Overview

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.