Study Details

OVERVIEW

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

PROTOCOL 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.

Participation Requirements

Age

4 Weeks - 17 Years

Sex

ALL

Healthy Volunteers

Medical Condition

Acquired Immune Deficiency Syndrome (AIDS), HIV Infections

Gender

N/A

Date

January 2014 - June 2025

Study Type

INTERVENTIONAL

Study Phase

PHASE2, PHASE3

Product

ATV, DRV, Cobicistat, BR, F/TAF, LPV/r, Third Unboosted Drug, Cobicistat TOS, F/TAF TOS

Eligibility Information

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.

Exclusion Criteria

No Exclusion Criteria present

Locations

Locations (23)

Pediatric Infectious Disease Associates

Long Beach, California, United States, 90806

Peter Morton Medical Building

Los Angeles, California, United States, 90095

University of Colorado Denver

Aurora, Colorado, United States, 80045

The George Washington University

Washington, District of Columbia, United States, 20010

University of South Florida

Tampa, Florida, United States, 33606

St. Jude Children's Research Hospital

Memphis, Tennessee, United States, 38105

University of Texas Health Science Center of Houston

Houston, Texas, United States, 77030

Hospital General de Agudos Cosme Argerich

Buenos Aires, Argentina, 1151

Helios Salud

Buenos Aires, Argentina, C1141 ACG

University of the Free State

Bloemfontein, South Africa, 9300

University of Stellenbosch

Cape Town, South Africa, 7505

King Edward VIII Hospital

Durban, South Africa, 3629

Rahima Clinical Trials, a Division of Wits Health Consortium (Pty) Ltd

Johannesburg, South Africa, 2093

The Aurum Institute: Pretoria Clinical Research Centre

Pretoria, South Africa, 87

Perinatal HIV Research Unit

Soweto, South Africa, 2013

HIV-NAT

Bangkok, Thailand, 10330

Siriraj Hospital

Bangkok, Thailand, 10700

Srinagarind Hospital

Khon Kaen, Thailand, 40002

MU-JHU Research Collaboration/MU-JHU Care Ltd

Kampala, Uganda, 256

SICRA-TASO Mulago National Referral Hospital

Kampala, Uganda

AMBSO Masaka Clinical Research Site

Masaka, Uganda

Imperial College Healthcare NHS Trust

London, United Kingdom, W2 1NY

University of Zimbabwe Clinical Research Centre

Harare, Zimbabwe

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