Overview
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
Key Inclusion Criteria:
- Completed an applicable parent study: GS-US-292-0106, GS-US-380-1474, GS-US-311-1269, GS-US-216-0128, or CO-US-380-5578 and gave consent to study participation.
Key Exclusion Criteria:
- Individuals planning to switch to B/F/TAF on Day 1 cannot have 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 must not have 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.