NCT04150068

Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With an Optimized Background Regimen (OBR) in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug Resistance

A Phase 2/3 Study to Evaluate the Safety and Efficacy of Long-Acting Capsid Inhibitor GS-6207 in Combination With an Optimized Background Regimen in Heavily Treatment Experienced People Living With HIV-1 Infection With Multidrug Resistance

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the antiviral activity of lenacapavir (formerly GS-6207) administered as an add-on to a failing regimen for 14 days (functional monotherapy) in people with human immunodeficiency virus type 1 (HIV-1) (PWH) with multi-drug resistance (MDR).

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
DRUG	Oral Lenacapavir	Tablets administered without regard to food
DRUG	Oral Lenacapavir Placebo	Tablets administered without regard to food
DRUG	Subcutaneous Lenacapavir	Administered in the abdomen via subcutaneous injections
DRUG	Failing ARV Regimen	Failing antiretroviral (ARV) regimen defined by the lack of efficacy. Any combination of approved and unapproved agents that could potentially be part of the failing regimen.
DRUG	Optimized Background Regimen (OBR)	Optimized background regimen as prescribed by the Investigator

Timeline

• Start date: 2019-11-21
• Primary completion: 2020-10-05
• Completion: 2027-01-01
• First posted: 2019-11-04
• Last updated: 2026-03-13
• Results posted: 2021-10-20

Locations

75 sites across 11 countries: United States, Canada, Dominican Republic, France, Germany, Italy, Japan, South Africa, Spain, Taiwan, Thailand

Regulatory

• FDA-regulated drug study