NCT06337032

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 1 Month
• Healthy volunteers: Not accepted

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.

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
DRUG	F/TAF (High Dose Tablet)	200/25 mg fixed-dose combination (FDC) tablet administered orally
DRUG	F/TAF (Low Dose Tablet)	200/10 mg FDC tablet administered orally
DRUG	F/TAF (Lowest Dose Tablet)	120/15 mg FDC tablet administered orally
DRUG	F/TAF (High Dose TOS)	60/7.5 mg tablet for oral suspension (TOS) administered orally
DRUG	F/TAF (Low Dose TOS)	30/3.75 mg TOS administered orally
DRUG	F/TAF (Lowest Dose TOS)	15/1.88 mg TOS administered orally
DRUG	E/C/F/TAF	150/150/200/10 mg tablet administered orally
DRUG	E/C/F/TAF (Low Dose)	90/90/120/6 mg tablet administered orally
DRUG	Cobicistat (High Dose)	150 mg tablet administered orally
DRUG	Cobicistat (Low Dose)	90 mg tablet administered orally
DRUG	Cobicistat (TOS)	30 mg TOS administered orally
DRUG	B/F/TAF (High Dose)	50/200/25 mg FDC tablet administered orally
DRUG	B/F/TAF (Low Dose)	30/120/15 mg FDC tablet administered orally
DRUG	B/F/TAF (High Dose TOS)	15/60/7.52 mg TOS administered orally
DRUG	B/F/TAF (Low Dose TOS)	7.5/30/3.76 mg TOS administered orally
DRUG	B/F/TAF (Lowest Dose TOS)	3.76/15/1.88 mg TOS administered orally
DRUG	3rd 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
DRUG	Nucleos(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)
DRUG	ATV	Administered according to the prescribing information
DRUG	DRV	Administered according to the prescribing information
DRUG	Lopinavir Boosted with ritonavir (LPV/r)	Administered according to the prescribing information

Timeline

• Start date: 2024-08-27
• Primary completion: 2034-03-01
• Completion: 2034-03-01
• First posted: 2024-03-29
• Last updated: 2026-03-16

Locations

14 sites across 6 countries: Argentina, Panama, South Africa, Thailand, Uganda, Zimbabwe

Regulatory

• FDA-regulated drug study