drugset / Trial / NCT06337032

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

NCT06337032 ↗

Phase 4 Recruiting 350 enrolled Gilead Sciences
Non-randomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2024-08-27
Primary completion
2034-03
Completion
2034-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Abacavir Other / unclassified — —
Subject Atazanavir Other / unclassified — —
Subject B/F/TAF Unknown — Oral
Subject Cobicistat Small molecule 30 mg Oral
Subject Cobicistat Small molecule 90 mg Oral
Subject Cobicistat Small molecule 150 mg Oral
Subject Darunavir Small molecule — —
Subject Didanosine Small molecule — —
Subject Dolutegravir Other / unclassified — —
Subject E/C/F/TAF Unknown — Oral
Subject Efavirenz Other / unclassified — —
Subject F/TAF Unknown — Oral
Subject Lamivudine Other / unclassified — —
Subject Lopinavir Boosted with ritonavir (LPV/r) Unknown — —
Subject Nevirapine Small molecule — —
Subject Raltegravir Other / unclassified — —
Subject Stavudine Other / unclassified — —
Subject Tenofovir disoproxil fumarate Small molecule — —
Subject Zidovudine Small molecule — —
Subject emtricitabine Other / unclassified — —
Subject tenofovir alafenamide Small molecule — —