A Double-blind, Double Dummy, Randomized Crossover Trial to Compare the Effect of "AIC316 (Pritelivir)" 100 mg Once Daily Versus Valacyclovir 500 mg Once Daily on Genital HSV Shedding in HSV-2 Seropositive Adults.

AIC316-01-II-02

The aim of the study is to evaluate the safety and efficacy of "AIC316 (pritelivir)" 100 mg once daily compared to valacyclovir 500 mg once daily for the prevention of HSV-2 genital shedding.

2012-10-01

2013-05-01

2013-07-01

Terminated

Early phase I

91

Inclusion Criteria: * Adult, immunocompetent men and women in good health of any ethnic group * Seropositive for Herpes Simplex Virus Type 2 (HSV-2) * History of recurrent episodes (\>=4 to \<=9) of genital herpes for at least 12 months and willingness to obtain 4 swabs per day. Exclusion Criteria: * Present episode of genital herpes at time of randomization * Clinically relevant acute or chronic infections (excluding HSV-2) * Known intolerance to valacyclovir, acyclovir, or any component of the formulation * Documented HSV resistance to acyclovir, valacyclovir, famciclovir or penciclovir

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 91, 'type': 'ACTUAL'}}

2023-04-21