Providing ongoing access to HIV treatment for children and adolescents
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
This study is testing whether children and teens with HIV can keep getting their treatment or switch to a new combination therapy to ensure they stay healthy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 1 Month and up |
| Sex | All |
| Sponsor | Gilead Sciences Industry-sponsored |
| Locations | 14 sites (Buenos Aires and 13 other locations) |
| Trial ID | NCT06337032 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to provide continued access to HIV treatment for children and adolescents who have completed prior studies involving Gilead's HIV medications. Participants will either continue with the study drug they were receiving or switch to a new combination therapy of bictegravir/emtricitabine/tenofovir (B/F/TAF). The study will also monitor participants for any adverse events related to the treatment. The focus is on ensuring that young patients maintain access to effective HIV therapies.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents who have completed a relevant parent study and consented to participate in this continued access program.
Not a fit: Patients who have detectable HIV-1 RNA levels or significant drug-related adverse events may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could ensure that children and adolescents with HIV-1 have uninterrupted access to effective treatment options.
How similar studies have performed: Other studies have shown success in providing continued access to HIV treatments, indicating a positive precedent for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Buenos Aires and 13 other locations
- Helios Salud — Buenos Aires, Argentina (Active_not_recruiting)
- Hospital del Niño — Panama City, Panama (Active_not_recruiting)
- University of Stellenbosch — Cape Town, South Africa (Recruiting)
- Enhancing Care Foundation — Durban, South Africa (Recruiting)
- WITS RHI Research Centre — Johannesburg, South Africa (Recruiting)
- Rahima Moosa Mother and Child Hospital — Johannesburg, South Africa (Recruiting)
- Be Part Yoluntu Centre — Paarl, South Africa (Recruiting)
- The Aurun Institute — Pretoria, South Africa (Recruiting)
- Perinatal HIV Research Unit — Soweto, South Africa (Recruiting)
- Faculty of Medicine - Mahidol University — Bangkok Noi, Thailand (Active_not_recruiting)
- Khon Kaen University — Khon Kaen, Thailand (Active_not_recruiting)
- Joint Clinical Research Centre — Kampala, Uganda (Recruiting)
- Baylor College of Medicine — Kampala, Uganda (Recruiting)
- University of Zimbabwe Clinical Research Centre — Harare, Zimbabwe (Recruiting)
Study contacts
- Study coordinator: Gilead Clinical Study Information Center
- Email: GileadClinicalTrials@gilead.com
- Phone: 1-833-445-3230 (GILEAD-0)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.