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

AiCuris

Status and phase: Terminated; Phase 2

Conditions: Genital Herpes

Treatments: Drug: Valacyclovir; Drug: AIC316

Study type: Interventional

Funder types: Industry

Identifiers

NCT01658826

AIC316-01-II-02

Details and patient eligibility

About

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.

Full description

Enrolled patients with Mucocutaneous genital HSV, will be randomized to receive either AIC326 or Valacyclovir first and then will be crossed over to receive the opposite Intervention. The study will consist of two treatment periods of 28 days separated by a washout period of 28 days.

Enrollment: 91 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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91 participants in 2 patient groups

AIC316, Then Valacyclovir

Experimental group

Description:

Participants first received AIC316 100 mg once daily for 28 days. After a washout period of 28 days, they then received Valacyclovir 500 mg once daily for 28 days.

Treatment:

Drug: Valacyclovir

Drug: AIC316

Valacyclovir, Then AIC316

Active Comparator group

Description:

Participants first received Valacyclovir 500 mg once daily for 28 days. After a washout period of 28 days, they then received AIC316 100 mg once daily for 28 days.

Treatment:

Drug: Valacyclovir

Drug: AIC316