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

• Status: Active, not recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

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 (functional monotherapy) in people with HIV (PWH) with multi-drug resistance (MDR).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences

Criteria

Key Inclusion Criteria:

• Adult aged ≥ 18 years (at all sites) or adolescent aged ≥ 12 and weighing ≥ 35 kg (at sites in North America and Dominican Republic)

• Currently receiving a stable failing ARV regimen for > 8 weeks

• Have HIV-1 RNA ≥ 400 copies/mL at screening

• Have multidrug resistance (resistance to ≥2 agents from ≥3 of the 4 main classes of ARV)

• Have no more than 2 fully active ARV remaining from the 4 main classes that can be effectively combined to form a viable regimen

• Able and willing to receive an OBR together with lenacapavir

• No Hepatitis C virus (HCV) ongoing infection

Note: Other protocol defined Inclusion/Exclusion criteria may apply.