Study Details

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).

Participation Requirements

Age

18 Years - 65 Years

Sex

ALL

Healthy Volunteers

Medical Condition

HIV-1 Infection

Gender

N/A

Date

April 2021 - June 2022

Study Type

INTERVENTIONAL

Study Phase

PHASE1

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

One Community Health

Sacramento, California, United States, 95811

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

Fort Pierce, Florida, United States, 34982

University of Miami Miller School of Medicine Schiff Center for Liver Disease

Miami, Florida, United States, 33136

Orlando Immunology Center

Orlando, Florida, United States, 32803

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

Be Well Medical Center

Berkley, Michigan, United States, 48072

AXCES Research Group

Santa Fe, New Mexico, United States, 87505

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

Central Texas Clinical Research

Austin, Texas, United States, 78705

The Crofoot Research, INC.

Houston, Texas, United States, 77098

Peter Shalit, M.D.

Seattle, Washington, United States, 98104

Study to Evaluate the Safety and Efficacy of Teropavimab and Zinlirvimab in Combination With Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection