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

  • End date
    Oct 29, 2023
  • participants needed
  • sponsor
    Gilead Sciences
Updated on 11 November 2020
Gilead Study Team
Primary Contact
Washington Health Institute (3.3 mi away) Contact
+75 other location


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).

Treatment Optimized Background Regimen (OBR), Placebo Oral Tablet, Oral GS-6207, Subcutaneous GS-6207, Failing ARV Regimen, Oral Lenacapavir, Subcutaneous Lenacapavir
Clinical Study IdentifierNCT04150068
SponsorGilead Sciences
Last Modified on11 November 2020

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Inclusion Criteria

Is your age greater than or equal to 12 yrs?
Gender: Male or Female
Do you have HIV-1-infection?
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/Exclusion criteria may apply
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