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Protease Inhibitor

HIV Medications for Children With HIV

Phase 2 & 3

Recruiting

Research Sponsored by Gilead Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

HIV-1 infected, virologically suppressed males and females Age ≥ 4 weeks to < 18 years

Participants enrolled prior to implementation of Amendment 7: 2 NRTIs and ATV/r once daily or DRV/r once daily or twice daily

Timeline

Screening 3 weeks

Treatment Varies

Follow Up predose on day 1, and postdose up to week 48

Awards & highlights

No Placebo-Only Group

Summary

This trial will investigate the safety and pharmacokinetics of two HIV medications, Atazanavir and Darunavir, in children and adolescents.

Who is the study for?

This trial is for children aged ≥4 weeks to <18 years with HIV who weigh between ≥3 kg and <40 kg, depending on the cohort. They must have stable antiretroviral regimens for at least 3 months, adequate kidney function, and no resistance to study drugs. Children under 14 kg with certain mutations are allowed if their viral load is low.

What is being tested?

The study tests the safety and dosing of cobicistat-boosted Atazanavir (ATV/co), cobicistat-boosted Darunavir (DRV/co), and Emtricitabine/Tenofovir Alafenamide (F/TAF) in kids with HIV. It involves switching participants from their current treatments to these new drug combinations.

What are the potential side effects?

Possible side effects may include digestive issues, liver problems, allergic reactions, changes in body fat distribution or bone density due to long-term use of HIV medications. Specific side effects related to each drug will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am under 18, HIV positive, and my viral load is low.

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I was treated with specific HIV medications before a certain study change.

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My kidneys are functioning well, with an eGFR of 90 or higher.

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I have no resistance to the study drugs FTC, TFV, ATV, DRV, or LPV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ predose on day 1, and postdose up to week 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~predose on day 1, and postdose up to week 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and predose on day 1, and postdose up to week 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

PK Parameter: AUClast of TAF, FTC and TFV

PK Parameter: AUCtau of COBI and FTC

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

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

10Treatment groups

Experimental Treatment

Group I: Cohort 5 (Group 3)Experimental Treatment2 Interventions

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.

Group II: Cohort 5 (Group 2)Experimental Treatment2 Interventions

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.

Group III: Cohort 5 (Group 1)Experimental Treatment2 Interventions

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.

Group IV: Cohort 4 (Group 4)Experimental Treatment4 Interventions

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.

Group V: Cohort 4 (Group 3)Experimental Treatment4 Interventions

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.

Group VI: Cohort 4 (Group 2)Experimental Treatment4 Interventions

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.

Group VII: Cohort 4 (Group 1)Experimental Treatment5 Interventions

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.

Group VIII: Cohort 3Experimental Treatment4 Interventions

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

Group IX: Cohort 2Experimental Treatment4 Interventions

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.

Group X: Cohort 1: Part A and Part BExperimental Treatment4 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

DRV

2015

Completed Phase 3

~1400

2009

Completed Phase 1

~40

LPV/r