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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Gilead Sciences
Study ID
NCT07719491
Phase
PHASE1
Status
Recruiting
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Conditions

  • HIV -1 Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • GS-0415 — DRUG
    Administered SC or IV
  • GS-0415 Placebo — DRUG
    Administered SC or IV

Study Details

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.

Key Dates

First listed
Jul 22, 2026
Start date
Jul 22, 2026
Status verified
Aug 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
112 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A Single Ascending Dose (SAD): GS-0415
    Participants will receive single escalating doses of GS-0415 via subcutaneous (SC) or intravenously (IV) on Day 1.
  • Experimental: Group A SAD: Placebo
    Participants will receive placebo to match the single escalating doses of GS-0415 via SC or IV on Day 1.
  • Experimental: Group B SAD: GS-0415
    Participants will receive single escalating doses of GS-0415 via SC or IV on Day 1.
  • Experimental: Group B SAD: Placebo
    Participants will receive placebo to match the single escalating doses of GS-0415 via SC or IV on Day 1.
  • Experimental: Group C Multiple Ascending Dose (MAD): GS-0415
    Participants will receive escalating doses of GS-0415 via SC or IV at five different timepoints up to Date 57.
  • Experimental: Group C MAD: Placebo
    Participants will receive placebo to match escalating doses of GS-0415 via SC or IV at five different timepoints up to Day 57.

Primary Outcome Measure

Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) [ Time Frame: First dose date up to 99 days ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Kaiser Permanente Los Angeles Medical CenterLos AngelesCalifornia90027-
Georgetown University Medical CenterWashington D.C.District of Columbia20007-
Triple O Research Institute, P.A.West Palm BeachFlorida33407-
PPD Development, LPLas VegasNevada89113-
St. Michaels Medical CenterNewarkNew Jersey07102-
Jacobi Medical CenterThe BronxNew York10461-
The Ohio State University Medical Center Infectious Diseases ClinicColumbusOhio43210-

Find similar trials in Los Angeles, CA

By research site
Kaiser Permanente Los Angeles Medical Center· Los Angeles, CAGeorgetown University Medical Center· Washington D.C., DCTriple O Research Institute, P.A.· West Palm Beach, FLPPD Development, LP· Las Vegas, NVSt. Michaels Medical Center· Newark, NJJacobi Medical Center· The Bronx, NY

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