RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: Gilead Sciences • ClinicalTrials.gov ID: NCT07719491

Registry updated: 2026-09-23

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Description

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.

Interventions

GS-0415 (Drug)
Administered SC or IV
GS-0415 Placebo (Drug)
Administered SC or IV

Eligibility criteria

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.

Conditions

HIV -1 Infection

Locations

Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
Georgetown University Medical Center — Washington D.C., District of Columbia, United States
Floridian Clinical Research, LLC — Miami Lakes, Florida, United States
Triple O Research Institute, P.A. — West Palm Beach, Florida, United States
Emory University Hospital Midtown Infectious Disease Clinic — Atlanta, Georgia, United States
Centricity Research CPU - Georgia — Columbus, Georgia, United States
Indiana CTSI Clinical Research Center — Indianapolis, Indiana, United States
Brigham and Women's Hospital — Boston, Massachusetts, United States
Boston Medical Center — Boston, Massachusetts, 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
Duke Early Phase Clinical Research Unit — Durham, North Carolina, United States
Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
University of Cincinnati College of Medicine — Cincinnati, Ohio, United States
The Ohio State University Medical Center Infectious Diseases Clinic — Columbus, Ohio, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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