Providing ongoing access to HIV treatment for children and adolescents

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Gilead Clinical Study Information Center
• Email: GileadClinicalTrials@gilead.com
• Phone: 1-833-445-3230 (GILEAD-0)

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• HIV in Hong Kong: patterns, transmission, and burden over time

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• RNA-based vaccine BNT168 safety and immune response in adults with or without HIV

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.