Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion

Description

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 living with HIV (PLWH) with multi-drug resistance (MDR).

Official Title

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

Keywords

HIV-1-infection Infection Communicable Diseases HIV Infections Oral Lenacapavir Subcutaneous Lenacapavir Failing ARV Regimen Optimized Background Regimen (OBR)

Eligibility

You can join if…

Open to people ages 12 years and up

  • 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 antiretroviral (ARV) regimen for > 8 weeks
  • Have HIV-1 RNA ≥ 400 copies/mL at screening
  • Have multidrug resistance
  • 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 optimized background regimen together with lenacapavir
  • No Hepatitis C virus (HCV) ongoing infection

Note: Other protocol defined Inclusion/

You CAN'T join if...

may apply.

Locations

  • One Community Health accepting new patients
    Sacramento California 95817 United States
  • Mills Clinical Research accepting new patients
    Los Angeles California 90069 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
Links
Sign up for this study
ID
NCT04150068
Phase
Phase 2/3
Study Type
Interventional
Last Updated