Study of GS-0415 and How It Works in People With HIV
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
- HIV -1 Infection
At a glance
- Phase
- Phase 1
- Study type
- Interventional
- Sponsor
- Gilead Sciences
- Enrolment target
- 112
- Started
- 22 July 2026
- Main results due
- August 2029
- Study sites
- 16
- Registry updated
- 23 September 2026
Can you take part?
- Ages 18 years to 65 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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.What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(16)
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Recruiting
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Recruiting
Floridian Clinical Research, LLC
Miami Lakes, Florida, United States
Recruiting
Triple O Research Institute, P.A.
West Palm Beach, Florida, United States
Recruiting
Emory University Hospital Midtown Infectious Disease Clinic
Atlanta, Georgia, United States
Recruiting
Centricity Research CPU - Georgia
Columbus, Georgia, United States
Recruiting
Indiana CTSI Clinical Research Center
Indianapolis, Indiana, United States
Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, United States
Recruiting
Boston Medical Center
Boston, Massachusetts, United States
Recruiting
PPD Development, LP
Las Vegas, Nevada, United States
Recruiting
St. Michaels Medical Center
Newark, New Jersey, United States
Not yet recruiting
Jacobi Medical Center
The Bronx, New York, United States
Recruiting
Duke Early Phase Clinical Research Unit
Durham, North Carolina, United States
Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Recruiting
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States
Recruiting
The Ohio State University Medical Center Infectious Diseases Clinic
Columbus, Ohio, United States
Recruiting
Showing 16 of 16 sites. 15 of the 16 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07719491. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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