Study of GS-0415 and How It Works in People With HIV (NCT07719491) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Study of GS-0415 and How It Works in People With HIV
112 participantsStarted 2026-07
Plain-language summary
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 can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Positive HBV surface antigen, regardless of HBV core antibody status, at the Screening visit
. Positive HBV core antibody and negative HBV surface antibody, regardless of HBV surface antigen status, at the Screening visit
.) Positive anti-HCV antibody and negative HCV polymerase chain reaction (PCR) results are acceptable
.) Significant serious skin disease, such as but not limited to rash, food allergy, eczema, psoriasis, or urticaria
.) Significant drug sensitivity or drug allergy ('but not limited to anaphylaxis or drug-induced liver injury)
.) Known hypersensitivity to the study drugs, their metabolites, or to formulation excipients
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs)
Timeframe: First dose date up to 99 days
2
Percentage of Participants Experiencing Clinical Laboratory Abnormalities
Timeframe: First dose date up to 99 days
3
Serum Pharmacokinetic (PK) Parameter (After Single Ascending Dose (SAD)): AUCinf of GS-0145
Timeframe: Up to 43 days
4
Serum PK Parameters (SAD): Cmax of GS-0145
Timeframe: Up to 43 days
5
Serum PK Parameters Multiple Ascending Dose (MAD): Dose 1 and Dose 5: AUCtau of GS-0145
Timeframe: Up to 99 days
6
Serum PK Parameters MAD: Dose 1 and Dose 5: Cmax of GS-0145