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Study identifier: NCT06749054 Synced from ClinicalTrials.gov · July 30, 2026
● Recruiting

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

Condition: HIV-1-infection  ·  Sponsor: Gilead Sciences

PhasePhase 2
Planned participants12
Who can joinAll sexes, N/A to 17 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Gilead Clinical Study Information Center  ·  1-833-445-3230 (GILEAD-0)  ·  GileadClinicalTrials@gilead.com

Always discuss trial participation with your own doctor first.

Locations (9)

Grady Health System, Ponce De Leon CenterAtlanta, Georgia, United StatesRecruiting
FAMCRUCape Town, South AfricaRecruiting
CRISMO Research CentreGermiston, South AfricaRecruiting
Wits RHI Shandukani Research Centre CRSJohannesburg, South AfricaRecruiting
Rahima Moosa Mother and Child HospitalJohannesburg, South AfricaRecruiting
Clinical Research Institute of South Africa (CRISA)KwaDukuza, South AfricaRecruiting
Durban International Clinical Research Site, Enhancing Care FoundationKwaZulu - Natal, South AfricaRecruiting
Be Part Research Pty (Ltd)Paarl, South AfricaRecruiting
Perinatal HIV Research Unit (PHRU)Soweto, South AfricaWithdrawn

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Source record: clinicaltrials.gov/study/NCT06749054