Summary

Eligibility
for people ages 18-65 (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 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).

Official Title

A Phase 1b Randomized, Blinded, Proof-of-Concept Study to Evaluate the Safety and Efficacy of Broadly Neutralizing Antibodies (bNAbs) GS-5423 and GS-2872 in Combination With Capsid Inhibitor Lenacapavir (GS-6207) in Virologically Suppressed Adults With HIV-1 Infection

Keywords

HIV-1 Infection Infections Communicable Diseases HIV Infections Oral Lenacapavir Subcutaneous Lenacapavir Lenacapavir (LEN), GS-5423, GS-2872 Dose C LEN, GS-5423, GS-2872 Dose D

Eligibility

You can join if…

Open to people ages 18-65

  • 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

You CAN'T join if...

  • 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.

Locations

  • One Community Health accepting new patients
    Sacramento California 95811 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
NCT04811040
Phase
Phase 1
Study Type
Interventional
Last Updated