A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments (NCT06337032)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Helios Salud — Buenos Aires
Age range: 1 Month
🧪 Interventions in This Study
- F/TAF (High Dose Tablet) (DRUG)
- F/TAF (Low Dose Tablet) (DRUG)
- F/TAF (Lowest Dose Tablet) (DRUG)
- F/TAF (High Dose TOS) (DRUG)
- F/TAF (Low Dose TOS) (DRUG)
- F/TAF (Lowest Dose TOS) (DRUG)
- E/C/F/TAF (DRUG)
- E/C/F/TAF (Low Dose) (DRUG)
- Cobicistat (High Dose) (DRUG)
- Cobicistat (Low Dose) (DRUG)
- Cobicistat (TOS) (DRUG)
- B/F/TAF (High Dose) (DRUG)
- B/F/TAF (Low Dose) (DRUG)
- B/F/TAF (High Dose TOS) (DRUG)
- B/F/TAF (Low Dose TOS) (DRUG)
- B/F/TAF (Lowest Dose TOS) (DRUG)
- 3rd ARV Agent (DRUG)
- Nucleos(t)ide reverse transcriptase inhibitors (NRTI) (DRUG)
- ATV (DRUG)
- DRV (DRUG)
- Lopinavir Boosted with ritonavir (LPV/r) (DRUG)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (15 Sites)
- Helios Salud — Buenos Aires,
- Hospital del Niño — Panama City,
- University of Stellenbosch — Cape Town,
- Enhancing Care Foundation — Durban,
- WITS RHI Research Centre — Johannesburg,
- Rahima Moosa Mother and Child Hospital — Johannesburg,
- Be Part Yoluntu Centre — Paarl,
- The Aurun Institute — Pretoria,
- Perinatal HIV Research Unit — Soweto,
- Faculty of Medicine - Mahidol University — Bangkok Noi,
- Khon Kaen University — Khon Kaen,
- Joint Clinical Research Centre — Kampala,
- MU-JHU Research Collaboration/MU-JHU Care Ltd — Kampala,
- Baylor College of Medicine — Kampala,
- University of Zimbabwe Clinical Research Centre — Harare,
📞 Contact the Study Coordinator
Phone: 1-833-445-3230 (GILEAD-0)
Email: GileadClinicalTrials@gilead.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in HIV-1-infection
- Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1 — Washington D.C., District of Columbia
- Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen — Berkeley, California
- Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1 — Birmingham, Alabama
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- Study of Oral Weekly Lepetegravir (Formerly GS-1720) and Lenacapavir Pacfosacil (Formerly GS-4182) Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed — Birmingham, Alabama
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.