NCT06337032 A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
| NCT ID | NCT06337032 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Gilead Sciences |
| Condition | HIV-1-infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 350 participants |
| Start Date | 2024-08-27 |
| Primary Completion | 2034-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 350 participants in total. It began in 2024-08-27 with a primary completion date of 2034-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Gilead Clinical Study Information Center
✉ GileadClinicalTrials@gilead.com📞 1-833-445-3230 (GILEAD-0)
Gilead Study Director
STUDY DIRECTOR
Gilead Sciences
Frequently Asked Questions
Who can join the NCT06337032 clinical trial?
This trial is open to participants of all sexes, aged 1 Month or older, studying HIV-1-infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06337032 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06337032 currently recruiting?
Yes, NCT06337032 is actively recruiting participants. Contact the research team at GileadClinicalTrials@gilead.com for enrollment information.
Where is the NCT06337032 trial being conducted?
This trial is being conducted at Buenos Aires, Argentina, Panama City, Panama, Cape Town, South Africa, Durban, South Africa and 10 additional locations.
Who is sponsoring the NCT06337032 clinical trial?
NCT06337032 is sponsored by Gilead Sciences. The principal investigator is Gilead Study Director at Gilead Sciences. The trial plans to enroll 350 participants.
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