drugset / Trial / NCT06749054

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

NCT06749054

Phase 2 Recruiting 12 enrolled Gilead Sciences
NaSingle-groupOpen-labelTreatment

Summary

The goal of this clinical study is to learn more about the study drug, lenacapavir (LEN). The study will assess the safety, tolerability, and efficacy of long-acting LEN when combined with other medicines in adolescents and children living with HIV-1 who weigh at least 35 kg and have been treated before for HIV-1. The study will also see how easy it is for participants to take LEN as injection or an oral pill. The primary objectives are to evaluate the pharmacokinetics and safety of LEN in combination with optimized background regimen (OBR) in TE pediatric participants with HIV-1.

Timeline

Start
2025-03-26
Primary completion
2027-03
Completion
2027-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenacapavir Small molecule 927 mg Oral