Safety and Efficacy Study for a New Antiviral Drug to Treat Genital Herpes Type 2

AiCuris

Status and phase: Completed; Phase 2

Conditions: HSV-2

Treatments: Drug: Placebo; Drug: AIC316

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01047540

AIC316-01-II-01

Details and patient eligibility

About

The aim of the study is to find out whether AIC316 is safe and efficacious for the prevention of reactivation of genital herpes

Enrollment: 156 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
• History of recurrent episodes of genital herpes for at least 12 months
• Seropositive for Herpes Simplex Virus HSV Type 2
• Body Mass Index (BMI) between 18 and 35 kg/m2

Exclusion criteria

• Present episode of genital herpes
• Intake of systemic drug against HSV or any topical application against HSV within 7 days before randomization for the trial
• Intake of systemic corticosteroids, other immunomodulating agents or any investigational agent within 3 months before randomization for the trial
• Positive results in any of the virology tests for human immunodeficiency virus antibody (HIV-Ab), hepatitis C antibody (HCV-Ab), hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBc-Ab)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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156 participants in 5 patient groups, including a placebo group

Dose regimen 1

Experimental group

Treatment:

Drug: AIC316

Drug: AIC316

Drug: AIC316

Drug: AIC316

Dose regimen 2

Experimental group

Treatment:

Drug: AIC316

Drug: AIC316

Drug: AIC316

Drug: AIC316

Dose regimen 3

Experimental group

Treatment:

Drug: AIC316

Drug: AIC316

Drug: AIC316

Drug: AIC316

Dose regimen 4

Experimental group

Treatment:

Drug: AIC316

Drug: AIC316

Drug: AIC316

Drug: AIC316

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo