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

NCT02016924 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: GS-US-216-01282013-001402-28IS000883
• Study Type: interventional
• Target: 133
• Locations: 7 countries
• Sites: 23

Brief 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.

Conditions

Acquired Immune Deficiency Syndrome (AIDS); HIV Infections

Keywords

Pediatrics; Adolescents; HIV; HIV-1; Treatment experienced

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetic (PK) Parameter: AUCtau of ATV, DRV, TAF, and TFV

  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.

  Predose on Day 1, and postdose up to Week 48

• 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)

Secondary Outcomes (16)

• PK Parameter: Ctau of ATV, DRV, COBI, FTC and TFV

  Predose on Day 1, and postdose up to Week 48

• PK Parameter: Cmax of ATV, DRV, COBI, TAF, FTC and TFV

  Predose on Day 1, and postdose up to Week 48

• PK Parameter: CL/F of ATV, DRV, COBI, TAF, FTC and TFV

  Predose on Day 1, and postdose up to Week 48

• PK Parameter: Vz/F of COBI, TAF, FTC and TFV

  Predose on Day 1, and postdose up to Week 48

• PK Parameter: AUCtau of COBI and FTC

  Predose on Day 1, and postdose up to Week 48

Study Arms (10)

Cohort 1: Part A and Part B

EXPERIMENTAL

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.

Drug: ATV; Drug: DRV; Drug: Cobicistat; Drug: BR

Cohort 2

EXPERIMENTAL

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.

Drug: ATV; Drug: DRV; Drug: Cobicistat; Drug: F/TAF

Cohort 3

EXPERIMENTAL

Participants age ≥ 2 years old will receive cobicistat 90 mg and F/TAF 120/15 mg with either ATV or DRV.

Drug: ATV; Drug: DRV; Drug: Cobicistat; Drug: F/TAF

Cohort 4 (Group 1)

EXPERIMENTAL

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.

Drug: ATV; Drug: DRV; Drug: LPV/r; Drug: Cobicistat TOS; Drug: F/TAF TOS

Cohort 4 (Group 2)

EXPERIMENTAL

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.

Drug: ATV; Drug: LPV/r; Drug: Cobicistat TOS; Drug: F/TAF TOS

Cohort 4 (Group 3)

EXPERIMENTAL

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.

Drug: ATV; Drug: LPV/r; Drug: Cobicistat TOS; Drug: F/TAF TOS

Cohort 4 (Group 4)

EXPERIMENTAL

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.

Drug: ATV; Drug: LPV/r; Drug: Cobicistat TOS; Drug: F/TAF TOS

Cohort 5 (Group 1)

EXPERIMENTAL

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.

Drug: Third Unboosted Drug; Drug: F/TAF TOS

Cohort 5 (Group 2)

EXPERIMENTAL

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.

Drug: Third Unboosted Drug; Drug: F/TAF TOS

Cohort 5 (Group 3)

EXPERIMENTAL

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.

Drug: Third Unboosted Drug; Drug: F/TAF TOS

Interventions

ATV DRUG

Capsules administered once daily according to dosing recommendations per product monograph

Also known as: Reyataz®

Cohort 1: Part A and Part B; Cohort 2; Cohort 3; Cohort 4 (Group 1); Cohort 4 (Group 2); Cohort 4 (Group 3); Cohort 4 (Group 4)

DRV DRUG

Tablets administered once daily according to dosing recommendations per product monograph

Also known as: Prezista®

Cohort 1: Part A and Part B; Cohort 2; Cohort 3; Cohort 4 (Group 1)

Cobicistat DRUG

Tablets administered orally once daily with food

Also known as: GS-9350, Tybost®

Cohort 1: Part A and Part B; Cohort 2; Cohort 3

BR DRUG

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 1: Part A and Part B

F/TAF DRUG

Tablets administered orally once daily

Also known as: Descovy®

Cohort 2; Cohort 3

LPV/r DRUG

Solution administered orally

Cohort 4 (Group 1); Cohort 4 (Group 2); Cohort 4 (Group 3); Cohort 4 (Group 4)

Third Unboosted Drug DRUG

ATV (administered orally), DRV (administered orally), and LPV/r (administered orally) would be general list but unspecified for sites.

Cohort 5 (Group 1); Cohort 5 (Group 2); Cohort 5 (Group 3)

Cobicistat TOS DRUG

Tablets for oral suspension

Also known as: GS-9350, Tybost®

Cohort 4 (Group 1); Cohort 4 (Group 2); Cohort 4 (Group 3); Cohort 4 (Group 4)

F/TAF TOS DRUG

Tablets for oral suspension

Also known as: Descovy®

Cohort 4 (Group 1); Cohort 4 (Group 2); Cohort 4 (Group 3); Cohort 4 (Group 4); Cohort 5 (Group 1); Cohort 5 (Group 2); Cohort 5 (Group 3)

Eligibility Criteria

• Age: 4 Weeks - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (23)

Pediatric Infectious Disease Associates

Long Beach, California, 90806, United States

Location

Peter Morton Medical Building

Los Angeles, California, 90095, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

The George Washington University

Washington D.C., District of Columbia, 20010, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

University of Texas Health Science Center of Houston

Houston, Texas, 77030, United States

Location

Hospital General de Agudos Cosme Argerich

Buenos Aires, 1151, Argentina

Location

Helios Salud

Buenos Aires, C1141 ACG, Argentina

Location

University of the Free State

Bloemfontein, 9300, South Africa

Location

University of Stellenbosch

Cape Town, 7505, South Africa

Location

King Edward VIII Hospital

Durban, 3629, South Africa

Location

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

Johannesburg, 2093, South Africa

Location

The Aurum Institute: Pretoria Clinical Research Centre

Pretoria, 87, South Africa

Location

Perinatal HIV Research Unit

Soweto, 2013, South Africa

Location

HIV-NAT

Bangkok, 10330, Thailand

Location

Siriraj Hospital

Bangkok, 10700, Thailand

Location

Srinagarind Hospital

Khon Kaen, 40002, Thailand

Location

MU-JHU Research Collaboration/MU-JHU Care Ltd

Kampala, 256, Uganda

Location

SICRA-TASO Mulago National Referral Hospital

Kampala, Uganda

Location

AMBSO Masaka Clinical Research Site

Masaka, Uganda

Location

Imperial College Healthcare NHS Trust

London, W2 1NY, United Kingdom

Location

University of Zimbabwe Clinical Research Centre

Harare, Zimbabwe

Location

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; HIV Infections

Interventions

Atazanavir Sulfate; Darunavir; Cobicistat; emtricitabine tenofovir alafenamide

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Sulfonamides; Amides; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Thiazoles; Azoles

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2013
• First Posted: December 20, 2013
• Study Start: January 16, 2014
• Primary Completion: June 13, 2025
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

TH (3); AR (2); GB (1); ZA (6); US (7); UG (3); ZI (1)