LAST UPDATED
January 27, 2025
Clinicaltrials.gov ID
OVERVIEW
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
PROTOCOL SUMMARY
The primary objective of this study is to evaluate the safety and tolerability of a combination of the broadly neutralizing antibodies (bNAbs) teropavimab (formerly GS-5423) and zinlirvimab (formerly GS-2872) in combination with the HIV capsid inhibitor lenacapavir (LEN).
View moreParticipation requirements
Age
18 years - 65 years
Sex
All
Healthy Volunteers
No
Age
18 years - 65 years
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
HIV-1 Infection
Gender
N/A
Date
April 2021 - June 2022
Study Type
Interventional
Study Phase
Phase 1
Product
Oral Lenacapavir, Subcutaneous Lenacapavir, Teropavimab, Zinlirvimab
Eligibility information
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 teropavimab and zinlirvimab at screening by the PhenoSense mAb Assay (Monogram Biosciences) for inclusion in the Primary Cohort; sensitivity at screening by the PhenoSense mAb Assay (Monogram Biosciences) to 1 mAb, either teropavimab or zinlirvimab, within 18 months prior to enrollment for inclusion in the optional Pilot Cohort
- \-- In both cohorts, teropavimab sensitivity is defined as 90% inhibitory concentration (IC90) ≤ 2 μg/mL; zinlirvimab sensitivity is defined as IC90 ≤ 2 μg/mL;
- Cluster determinant 4+ (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
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.
Locations
Locations (23)
Ruane Clinical Research Group Inc.
Los Angeles, California, United States, 90036
Mills Clinical Research
Los Angeles, California, United States, 90069
UCSD AntViral Research Center (AVRC)
San Diego, California, United States, 92103
Yale University; School of Medicine; AIDS Program
New Haven, Connecticut, United States, 06510
Midway Immunology and Research Center
Ft. Pierce, Florida, United States, 34982
University of Miami Miller School of Medicine Schiff Center for Liver Disease
Miami, Florida, United States, 33136
Triple O Research Institute, P.A
West Palm Beach, Florida, United States, 33407
Mercer University, Department of Internal Medicine
Macon, Georgia, United States, 31201
Indiana CTSI Clinical Research Center
Indianapolis, Indiana, United States, 46202
National Institutes of Health/Clinical Center
Bethesda, Maryland, United States, 20892
Icahn School of Medicine at Mount Sinai-Clinical and Translational Research Center
New York, New York, United States, 10029
NC TraCS Institute-CTRC; University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
The Brody School of Medicine at East Carolina University, ECU Adult Specialty Care
Greenville, North Carolina, United States, 27834
Rosedale Health & Wellness
Huntersville, North Carolina, United States, 28078
Perelman Center for Advanced Medicine at the Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
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