Gilead's GS-0415 recruiting in Phase 1 HIV trial testing SC/IV dosing

Gilead's registry update this week centers on a single trial record for its investigational drug GS-0415.

• Gilead Sciences is recruiting for a first-in-human Phase 1b, single-blind, placebo-controlled study (NCT07719491) evaluating single ascending and multiple ascending doses of GS-0415, given subcutaneously or intravenously, in people with HIV-1 who are virologically suppressed on antiretroviral treatment.¹ The trial's phase field is listed as "phase1" in the registry, though the study title refers to it as Phase 1b. The record shows a start date and first-posted date both of 2026-07-22, so the recruiting status was set at that time rather than newly this week.
• The study is randomized with a parallel intervention model and an estimated enrollment of 112 participants.¹
• Its primary objectives are to evaluate the safety and tolerability of escalating single and multiple SC and IV doses of GS-0415 in this population, along with its pharmacokinetics.¹
• Secondary outcomes include tracking treatment-emergent anti-GS-0415 antibodies and virological rebound, defined as HIV-1 RNA at or above 50 copies/mL, through up to 99 days.¹