Study of Long-Acting Lenacapavir with Other Medicines to Treat HIV-1 in Children and Adolescents Who Have Received Previous Treatment

What this Trial Is About

Researchers are evaluating lenacapavir LEN, a long-acting study drug, combined with other medicines for treating adolescents and children living with HIV-1 who weigh at least 35 kg and have prior treatment experience. The study aims to assess the safety, tolerability, and pharmacokinetics of LEN when used with an optimized background regimen OBR in this population. It also explores how easy it is for participants to take LEN either as an injection or an oral pill. Participants will start by taking oral LEN tablets 600 mg on Days 1 and 2. They will also receive two doses of LEN 927 mg as subcutaneous injections on Day 1 and at Week 26, alongside their usual OBR treatment. At Week 52, participants may choose to continue receiving subcutaneous LEN injections every six months for at least two more doses during an extension phase, while maintaining their OBR. During the study, researchers will monitor participants closely through blood tests to measure LEN levels and assess safety, including any treatment-emergent side effects or laboratory abnormalities, up to Week 52. They will also evaluate how well the virus is controlled by measuring plasma HIV-1 RNA levels and changes in CD4 cell counts. Participants will complete questionnaires about their experience with oral LEN, and safety and tolerability will be observed throughout the treatment and extension periods, which may last beyond one year.

Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and Children