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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01658826
Other study ID # AIC316-01-II-02
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date October 2012
Est. completion date July 2013

Study information

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

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 91
Est. completion date July 2013
Est. primary completion date May 2013
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 - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
AIC316
100 mg oral administration
Valacyclovir
500 mg 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, IU Infectious Diseases Research Indianapolis Indiana
United States Westover Heights Clinic Portland Oregon
United States University of Washington, Virology Research Clinic Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
AiCuris Anti-infective Cures AG Medpace, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Within-subject Genital HSV Mucocutaneous Shedding Rate Subjects were assessed for within-subject genital HSV mucocutaneous shedding rate, as calculated by the number of HSV-positive swabs per subject relative to the total number of swabs collected per subject. The swab test detects the presence of herpes virus DNA. A swab was regarded as positive for HSV-DNA if at least 3 HSV genome copies were detected by quantitative PCR per reaction (equaling 150 copies per mL of swab collection medium). When multiple swabs were available from the same time point (e.g., genital and lesional swab), the swab with the highest copy number was retained for computation of the shedding rate. 28 days
Primary Overall Shedding Rate Subjects were assessed for overall shedding rate as the total number of HSV-positive swabs per treatment group divided by the number of swabs collected per treatment group. 28 days
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