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NCT07719491PHASE1Recruiting

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

Gilead Sciences

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

Key Inclusion Criteria: * Age ≥ 18 years and age ≤ 65 years at screening * On stable antiretroviral (ARV) treatment for ≥ 12 consecutive months prior to screening, throughout the duration of study treatment and follow-up * The following ARV agents are not allowed as part of the current ART regimen: entry inhibitors (maraviroc, enfuvirtide, ibalizumab, or fostemsavir) * Plasma HIV-1 RNA \< 50 copies/mL for ≥ 12 months before and at screening with at least 2 documented HIV-1 RNA \<50 copies/mL within the last 12 months. * Clusters of differentiation 4 (CD4) count ≥ 350 cells/μL * Weight ≥ 50 kg and ≤ 110 kg at screening and Day 1 * Body mass index (BMI) ≥ 18.5 kg/m2 and ≤ 35 kg/m2 at screening and Day 1 Key Exclusion Criteria: * Documented history of pre-ART CD4 nadir \< 100 cells/μL. Unknown pre-ART CD4 nadir is acceptable * Known to have initiated ART within 6 months of HIV infection. Unknown time between infection and ART initiation is acceptable * Females who are pregnant or breastfeeding or who may wish to become pregnant during the study or within 42 days after last study drug administration * Have chronic hepatitis B virus (HBV) as determined by either: 1. Positive HBV surface antigen, regardless of HBV core antibody status, at the Screening visit 2. Positive HBV core antibody and negative HBV surface antibody, regardless of HBV surface antigen status, at the Screening visit * Have active hepatitis C virus (HCV) infection: 1.) Positive anti-HCV antibody and negative HCV polymerase chain reaction (PCR) results are acceptable * Have a history of any of the following: 2.) Significant serious skin disease, such as but not limited to rash, food allergy, eczema, psoriasis, or urticaria as assessed by the investigator 3.) Significant drug sensitivity or drug allergy ('but not limited to anaphylaxis or drug-induced liver injury) as assessed by the investigator 4.) Known hypersensitivity to the study drugs, their metabolites, or to formulation excipients 5.) Previous or current history of bleeding disorder, platelet disorder including unexplained acute or chronic thrombocytopenia 6.) Autoimmune diseases including Type 1 diabetes mellitus 7.) Serious or active medical or psychiatric illness that would interfere with participant treatment, assessment, or compliance with the protocol. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Interventions

DRUG

GS-0415

DRUG

GS-0415 Placebo

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Conditions

HIV -1 Infection

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