Continued Access to HIV Treatments for Children and Adolescents Who Completed Pediatric Gilead HIV Drug Studies

What this Trial Is About

This research aims to provide continued access to HIV-1 treatment drugs for children and adolescents who have completed relevant prior studies involving Gilead Sciences HIV therapies. It evaluates the safety of these study drugs in participants living with HIV-1, offering a way to maintain their treatment while monitoring for any adverse events. The study is open-label and single-arm, focusing on participants who previously took part in specific parent studies. Participants will continue taking the study drug they received in their parent study, which may include combinations such as emtricitabinetenofovir alafenamide FTAF with a third antiretroviral agent, elvitegravircobicistatemtricitabinetenofovir alafenamide ECFTAF, or other combinations involving cobicistat and protease inhibitors. Dosages are adjusted based on participant weight, and some may switch to bictegraviremtricitabinetenofovir BFTAF depending on their situation. The study drugs are administered orally in various fixed-dose tablets or oral suspension forms. During the study, participants will be monitored for up to 9.5 years to track access to the study drugs and observe any treatment-emergent adverse events. The evaluation includes regular safety monitoring to assess how participants tolerate continued treatment. The long-term observation ensures ongoing assessment of drug safety and participant health throughout the study duration.

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