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RECRUITING
NCT07719491
PHASE1

Study of GS-0415 and How It Works in People With HIV

Sponsor: Gilead Sciences

View on ClinicalTrials.gov

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

Interventions

DRUG

GS-0415

Administered SC or IV

DRUG

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