NCT06613685

Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated

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 Treatment-Naive People With HIV-1

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 73 (actual)
• 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 (formerly GS-1720) (an oral, long-acting integrase strand transfer inhibitor (INSTI)) and lenacapavir pacfosacil (formerly GS-4182) (a prodrug of Lenacapavir (LEN)); to compare the combination of lepetegravir and lenacapavir pacfosacil with the current standard-of-care treatment bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (Biktarvy), 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 in treatment-naive people with HIV-1 (PWH). This study has two phases: Phase 2 and Phase 3. The primary objectives of this study are: Phase 2: To evaluate the efficacy of oral weekly lepetegravir coadministered with lenacapavir pacfosacil versus continuing Biktarvy (BVY) in treatment-naive PWH at Week 24. Phase 3: To evaluate the efficacy of oral weekly lepetegravir/lenacapavir pacfosacil fixed-dose combination (FDC) tablet regimen versus continuing BVY in treatment-naive 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	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 BVY	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: 2024-10-21
• Primary completion: 2026-03-16
• Completion: 2026-03-16
• First posted: 2024-09-26
• Last updated: 2026-04-15

Locations

58 sites across 9 countries: United States, Canada, Germany, Poland, Portugal, Puerto Rico, Romania, South Africa, Spain

Regulatory

• FDA-regulated drug study