At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Oral Lenacapavir, Oral Lenacapavir Placebo, and 3 other interventions for HIV-1-infection. Active but no longer recruiting, targeting 72 participants across 75 sites in 11 countries.
Detailed 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).
Study Details
Timeline
Interventions
Tablets administered without regard to food
Tablets administered without regard to food
Administered in the abdomen via subcutaneous injections
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.
Optimized background regimen as prescribed by the Investigator