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NCT07719491From ClinicalTrials.govRecruiting

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