Study of GS-0415 and How It Works in People With HIV
Start Date
7/22/2026
Completion Date
8/1/2029
Summary
The goals of this clinical study are to learn more about the study drug GS-0415, safety, tolerability, and pharmacokinetics (PK) of single ascending doses (SAD) and multiple ascending doses (MAD) of subcutaneous (SC) and intravenous (IV) GS-0415 in people with HIV-1 (PWH) on antiretroviral treatment. The primary objectives of this study are to evaluate the safety and tolerability of escalating, single and multiple subcutaneous (SC) and intravenous (IV) doses of GS-0415, administered in PWH who are virologically suppressed on antiretroviral therapy (ART) and to evaluate the pharmacokinetics (PK) of GS-0415.
Eligibility Criteria
Age Range: 18 years to 65 years
Interventions
GS-0415
GS-0415 Placebo
Conditions
Locations
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027
United States
Georgetown University Medical Center
Washington D.C., District of Columbia 20007
United States
Floridian Clinical Research, LLC
Miami Lakes, Florida 33016
United States
Triple O Research Institute, P.A.
West Palm Beach, Florida 33407
United States
Emory University Hospital Midtown Infectious Disease Clinic
Atlanta, Georgia 30308
United States
Centricity Research CPU - Georgia
Columbus, Georgia 31904
United States
Indiana CTSI Clinical Research Center
Indianapolis, Indiana 46202
United States
Brigham and Women's Hospital
Boston, Massachusetts 02115
United States
Boston Medical Center
Boston, Massachusetts 02118
United States
PPD Development, LP
Las Vegas, Nevada 89113
United States
St. Michaels Medical Center
Newark, New Jersey 07102
United States
Jacobi Medical Center
The Bronx, New York 10461
United States
Duke Early Phase Clinical Research Unit
Durham, North Carolina 27710
United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
United States
University of Cincinnati College of Medicine
Cincinnati, Ohio 45267
United States
The Ohio State University Medical Center Infectious Diseases Clinic
Columbus, Ohio 43210
United States