NCT05052996

Study Evaluating the Safety and Efficacy of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV

A Phase 2 Randomized, Open-Label, Active-Controlled Study Evaluating the Safety and Efficacy of an Oral Weekly Regimen of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the efficacy of oral weekly islatravir (ISL) in combination with lenacapavir (LEN) in virologically suppressed people with HIV (PWH) at Week 24.

Conditions

• HIV-1 Infection

Interventions

Type	Name	Description
DRUG	ISL	Capsules administered orally without regard to food
DRUG	LEN	Tablets administered orally without regard to food
DRUG	B/F/TAF	Tablets administered orally without regard to food
DRUG	ISL/LEN FDC	Tablets administered orally without regard to food

Timeline

• Start date: 2021-10-05
• Primary completion: 2023-12-19
• Completion: 2028-03-01
• First posted: 2021-09-22
• Last updated: 2026-02-04
• Results posted: 2025-01-14

Locations

44 sites across 1 country: United States

Regulatory

• FDA-regulated drug study