Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
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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