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

HSV-2 Clinical Trial

Official title:

A Double-blind Randomized Placebo Controlled Dose-finding Trial to Investigate Different Doses of a New Antiviral Drug in Subjects With Genital HSV Type 2 Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01047540
• Other study ID #: AIC316-01-II-01
• Status: Completed
• Phase: Phase 2
• Start date: March 2010
• Est. completion date: March 2011

Study information

• Verified date: April 2023
• Source: AiCuris Anti-infective Cures AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: March 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• HSV-2

Intervention

Drug:
• AIC316
Oral administration
• AIC316
Oral administration
• AIC316
Oral administration
• AIC316
Oral administration
• Placebo
Oral administration

Locations

Country	Name	City	State
United States	University of Texas Health Science Centre, Center for Clincial Studies	Houston	Texas
United States	Indiana University School of Medicine, Office for Research	Indianapolis	Indiana
United States	Cetero Research Miami Gardens	Miami	Florida
United States	Westover Heights Clinic	Portland	Oregon
United States	University of Utah	Salt Lake City	Utah
United States	University of Washington, Virology Research Clinic	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
AiCuris Anti-infective Cures AG	FHI 360

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of 4 Different Doses of AIC316 and Matching Placebo With Respect to the Suppression of Herpes Simplex Virus Replication (Shedding Rate)	Subjects were assessed for shedding rate as the percentage of number of swab days with at least one swab positive for HSV DNA relative to the total number of days with analyzable swabs. Measurement was based on presence of HSV DNA measured on the material collected from swabs taken at the visits by the investigator and daily swabbing of the anogenital region by the patient during the treatment and post-treatment period.	28 days