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