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

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.

Eligibility

Age range

Up to 17 years

Sex

All

Healthy volunteers

No

Interventions

• 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

Locations (9)