TerminatedPhase 2

Safety and Efficacy Comparator Trial of a New Drug Against Genital Herpes

United States91 participantsStarted 2012-10

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Within-subject Genital HSV Mucocutaneous Shedding Rate

Timeframe: 28 days

Overall Shedding Rate

Timeframe: 28 days

Trial details

NCT IDNCT01658826

SponsorAiCuris Anti-infective Cures AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-05

Results submitted2022-01-06

View on ClinicalTrials.gov More Genital Herpes trials