Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV
NCT ID: NCT02016924
Last Updated: 2025-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
133 participants
INTERVENTIONAL
2014-01-16
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1: Part A and Part B
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.
ATV
Capsules administered once daily according to dosing recommendations per product monograph
DRV
Tablets administered once daily according to dosing recommendations per product monograph
Cobicistat
Tablets administered orally once daily with food
BR
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).
Cohort 2
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.
ATV
Capsules administered once daily according to dosing recommendations per product monograph
DRV
Tablets administered once daily according to dosing recommendations per product monograph
Cobicistat
Tablets administered orally once daily with food
F/TAF
Tablets administered orally once daily
Cohort 3
Participants age ≥ 2 years old will receive cobicistat 90 mg and F/TAF 120/15 mg with either ATV or DRV.
ATV
Capsules administered once daily according to dosing recommendations per product monograph
DRV
Tablets administered once daily according to dosing recommendations per product monograph
Cobicistat
Tablets administered orally once daily with food
F/TAF
Tablets administered orally once daily
Cohort 4 (Group 1)
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.
ATV
Capsules administered once daily according to dosing recommendations per product monograph
DRV
Tablets administered once daily according to dosing recommendations per product monograph
LPV/r
Solution administered orally
Cobicistat TOS
Tablets for oral suspension
F/TAF TOS
Tablets for oral suspension
Cohort 4 (Group 2)
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.
ATV
Capsules administered once daily according to dosing recommendations per product monograph
LPV/r
Solution administered orally
Cobicistat TOS
Tablets for oral suspension
F/TAF TOS
Tablets for oral suspension
Cohort 4 (Group 3)
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.
ATV
Capsules administered once daily according to dosing recommendations per product monograph
LPV/r
Solution administered orally
Cobicistat TOS
Tablets for oral suspension
F/TAF TOS
Tablets for oral suspension
Cohort 4 (Group 4)
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.
ATV
Capsules administered once daily according to dosing recommendations per product monograph
LPV/r
Solution administered orally
Cobicistat TOS
Tablets for oral suspension
F/TAF TOS
Tablets for oral suspension
Cohort 5 (Group 1)
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.
Third Unboosted Drug
ATV (administered orally), DRV (administered orally), and LPV/r (administered orally) would be general list but unspecified for sites.
F/TAF TOS
Tablets for oral suspension
Cohort 5 (Group 2)
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.
Third Unboosted Drug
ATV (administered orally), DRV (administered orally), and LPV/r (administered orally) would be general list but unspecified for sites.
F/TAF TOS
Tablets for oral suspension
Cohort 5 (Group 3)
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.
Third Unboosted Drug
ATV (administered orally), DRV (administered orally), and LPV/r (administered orally) would be general list but unspecified for sites.
F/TAF TOS
Tablets for oral suspension
Interventions
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ATV
Capsules administered once daily according to dosing recommendations per product monograph
DRV
Tablets administered once daily according to dosing recommendations per product monograph
Cobicistat
Tablets administered orally once daily with food
BR
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/TAF
Tablets administered orally once daily
LPV/r
Solution administered orally
Third Unboosted Drug
ATV (administered orally), DRV (administered orally), and LPV/r (administered orally) would be general list but unspecified for sites.
Cobicistat TOS
Tablets for oral suspension
F/TAF TOS
Tablets for oral suspension
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
* 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.
4 Weeks
17 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Pediatric Infectious Disease Associates
Long Beach, California, United States
Peter Morton Medical Building
Los Angeles, California, United States
University of Colorado Denver
Aurora, Colorado, United States
The George Washington University
Washington D.C., District of Columbia, United States
University of South Florida
Tampa, Florida, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
University of Texas Health Science Center of Houston
Houston, Texas, United States
Hospital General de Agudos Cosme Argerich
Buenos Aires, , Argentina
Helios Salud
Buenos Aires, , Argentina
University of the Free State
Bloemfontein, , South Africa
University of Stellenbosch
Cape Town, , South Africa
King Edward VIII Hospital
Durban, , South Africa
Rahima Clinical Trials, a Division of Wits Health Consortium (Pty) Ltd
Johannesburg, , South Africa
The Aurum Institute: Pretoria Clinical Research Centre
Pretoria, , South Africa
Perinatal HIV Research Unit
Soweto, , South Africa
HIV-NAT
Bangkok, , Thailand
Siriraj Hospital
Bangkok, , Thailand
Srinagarind Hospital
Khon Kaen, , Thailand
MU-JHU Research Collaboration/MU-JHU Care Ltd
Kampala, , Uganda
SICRA-TASO Mulago National Referral Hospital
Kampala, , Uganda
AMBSO Masaka Clinical Research Site
Masaka, , Uganda
Imperial College Healthcare NHS Trust
London, , United Kingdom
University of Zimbabwe Clinical Research Centre
Harare, , Zimbabwe
Countries
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Related Links
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Gilead Clinical Trials Website
Other Identifiers
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2013-001402-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IS000883
Identifier Type: OTHER
Identifier Source: secondary_id
GS-US-216-0128
Identifier Type: -
Identifier Source: org_study_id
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