Study of GS-0415 and How It Works in People With HIV
Public ClinicalTrials.gov record NCT07719491. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT07719491
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 112 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 22, 2026 (Actual)
- Primary completion
- Aug 2029 (Estimated)
- Completion
- Aug 2029 (Estimated)
- Last update posted
- Sep 23, 2026
2026 – 2029
United States locations
- U.S. sites
- 16
- U.S. states
- 11
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | 90027 | Recruiting |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | Recruiting |
| Floridian Clinical Research, LLC | Miami Lakes | Florida | 33016 | Recruiting |
| Triple O Research Institute, P.A. | West Palm Beach | Florida | 33407 | Recruiting |
| Emory University Hospital Midtown Infectious Disease Clinic | Atlanta | Georgia | 30308 | Recruiting |
| Centricity Research CPU - Georgia | Columbus | Georgia | 31904 | Recruiting |
| Indiana CTSI Clinical Research Center | Indianapolis | Indiana | 46202 | Recruiting |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | Recruiting |
| Boston Medical Center | Boston | Massachusetts | 02118 | Recruiting |
| PPD Development, LP | Las Vegas | Nevada | 89113 | Recruiting |
| St. Michaels Medical Center | Newark | New Jersey | 07102 | Not yet recruiting |
| Jacobi Medical Center | The Bronx | New York | 10461 | Recruiting |
| Duke Early Phase Clinical Research Unit | Durham | North Carolina | 27710 | Recruiting |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | Recruiting |
| University of Cincinnati College of Medicine | Cincinnati | Ohio | 45267 | Recruiting |
| The Ohio State University Medical Center Infectious Diseases Clinic | Columbus | Ohio | 43210 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07719491, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 23, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07719491 live on ClinicalTrials.gov.