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

StatusRecruiting
PhasePhase 1
Started2026-07-22
View on ClinicalTrials.gov ↗

Amendment history

2026-08-28
Study Status, Eligibility, Contacts/Locations, References v1
Trial sites expanded: 7 → 16 locations
Recruitment opened
Trial sites expanded: 0 → 7 locations
Start dateestimated 2026-07→confirmed 2026-07-22
Eligibility criteria+91 characters
[...] 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 copie [...] mited 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 metabo [...]
2026-07-17
Original filing
Gilead Sciences
107 trials monitored
See 8 trials at risk
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.
Trial Details
NCT Number NCT07719491
Lead Sponsor Gilead Sciences
Conditions HIV -1 Infection
Enrollment 112 participants
Start Date 2026-07-22
Primary Completion 2029-08 (estimated)
Study Completion 2029-08 (estimated)
Updated on ClinicalTrials.gov 2026-09-23