Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 4interventionalRules rewrite

Phase 4: testing F/TAF (High Dose Tablet) for HIV-1-infection

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 side effects. 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.

Official registry: https://clinicaltrials.gov/study/NCT06337032 · Gilead Sciences · enrollment listed as 350

What this phase means

Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are F/TAF (High Dose Tablet), F/TAF (Low Dose Tablet), or F/TAF (Lowest Dose Tablet). The registry lists allocation as randomized. 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 side effects.

They plan to enroll about 350 people at 17 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: 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), F/TAF (Lowest Dose TOS), E/C/F/TAF, E/C/F/TAF (Low Dose), Cobicistat (High Dose), Cobicistat (Low Dose), Cobicistat (TOS), B/F/TAF (High Dose), B/F/TAF (Low Dose), B/F/TAF (High Dose TOS), B/F/TAF (Low Dose TOS), B/F/TAF (Lowest Dose TOS), 3rd ARV Agent, Nucleos(t)ide reverse transcriptase inhibitors (NRTI), ATV, DRV, Lopinavir Boosted with ritonavir (LPV/r)

Primary outcome (registry wording): Number of Eligible Participants Who Have Received Access to the Study Drug(s) in the Study

Who it is for (from inclusion criteria)

  • Ages 1 Month to any
  • 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

Public study contact (from the registry)

Gilead Clinical Study Information Center

1-833-445-3230 (GILEAD-0)

GileadClinicalTrials@gilead.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

17 listed

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NCT00039689 · Official ClinicalTrials.gov record · National Institute of Allergy and Infectious Diseases (NIAID)

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NCT00789009 · Official ClinicalTrials.gov record · National Institute of Allergy and Infectious Diseases (NIAID)

FAQ about this NCT record

Is NCT06337032 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06337032?

Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06337032?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary