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Phase 2Not yet recruiting

Study to Compare GS-1179 Versus Valacyclovir in HSV-2 Seropositive Participants With Recurrent Genital Herpes

A Phase 2b, Randomized, Double-Blind, Active-Control, Parallel-Group Study to Evaluate the Safety and Efficacy of GS-1179 Versus Valacyclovir in HSV-2 Seropositive Participants With Recurrent Genital Herpes

Sponsor
Gilead Sciences (Industry)
Enrollment
300 planned
Conditions
HSV-2 Infection
Interventions
GS-1179; GS-1179 PTM; Valacyclovir; Valacyclovir PTM
Ages
adults, older adults
Registry
NCT07912996

Full record on ClinicalTrials.gov

From the registry

The goal of this clinical study is to compare the study drug GS-1179, versus valacyclovir (VACV) in herpes simplex virus type 2 (HSV-2) seropositive participants with recurrent genital herpes. The primary objective of this study are to evaluate the safety and tolerability of GS-1179 versus VACV and to evaluate the antiviral effect of GS-1179 versus VACV.

Primary outcomes

  • Percentage of Participants Experiencing Adverse Events (AEs)
  • Percentage of Participants Experiencing Premature Study-Dug Discontinuation due to AEs
  • Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
  • Herpes Simplex Virus Type 2 (HSV-2) Shedding Rate During the Swabbing Period

History

  1. Primary completion expected

  2. Expected to start

  3. Registered