Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and Children
Recruiting now · Phase 2
Conditions studied: HIV-1-infection
In brief
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.
Key facts
- Study ID
- NCT06749054
- Run by
- Gilead Sciences
- People needed
- 12
- Starts
- 2025-03-26
- Expected to finish
- 2027-09-01
- Last updated by the study team
- 2026-04-24
Who can join
Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Grady Health System, Ponce De Leon Center — Atlanta, Georgia, United States (enrolling)
- FAMCRU — Cape Town, South Africa (enrolling)
- CRISMO Research Centre — Germiston, South Africa (enrolling)
- Wits RHI Shandukani Research Centre CRS — Johannesburg, South Africa (enrolling)
- Rahima Moosa Mother and Child Hospital — Johannesburg, South Africa (enrolling)
- Clinical Research Institute of South Africa (CRISA) — KwaDukuza, South Africa (enrolling)
- Durban International Clinical Research Site, Enhancing Care Foundation — KwaZulu - Natal, South Africa (enrolling)
- Be Part Research Pty (Ltd) — Paarl, South Africa (enrolling)
- Perinatal HIV Research Unit (PHRU) — Soweto, South Africa
Full record on ClinicalTrials.gov
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