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Active (not recruiting) Phase 2/3 NCT02016924

Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV

Phase 2/3 – combined trial
Conditions: Acquired Immune Deficiency Syndrome (AIDS) HIV Infections

Sponsor: Gilead Sciences

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Overview
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.
Who can participate
Key Inclusion Criteria: * 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). * 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.
Interventions
ATV
DRUG
DRV
DRUG
Cobicistat
DRUG
BR
DRUG
F/TAF
DRUG
LPV/r
DRUG
Third Unboosted Drug
DRUG
Cobicistat TOS
DRUG
F/TAF TOS
DRUG
Locations 23
Argentina (2)
Hospital General de Agudos Cosme Argerich
Buenos Aires
Helios Salud
Buenos Aires
South Africa (6)
University of the Free State
Bloemfontein
University of Stellenbosch
Cape Town
King Edward VIII Hospital
Durban
Rahima Clinical Trials, a Division of Wits Health Consortium (Pty) Ltd
Johannesburg
The Aurum Institute: Pretoria Clinical Research Centre
Pretoria
Perinatal HIV Research Unit
Soweto
Thailand (3)
HIV-NAT
Bangkok
Siriraj Hospital
Bangkok
Srinagarind Hospital
Khon Kaen
Uganda (3)
MU-JHU Research Collaboration/MU-JHU Care Ltd
Kampala
SICRA-TASO Mulago National Referral Hospital
Kampala
AMBSO Masaka Clinical Research Site
Masaka
United Kingdom (1)
Imperial College Healthcare NHS Trust
London
United States (7)
University of Colorado Denver
Aurora , Colorado
University of Texas Health Science Center of Houston
Houston , Texas
Pediatric Infectious Disease Associates
Long Beach , California
Peter Morton Medical Building
Los Angeles , California
St. Jude Children's Research Hospital
Memphis , Tennessee
University of South Florida
Tampa , Florida
The George Washington University
Washington D.C. , District of Columbia
Zimbabwe (1)
University of Zimbabwe Clinical Research Centre
Harare
Technical details
Status
Active (not recruiting)
Phase
Phase 2/3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
4 Weeks
Maximum age
17 Years
Healthy volunteers
No
Start date
16.01.2014
Completion date
01.03.2027
Registry ID
NCT02016924
Source
clinicaltrials.gov
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