Tests GS-0415 safety and dosing in people with HIV
Tests the drug GS-0415 in adults with HIV already controlled by treatment.
Plain-language title generated from the registry record
Registry title: Study of GS-0415 and How It Works in People With HIV
Key facts
- Where
- Atlanta, Boston, Cincinnati, Columbus, Durham, Indianapolis, Las Vegas, Los Angeles, Miami Lakes, Newark, The Bronx, Washington D.C., West Palm Beach, and Winston-Salem, United StatesSee the 16 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07719491, who can take part
Where in United States
- Emory University Hospital Midtown Infectious Disease ClinicAtlanta, United StatesTaking people
- Boston Medical CenterBoston, United StatesTaking people
- Brigham and Women's HospitalBoston, United StatesTaking people
- University of Cincinnati College of MedicineCincinnati, United StatesTaking people
- Centricity Research CPU - GeorgiaColumbus, United StatesTaking people
- The Ohio State University Medical Center Infectious Diseases ClinicColumbus, United StatesTaking people
- Duke Early Phase Clinical Research UnitDurham, United StatesTaking people
- Indiana CTSI Clinical Research CenterIndianapolis, United StatesTaking people
- PPD Development, LPLas Vegas, United StatesTaking people
- Kaiser Permanente Los Angeles Medical CenterLos Angeles, United StatesTaking people
- Floridian Clinical Research, LLCMiami Lakes, United StatesTaking people
- St. Michaels Medical CenterNewark, United StatesNot yet recruiting
- Jacobi Medical CenterThe Bronx, United StatesTaking people
- Georgetown University Medical CenterWashington D.C., United StatesTaking people
- Triple O Research Institute, P.A.West Palm Beach, United StatesTaking people
- Wake Forest University Health SciencesWinston-Salem, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Gilead Sciences
- Trial code
- NCT07719491
- Record updated
- 23 September 2026
- Original 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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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; 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; Have chronic hepatitis B virus (HBV) as determined by either:; Positive HBV surface antigen, regardless of HBV core antibody status, at the Screening visit; 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.