AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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

RecruitingPhase 4Ages 1 Month - anyAllGilead Sciences
💬

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Key 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. Key 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.
💊

What it tests

  • F/TAF (High Dose Tablet)
  • F/TAF (Low Dose Tablet)
  • F/TAF (Lowest Dose Tablet)
  • F/TAF (High Dose TOS)
  • F/TAF (Low Dose TOS)
📍

Where

15 sites
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

…and 7 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy