Study to Evaluate the Safety and Efficacy of GS-5423 and GS-2872 in Combination With Lenacapavir (GS-6207) in Virologically Suppressed Adults With HIV-1 Infection

• Status: Recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the safety and tolerability of a combination of the broadly neutralizing antibodies (bNAbs) GS-5423 and GS-2872 in combination with the HIV capsid inhibitor lenacapavir (LEN).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences

Criteria

Key Inclusion Criteria:

• On first-line antiretroviral therapy (ART) for ≥ 2 years prior to screening. A change in ART regimen ≥ 28 days prior to screening for reasons other than virologic failure (VF) (eg, tolerability, simplification, drug-drug interaction profile) is allowed

• No documented historical resistance to the current ART regimen

• Plasma HIV-1 RNA < 50 copies/mL at screening

• Documented plasma HIV-1 RNA < 50 copies/mL for ≥ 18 months preceding the screening visit (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL). Unconfirmed virologic elevations of ≥ 50 copies/mL (transient detectable viremia, or "blip") prior to screening are acceptable.

• Proviral phenotypic sensitivity to both GS-5423 and GS-2872 at screening

• CD4+ count nadir ≥ 350 cells/μL

• Screening CD4+ count ≥ 500 cells/μL

• Availability of a fully active alternative ART regimen, in the opinion of the investigator, in the event of discontinuation of the current ART regimen with development of resistance

Key Exclusion Criteria:

• Comorbid condition requiring ongoing immunosuppression

• Evidence of current hepatitis B virus (HBV) infection

• Evidence of current hepatitis C virus (HCV) infection (prior infection cleared spontaneously or with treatment is acceptable)

• History of opportunistic infection or illness indicative of Stage 3 HIV disease

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