 weeks old weighing ≥ 10 to < 14 kg will receive F/TAF TOS 60/7.5 mg, once daily with the third unboosted drug. Receives: Drug: Third Unboosted Drug; Drug: F/TAF TOS |
| Cohort 5 (Group 2) | Experimental | Participants ages ≥ 4 weeks old weighing ≥ 6 to < 10 kg will receive F/TAF TOS 30/3.75 mg, once daily with the third unboosted drug. Receives: Drug: Third Unboosted Drug; Drug: F/TAF TOS |
| Cohort 5 (Group 3) | Experimental | Participants ages ≥ 4 weeks old weighing ≥ 3 to < 6 kg will receive F/TAF TOS 15/1.88 mg, once daily with the third unboosted drug. Receives: Drug: Third Unboosted Drug; Drug: F/TAF TOS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic (PK) Parameter: AUCtau of ATV, DRV, TAF, and TFV
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
AUCtau for ATV (Cohorts 1 Part A, 2, 3, and 4 [Groups 2 to 4]); DRV (Cohorts 1 Part A, 2, and 3); TAF (Cohorts 2, 3, 4 [Groups 1 to 4] and 5 [Groups 1 to 3] taking F/TAF); and TFV (Cohorts 2, 3, 4 [Groups 1 to 4] and 5 [Groups 1 to 3] taking F/TAF) will be reported.
Measured: Predose on Day 1, and postdose up to Week 48
Percentage of Participants Experiencing Treatment Emergent Adverse Events (AEs) Through Week 24
Measured: First dose date up to Week 24 plus 30 days (Cumulative data through Week 24)
Percentage of Participants Experiencing Treatment Emergent Laboratory Abnormalities Through Week 24
Measured: First dose date up to Week 24 plus 30 days (Cumulative data through Week 24)
Secondary outcomes (16)
PK Parameter: Ctau of ATV, DRV, COBI, FTC and TFV
Ctau is defined as the observed drug concentration at the end of the dosing interval.
Ctau for ATV (cohorts 1, 2, 3, and 4 (Groups 2 to 4)), DRV (cohorts 1, 2, and 3), COBI (except Cohort 5), FTC and TFV (cohorts 2, 3, 4 [Groups 1 to 4] and 5 taking F/TAF) will be reported.
Measured: Predose on Day 1, and postdose up to Week 48
PK Parameter: Cmax of ATV, DRV, COBI, TAF, FTC and TFV
Cmax is defined as the maximum observed concentration of drug.
Cmax for ATV (Cohorts 1, 2, 3, and 4 [Groups 2 to 4]) and DRV (Cohorts 1, 2, and 3); for COBI (except Cohort 5); for TAF, FTC and TFV (Cohorts 2, 3, 4 [Groups 1 to 4] and 5 taking F/TAF) will be reported.
Measured: Predose on Day 1, and postdose up to Week 48
PK Parameter: CL/F of ATV, DRV, COBI, TAF, FTC and TFV
CL/F is defined as the apparent oral clearance following administration of the drug.
CL/F for ATV (Cohorts 1, 2, 3, and 4 [Groups 2 to 4]) and DRV (Cohorts 1, 2, and 3); for COBI (except Cohort 5); for TAF, FTC and TFV (Cohorts 2, 3, 4 [Groups 1 to 4] and 5 taking F/TAF) will be reported.
Measured: Predose on Day 1, and postdose up to Week 48
PK Parameter: Vz/F of COBI, TAF, FTC and TFV
Vz/F is defined as the apparent volume of distribution of the drug.
Vz/F for COBI (Except Cohort 5); for TAF (Cohorts 2, 3, 4 [Groups 1 to 4] and 5 taking F/TAF); for FTC and TFV (Cohorts 2, 3, 4 [Groups 1 to 4] and 5 taking F/TAF) will be reported.
Measured: Predose on Day 1, and postdose up to Week 48
PK Parameter: AUCtau of COBI and FTC
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
AUCtau for COBI (Except Cohort 5) and FTC will be reported.
Measured: Predose on Day 1, and postdose up to Week 48
PK Parameter: AUClast of TAF, FTC and TFV
AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration.
AUClast for TAF (Cohorts 2, 3, 4 [Groups 1 to 4] and 5 taking F/TAF); for FTC and TFV (Cohorts 2, 3, 4 [Groups 1 to 4] and 5 taking F/TAF) will be reported.
Measured: Predose on Day 1, and postdose up to Week 48
PK Parameter: Clast of TAF
Clast is defined as the the last observed quantifiable concentration of the drug in plasma.
Clast for TAF (Cohorts 2, 3, 4 [Groups 1 to 4] and 5 taking F/TAF) will be reported.
Measured: Predose on Day 1, and postdose up to Week 48
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Measured: First dose date up to Week 48 plus 30 days (Cumulative data through Week 48)
Percentage of Participants Experiencing Clinically Significant Changes in Safety Laboratory Values
Measured: First dose date up to Week 48 plus 30 days (Cumulative data through Week 48)
Percentage of Participants with HIV-1 RNA < 50 Copies/mL at Week 24 and as Defined by the US FDA-defined Snapshot Algorithm
Measured: Week 24
Percentage of Participants with HIV-1 RNA < 50 Copies/mL at Week 48 and as Defined by the US FDA-defined Snapshot Algorithm
Measured: Week 48
Change from Baseline in CD4+ Cell Counts (cells/μL) at Week 24
Measured: Baseline, Week 24
Change from Baseline in CD4+ Cell Counts (cells/μL) at Week 48
Measured: Baseline, Week 48
Change from Baseline in Percentage of CD4+ Cells at Week 24
Measured: Baseline, Week 24
Change from Baseline in Percentage of CD4+ Cells at Week 48
Measured: Baseline, Week 48
Acceptability of COBI and F/TAF as Measured by Palatability Score
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study start16 Jan 2014
- Primary completion13 Jun 2025
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Immune Deficiency Syndrome (AIDS)Studies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016924
- Sponsor's protocol ID
- GS-US-216-0128
- Other IDs
- 2013-001402-28, IS000883
- Status last verified
- Apr 2026
- First submitted
- 16 Dec 2013
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2/3, Multicenter, Open-label, Multicohort Study Evaluating Pharmacokinetics (PK), Safety, and Efficacy of Cobicistat-boosted Atazanavir (ATV/co) or Cobicistat-boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in HIV-1 Infected, Virologically Suppressed Pediatric Participants
- ClinicalTrials.gov ID
- NCT02016924
- Acronym / sponsor ID
- GS-US-216-0128
- Keywords
- Pediatrics, Adolescents, HIV, HIV-1, Treatment experienced
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2014 (actual)
- Primary completion
- 13 Jun 2025 (actual)
- Study completion
- Mar 2027 (estimated)
- First posted
- 20 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical study is to learn more about the safety and dosing of study drugs, cobicistat-boosted Atazanavir (ATV/co), cobicistat-boosted darunavir (DRV/co) and emtricitabine/tenofovir alafenamide (F/TAF), in children (age ≥ 4 weeks to < 18 years) with HIV.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Part A and Part B | Experimental | Drug: ATV, Drug: DRV, Drug: Cobicistat, Drug: BRParticipants ages 12 to <18 years old will receive cobicistat 150 mg with either ATV or DRV plus background regimen (BR). The BR may contain additional antiretroviral agents except for the following disallowed agents: saquinavir, indinavir, nelfinavir, double protease inhibitor (PI) regimens, raltegravir, elvitegravir, efavirenz, nevirapine, delavirdine, maraviroc, etravirine, rilpivirine, dolutegravir, and investigational antiretroviral agents. |
| Cohort 2 | Experimental | Drug: ATV, Drug: DRV, Drug: Cobicistat, Drug: F/TAFParticipants aged 6 to <12 years old and ≥25 to <40kg will receive cobicistat 150 mg and F/TAF 200/25 mg with either ATV or DRV. |
| Cohort 3 | Experimental | Drug: ATV, Drug: DRV, Drug: Cobicistat, Drug: F/TAFParticipants age ≥ 2 years old will receive cobicistat 90 mg and F/TAF 120/15 mg with either ATV or DRV. |
| Cohort 4 (Group 1) | Experimental | Drug: ATV, Drug: DRV, Drug: LPV/r, Drug: Cobicistat TOS, Drug: F/TAF TOSParticipants age ≥ 4 weeks old weighing 14 to < 25 kg will receive cobicistat tablet for oral suspension (TOS) 90 mg, once daily and F/TAF TOS 120/15 mg, once daily with either ATV or DRV or lopinavir boosted by ritonavir (LPV/r). Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, minimum age and weight for DRV is ≥ 3 years and ≥ 15 kg; participants receiving LPV/r will not receive cobicistat TOS. |
| Cohort 4 (Group 2) | Experimental | Drug: ATV, Drug: LPV/r, Drug: Cobicistat TOS, Drug: F/TAF TOSParticipants age ≥ 4 weeks old weighing 10 to < 14 kg will receive cobicistat TOS 30 mg (twice daily) and F/TAF TOS 60/7.5 mg, once daily with either ATV or LPV/r. Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, respectively; participants receiving LPV/r will not receive cobicistat TOS. |
| Cohort 4 (Group 3) | Experimental | Drug: ATV, Drug: LPV/r, Drug: Cobicistat TOS, Drug: F/TAF TOSParticipants age ≥ 4 weeks old weighing 6 to < 10 kg will receive cobicistat TOS 30 mg (twice daily) and F/TAF TOS 30/3.75 mg, once daily with either ATV or LPV/r. Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, respectively; participants receiving LPV/r will not receive cobicistat TOS. |
| Cohort 4 (Group 4) | Experimental | Drug: ATV, Drug: LPV/r, Drug: Cobicistat TOS, Drug: F/TAF TOSParticipants age ≥ 4 weeks old weighing 3 to < 6 kg will receive cobicistat TOS 30 mg (twice daily) and F/TAF TOS 15/1.88 mg, once daily with either ATV or LPV/r. Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, respectively; participants receiving LPV/r will not receive cobicistat TOS. |
| Cohort 5 (Group 1) | Experimental | Drug: Third Unboosted Drug, Drug: F/TAF TOSParticipants ages ≥ 4 weeks old weighing ≥ 10 to < 14 kg will receive F/TAF TOS 60/7.5 mg, once daily with the third unboosted drug. |
| Cohort 5 (Group 2) | Experimental | Drug: Third Unboosted Drug, Drug: F/TAF TOSParticipants ages ≥ 4 weeks old weighing ≥ 6 to < 10 kg will receive F/TAF TOS 30/3.75 mg, once daily with the third unboosted drug. |
| Cohort 5 (Group 3) | Experimental | Drug: Third Unboosted Drug, Drug: F/TAF TOSParticipants ages ≥ 4 weeks old weighing ≥ 3 to < 6 kg will receive F/TAF TOS 15/1.88 mg, once daily with the third unboosted drug. |
Who may qualify
- Ages
- 4 weeks to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (19 listed)
- HIV-1 infected, virologically suppressed males and females age ≥ 4 weeks to < 18 years (according to requirements of enrolling Cohort).
- Body weight at screening ≥ 25 to < 40 kg (Cohort 2); ≥ 14 to < 25 kg (Cohort 3); ≥ 3 to < 25 kg (Cohort 4); ≥ 3 to < 14 kg (Cohort 5).
- Stable antiretroviral (ARV) regimen for a minimum of 3 months prior to the screening visit.
- Participants undergoing dose modifications to their ARV regimen for growth or switching medication formulations are considered to be on a stable ARV regimen.
- Documented plasma human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) for ≥ 3 months preceding the screening visit:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATVAlso: Reyataz®Capsules administered once daily according to dosing recommendations per product monograph | Drug | Cohort 1: Part A and Part B, Cohort 2, Cohort 3, Cohort 4 (Group 1), Cohort 4 (Group 2), Cohort 4 (Group 3), Cohort 4 (Group 4) |
| DRVAlso: Prezista®Tablets administered once daily according to dosing recommendations per product monograph | Drug | Cohort 1: Part A and Part B, Cohort 2, Cohort 3, Cohort 4 (Group 1) |
| CobicistatAlso: GS-9350, Tybost®Tablets administered orally once daily with food | Drug | Cohort 1: Part A and Part B, Cohort 2, Cohort 3 |
| BRBackground Regimen (BR) include Food and Drug Administration (FDA)-approved nucleos(t)ide reverse transcriptase inhibitors (NRTIs) including zidovudine (ZDV), stavudine (d4T), didanosine (ddI), abacavir (ABC), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), lamivudine (3TC), and emtricitabine (FTC). | Drug | Cohort 1: Part A and Part B |
| F/TAFAlso: Descovy®Tablets administered orally once daily | Drug | Cohort 2, Cohort 3 |
| LPV/rSolution administered orally | Drug | Cohort 4 (Group 1), Cohort 4 (Group 2), Cohort 4 (Group 3), Cohort 4 (Group 4) |
| Third Unboosted DrugATV (administered orally), DRV (administered orally), and LPV/r (administered orally) would be general list but unspecified for sites. | Drug | Cohort 5 (Group 1), Cohort 5 (Group 2), Cohort 5 (Group 3) |
| Cobicistat TOSAlso: GS-9350, Tybost®Tablets for oral suspension | Drug | Cohort 4 (Group 1), Cohort 4 (Group 2), Cohort 4 (Group 3), Cohort 4 (Group 4) |
| F/TAF TOSAlso: Descovy®Tablets for oral suspension | Drug | Cohort 4 (Group 1), Cohort 4 (Group 2), Cohort 4 (Group 3), Cohort 4 (Group 4), Cohort 5 (Group 1), Cohort 5 (Group 2), Cohort 5 (Group 3) |
Primary outcome
Pharmacokinetic (PK) Parameter: AUCtau of ATV, DRV, TAF, and TFV
Time frame: Predose on Day 1, and postdose up to Week 48
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). AUCtau for ATV (Cohorts 1 Part A, 2, 3, and 4 [Groups 2 to 4]); DRV (Cohorts 1 Part A, 2, and 3); TAF (Cohorts 2, 3, 4 [Groups 1 to 4] and 5 [Groups 1 to 3] taking F/TAF); and TFV (Cohorts 2, 3, 4 [Groups 1 to 4] and 5 [Groups 1 to 3] taking F/TAF) will be reported.
Percentage of Participants Experiencing Treatment Emergent Adverse Events (AEs) Through Week 24
Time frame: First dose date up to Week 24 plus 30 days (Cumulative data through Week 24)
Percentage of Participants Experiencing Treatment Emergent Laboratory Abnormalities Through Week 24
Time frame: First dose date up to Week 24 plus 30 days (Cumulative data through Week 24)
16 secondary outcomes
PK Parameter: Ctau of ATV, DRV, COBI, FTC and TFV
Time frame: Predose on Day 1, and postdose up to Week 48
PK Parameter: Cmax of ATV, DRV, COBI, TAF, FTC and TFV
Time frame: Predose on Day 1, and postdose up to Week 48
PK Parameter: CL/F of ATV, DRV, COBI, TAF, FTC and TFV
Time frame: Predose on Day 1, and postdose up to Week 48
PK Parameter: Vz/F of COBI, TAF, FTC and TFV
Time frame: Predose on Day 1, and postdose up to Week 48
PK Parameter: AUCtau of COBI and FTC
Time frame: Predose on Day 1, and postdose up to Week 48
PK Parameter: AUClast of TAF, FTC and TFV
Time frame: Predose on Day 1, and postdose up to Week 48
PK Parameter: Clast of TAF
Time frame: Predose on Day 1, and postdose up to Week 48
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame: First dose date up to Week 48 plus 30 days (Cumulative data through Week 48)
Percentage of Participants Experiencing Clinically Significant Changes in Safety Laboratory Values
Time frame: First dose date up to Week 48 plus 30 days (Cumulative data through Week 48)
Percentage of Participants with HIV-1 RNA < 50 Copies/mL at Week 24 and as Defined by the US FDA-defined Snapshot Algorithm
Time frame: Week 24
Percentage of Participants with HIV-1 RNA < 50 Copies/mL at Week 48 and as Defined by the US FDA-defined Snapshot Algorithm
Time frame: Week 48
Change from Baseline in CD4+ Cell Counts (cells/μL) at Week 24
Time frame: Baseline, Week 24
Change from Baseline in CD4+ Cell Counts (cells/μL) at Week 48
Time frame: Baseline, Week 48
Change from Baseline in Percentage of CD4+ Cells at Week 24
Time frame: Baseline, Week 24
Change from Baseline in Percentage of CD4+ Cells at Week 48
Time frame: Baseline, Week 48
Acceptability of COBI and F/TAF as Measured by Palatability Score
Time frame: Week 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
23 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ATV, DRV and Cobicistat in people with Acquired Immune Deficiency Syndrome (AIDS) and HIV Infections, run by Gilead Sciences at 23 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, South Africa, Thailand, Uganda, Argentina and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic (PK) Parameter: AUCtau of ATV, DRV, TAF, and TFV (time frame: Predose on Day 1, and postdose up to Week 48). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.