GS-0415 for HIV
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Gilead Study Director
Principal Investigator
Gilead Sciences
Are You a Good Fit for This Trial?
This trial is for adults aged 18-65 living with HIV-1 who have had undetectable viral loads and stable antiretroviral treatment for at least a year. Participants must have a healthy immune cell count, weigh between 50–110 kg, and not be taking certain HIV drugs called entry inhibitors.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- GS-0415
Trial Overview
The study is testing different single and multiple doses of a new drug called GS-0415 (given by injection or IV) compared to placebo in people with well-controlled HIV. The main goal is to see how safe the drug is and how it behaves in the body.
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
Participants will receive escalating doses of GS-0415 via SC or IV at five different timepoints up to Date 57.
Participants will receive placebo to match escalating doses of GS-0415 via SC or IV at five different timepoints up to Day 57.
Participants will receive placebo to match the single escalating doses of GS-0415 via SC or IV on Day 1.
Participants will receive single escalating doses of GS-0415 via SC or IV on Day 1.
Participants will receive single escalating doses of GS-0415 via subcutaneous (SC) or intravenously (IV) on Day 1.
Participants will receive placebo to match the single escalating doses of GS-0415 via SC or IV on Day 1.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Gilead Sciences
Lead Sponsor
Daniel O'Day
Gilead Sciences
Chief Executive Officer since 2019
MBA from Columbia University
Dietmar Berger
Gilead Sciences
Chief Medical Officer
MD and PhD from Albert-Ludwigs University School of Medicine
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