NCT06544733

Study of Oral Weekly Lepetegravir (Formerly GS-1720) and Lenacapavir Pacfosacil (Formerly GS-4182) Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed

An Operationally Seamless Phase 2/3, Randomized, Active-Controlled Study Evaluating the Safety and Efficacy of an Oral Weekly Regimen of GS-1720 in Combination With GS-4182 Versus Biktarvy in Virologically Suppressed People With HIV-1

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 675 (estimated)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical study is to learn more about the experimental drugs lepetegravir and lenacapavir pacfosacil; to compare the combination of lepetegravir and lenacapavir pacfosacil with the current standard-of-care treatment bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF, BVY), to see if the combination of lepetegravir and lenacapavir pacfosacil is safe and if it works for treating human immunodeficiency virus type 1 (HIV-1) infection. This study has two phases: Phase 2 and Phase 3. The primary objectives of this study are: Phase 2: To evaluate the efficacy of switching to oral weekly lepetegravir in combination with lenacapavir pacfosacil versus continuing BVY in virologically suppressed people with HIV-1 (PWH) at Week 24. Phase 3: To evaluate the efficacy of switching to oral weekly lepetegravir /lenacapavir pacfosacil Fixed-dose combination (FDC) tablet regimen versus continuing BVY in virologically suppressed PWH at Week 48.

Conditions

• HIV-1-Infection

Interventions

Type	Name	Description
DRUG	Lepetegravir	Tablets administered orally without regard to food
DRUG	Lenacapavir pacfosacil	Tablets administered orally without regard to food
DRUG	Placebo to Match BVY	Tablets administered orally without regard to food
DRUG	Bictegravir/emtricitabine/tenofovir alafenamide	Tablets administered orally without regard to food
DRUG	Lepetegravir/Lenacapavir pacfosacil FDC	Tablets administered orally without regard to food
DRUG	Placebo to Match GS1720/GS-4182 FDC	Tablets administered orally without regard to food

Timeline

• Start date: 2024-08-20
• Primary completion: 2028-01-01
• Completion: 2029-06-01
• First posted: 2024-08-09
• Last updated: 2026-04-17

Locations

39 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study