NCT06749054

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

A Phase 2, Open-label, Single-Arm Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of Long-Acting Lenacapavir in Combination With an Optimized Background Regimen in Treatment-experienced Adolescents and Children With HIV-1

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
DRUG	Oral Lenacapavir	Tablets administered without regard to food
DRUG	Subcutaneous Lenacapavir	Administered via subcutaneous injections
DRUG	Optimized Background Regimen (OBR)	Optimized background regimen as prescribed by the Investigator

Timeline

• Start date: 2025-03-26
• Primary completion: 2026-10-01
• Completion: 2027-04-01
• First posted: 2024-12-27
• Last updated: 2025-12-02

Locations

9 sites across 2 countries: United States, South Africa

Regulatory

• FDA-regulated drug study