RecruitingPhase 4NCT06337032

A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments

An Open-label, Single-arm Study to Provide Continued Access to Study Drug to Participants Who Have Completed Pediatric Clinical Studies Involving Gilead HIV Treatments

Sponsor

Gilead Sciences

Enrollment

350 participants

Start Date

Aug 27, 2024

Study Type

INTERVENTIONAL

Conditions

HIV-1-infection

Summary

The goal of this clinical study is to provide continued access to the study drug(s) to children and adolescents with human immunodeficiency virus type 1 (HIV-1) who completed their participation in an applicable parent study and to monitor for adverse events. The primary objectives of this study are as follows: * To provide continued access to the study drug received in the parent protocol or switch to bictegravir/emtricitabine/tenofovir (B/F/TAF) for participants who completed a Gilead parent study evaluating drugs for HIV treatment. * To evaluate the safety of the study drug(s) in participants with HIV-1.

Eligibility

Min Age: 1 Month

Plain Language Summary

Simplified for easier understanding

This study gives children and teenagers with HIV continued access to a Gilead HIV medication (a combination pill called bictegravir/emtricitabine/tenofovir alafenamide, or B/F/TAF) after they finish a previous Gilead HIV clinical trial. **You may be eligible if...** - You are a child or adolescent who completed one of four specific Gilead HIV studies (GS-US-292-0106, GS-US-380-1474, GS-US-311-1269, or GS-US-216-0128) - You gave consent to participate in this follow-up study **You may NOT be eligible if...** - Your HIV levels in the blood are detectable (50 copies/mL or more) at or around the time you would switch to B/F/TAF - You are having moderate to severe side effects from B/F/TAF - You had to stop taking any part of B/F/TAF before because of bad reactions - You are allergic to any ingredient in the study medication - You are taking certain medications that are not allowed in this study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGF/TAF (High Dose Tablet)

200/25 mg fixed-dose combination (FDC) tablet administered orally

DRUGF/TAF (Low Dose Tablet)

200/10 mg FDC tablet administered orally

DRUGF/TAF (Lowest Dose Tablet)

120/15 mg FDC tablet administered orally

DRUGF/TAF (High Dose TOS)

60/7.5 mg tablet for oral suspension (TOS) administered orally

DRUGF/TAF (Low Dose TOS)

30/3.75 mg TOS administered orally

DRUGF/TAF (Lowest Dose TOS)

15/1.88 mg TOS administered orally

DRUGE/C/F/TAF

150/150/200/10 mg tablet administered orally

DRUGE/C/F/TAF (Low Dose)

90/90/120/6 mg tablet administered orally

DRUGCobicistat (High Dose)

150 mg tablet administered orally

DRUGCobicistat (Low Dose)

90 mg tablet administered orally

DRUGCobicistat (TOS)

30 mg TOS administered orally

DRUGB/F/TAF (High Dose)

50/200/25 mg FDC tablet administered orally

DRUGB/F/TAF (Low Dose)

30/120/15 mg FDC tablet administered orally

DRUGB/F/TAF (High Dose TOS)

15/60/7.52 mg TOS administered orally

DRUGB/F/TAF (Low Dose TOS)

7.5/30/3.76 mg TOS administered orally

DRUGB/F/TAF (Lowest Dose TOS)

3.76/15/1.88 mg TOS administered orally

DRUG3rd ARV Agent

A 3rd antiretroviral (ARV) agent administered as defined by the investigator, according to the prescribing information. A 3rd ARV agent may include: boosted atazanavir (ATV), boosted lopinavir (LPV/r), boosted darunavir (DRV), unboosted efavirenz (EFV), unboosted nevirapine (NVP), unboosted raltegravir (RAL), or unboosted dolutegravir (DTG), or any other unspecified agent that is available in a participant's country

DRUGNucleos(t)ide reverse transcriptase inhibitors (NRTI)

NRTIs administered as defined by the investigator, according to the prescribing information. NRTIs may include zidovudine (ZDV), stavudine (d4T), didanosine (ddI), abacavir (ABC), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), lamivudine (3TC), or emtricitabine (FTC)

DRUGATV

Administered according to the prescribing information

DRUGDRV

Administered according to the prescribing information

DRUGLopinavir Boosted with ritonavir (LPV/r)

Administered according to the prescribing information

Locations(14)

Helios Salud

Buenos Aires, Argentina

Hospital del Niño

Panama City, Panama

University of Stellenbosch

Cape Town, South Africa

Enhancing Care Foundation

Durban, South Africa

WITS RHI Research Centre

Johannesburg, South Africa

Rahima Moosa Mother and Child Hospital

Johannesburg, South Africa

Be Part Yoluntu Centre

Paarl, South Africa

The Aurun Institute

Pretoria, South Africa

Perinatal HIV Research Unit

Soweto, South Africa

Faculty of Medicine - Mahidol University

Bangkok Noi, Thailand

Khon Kaen University

Khon Kaen, Thailand

Joint Clinical Research Centre

Kampala, Uganda

Baylor College of Medicine

Kampala, Uganda

University of Zimbabwe Clinical Research Centre

Harare, Zimbabwe

View Full Details on ClinicalTrials.gov

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NCT06337032

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