A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: F/TAF (High Dose Tablet), F/TAF (Low Dose Tablet), F/TAF (Lowest Dose Tablet), F/TAF (High Dose TOS).
- Who it may be relevant to
- Registry conditions: HIV-1-infection. Basic parameters: from 1 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Argentina, Panama, South Africa, Thailand, Uganda +1
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- 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
Primary outcome measures
- Number of Eligible Participants Who Have Received Access to the Study Drug(s) in the Study [Time frame: Up to 9.5 Years]
Secondary outcome measures (1)
- Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) [Time frame: Up to 9.5 Years]
Eligibility criteria
Inclusion criteria
- Completed an applicable parent study: GS-US-292-0106, GS-US-380-1474, GS-US-311-1269, or GS-US-216-0128, and gave consent to study participation.
Exclusion criteria
- Individuals planning to switch to B/F/TAF on Day 1 with plasma HIV RNA ≥ 50 copies/mL during the last parent study visit prior to screening/Day 1 visit.
- Note: individuals planning to switch after Day 1 must not have plasma HIV RNA ≥ 50 copies/mL (or detectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL).
- Individuals planning to switch to B/F/TAF with any ongoing Grade 3 or 4 drug-related AE or clinically relevant Grade 3 or 4 drug-related laboratory abnormality (confirmed on repeat) related to any component of B/F/TAF prior to treatment switch.
- For those on B/F/TAF or planning to switch to B/F/TAF: previous treatment discontinuation of any component of B/F/TAF due to toxicity or intolerance.
- For those planning to switch to B/F/TAF: known hypersensitivity to any component of the study drug, its metabolites, or formulation excipients.
- Ongoing treatment with or prior use of any prohibited medications.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Africa · 7 centers
- University of Stellenbosch — Cape Town
- Enhancing Care Foundation — Durban
- WITS RHI Research Centre — Johannesburg
- Rahima Moosa Mother and Child Hospital — Johannesburg
- Be Part Yoluntu Centre — Paarl
- The Aurun Institute — Pretoria
- Perinatal HIV Research Unit — Soweto
Uganda · 3 centers
- Joint Clinical Research Centre — Kampala
- MU-JHU Research Collaboration/MU-JHU Care Ltd — Kampala
- Baylor College of Medicine — Kampala
Thailand · 2 centers
- Faculty of Medicine - Mahidol University — Bangkok Noi
- Khon Kaen University — Khon Kaen
Argentina · 1 center
- Helios Salud — Buenos Aires
Panama · 1 center
- Hospital del Niño — Panama City
Zimbabwe · 1 center
- University of Zimbabwe Clinical Research Centre — Harare
Identifiers
NCT: NCT06337032 · GS-US-380-6684 · 2024-000521-40