Continued drug access for children with HIV who finished Gilead studies
Gives continued study medicine to children and teens with HIV who completed earlier studies.
Plain-language title generated from the registry record
Registry title: A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
Key facts
- Where
- Panama City, PanamaSee the site
- Phase
- Phase 4
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and adolescents with HIV-1 who finished one of the listed Gilead parent studies. It gives continued access to the study drug and checks safety.
- Age
- From 1 Month of age.
- Sex
- All sexes can join.
- Disease stage
- HIV-1 infection; no particular stage is named.
- Earlier treatment
- Must have completed one of these parent studies: GS-US-292-0106, GS-US-380-1474, GS-US-311-1269, or GS-US-216-0128.
- Biomarker or test result
- For switching to B/F/TAF on Day 1, plasma HIV RNA must be below 50 copies/mL at the last parent study visit.
Main reasons for not taking part
- Plans to switch to B/F/TAF on Day 1 with plasma HIV RNA ≥ 50 copies/mL at the last parent study visit
- Plans to switch to B/F/TAF with an ongoing Grade 3 or 4 drug-related adverse event or lab abnormality
- Earlier stop of any B/F/TAF component because of toxicity or intolerance
- Known allergy to a component of the study drug when planning to switch to B/F/TAF
- Ongoing treatment with or earlier use of prohibited medications
Read by machine on 9 November 2026.
Where in Panama
- Hospital del NiñoPanama City, PanamaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Gilead Sciences
- Trial code
- NCT06337032
- Record updated
- 6 November 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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); 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; Ongoing treatment with or prior use of any prohibited medications; Note: Other protocol defined Inclusion/Exclusion criteria may apply; For those planning to switch to B/F/TAF: known hypersensitivity to any component of the study drug, its metabolites, or formulation excipients; 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.