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Active, not recruiting Phase 2/3

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

NCT02016924 · tracked via the Priya Life Science UK tracker
Phase
Phase 2/3
Started
2014-01-16
Last updated
2026-04-21

Condition(s) studied

Acquired Immune Deficiency Syndrome (AIDS)HIV Infections

Investigational drug(s) / intervention(s)

ATVDRVCobicistat →BRF/TAF →LPV/r →Third Unboosted DrugCobicistat TOS →F/TAF 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

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

Study 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.

Eligibility

Sex
ALL
Min age
4 Weeks
Max age
17 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Pharmacokinetic (PK) Parameter: AUCtau of ATV, DRV, TAF, and TFV — 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 — 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 — First dose date up to Week 24 plus 30 days (Cumulative data through Week 24)

Trial sites (23)

FacilityCityRegionStatus
Pediatric Infectious Disease Associates Long Beach California
Peter Morton Medical Building Los Angeles California
University of Colorado Denver Aurora Colorado
The George Washington University Washington D.C. District of Columbia
University of South Florida Tampa Florida
St. Jude Children's Research Hospital Memphis Tennessee
University of Texas Health Science Center of Houston Houston Texas
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02016924 on ClinicalTrials.gov ↗ ← All trials in the UK