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A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments

StatusRecruiting
PhasePhase 4
Started2024-08-27
View on ClinicalTrials.gov ↗

Amendment history

2026-09-08
Study Status, Contacts/Locations v13
Study sitesdetails revised at 2 of 15 sites
2026-06-09
Study Status, Contacts/Locations v12
Study sites14→15
2026-03-13
Study Identification, Study Status, Eligibility, Contacts/Locations v11
Eligibility criteria-31 characters
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, 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 havewith plasma HIV RNA ≥ 50 copies/mL during the last parent study [...] ≥ 50 copies/mL). Individuals planning to switch to B/F/TAF must not havewith any ongoing Grade 3 or 4 drug-related AE or clinically rele [...]
Study sitesdetails revised at 4 of 14 sites
2025-11-03
Study Status, Contacts/Locations v10
Study sites12→14
2025-05-15
Study Status, Contacts/Locations v9
Study sites11→12
Show 8 earlier versions
2025-02-26
Study Status, Contacts/Locations v8
Study sites9→11
2025-02-03
Study Status, Contacts/Locations v7
Study sites7→9
2024-12-20
Study Status, Contacts/Locations v6
Study sites6→7
2024-11-07
Study Status, Contacts/Locations v5
Study sites1→6
2024-09-12
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-08→confirmed 2024-08-27
Study sites0→1
2024-08-13
Study Status v3
Re-verified, no change to tracked fields
2024-07-15
Study Status, Eligibility v2
Start date2024-09→2024-08
2024-05-13
Study Status, References v1
2024-03-22
Original filing
Gilead Sciences
107 trials monitored
See 8 trials at risk
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.
Trial Details
NCT Number NCT06337032
Lead Sponsor Gilead Sciences
Conditions HIV-1-infection
Enrollment 350 participants
Start Date 2024-08-27
Primary Completion 2034-03 (estimated)
Study Completion 2034-03 (estimated)
Updated on ClinicalTrials.gov 2026-09-09