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Study of GS-0415 and How It Works in People With HIV
Sponsor: Gilead Sciences
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.
Official title: A First-in-Human Phase 1b, Single-Blind, Placebo-controlled Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Evaluate Safety and Pharmacokinetics of GS-0415 in People With HIV-1 Who Are Virologically Suppressed on Antiretroviral Treatment
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
112
Start Date
2026-07-22
Completion Date
2029-08
Last Updated
2026-09-01
Healthy Volunteers
No
Conditions
Interventions
GS-0415
Administered SC or IV
GS-0415 Placebo
Administered SC or IV
Locations (7)
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Triple O Research Institute, P.A.
West Palm Beach, Florida, United States
PPD Development, LP
Las Vegas, Nevada, United States
St. Michaels Medical Center
Newark, New Jersey, United States
Jacobi Medical Center
The Bronx, New York, United States
The Ohio State University Medical Center Infectious Diseases Clinic
Columbus, Ohio, United States