GUD Clinical and Virologic Response to Acyclovir in HIV Negative African Women

Not Applicable

Completed

• Conditions: Genital Herpes
• Interventions: Drug: matching placebo; Drug: acyclovir

• Registration Number: NCT00808405
• Lead Sponsor: University of Washington

Brief Summary

To examine the time to healing of genital lesion and duration of herpes simplex virus (HSV) shedding from genetic ulcer disease (GUD) among 90 HIV-negative African women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative randomized in a 2:1 ratio to receive episodic acyclovir 400mg orally three times daily or matching placebo three times daily for 5 days and who are followed for a total of 13 days.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-25
• Study First Submitted QC: 2008-12-12
• Study First Posted: 2008-12-15
• Study Start: 2009-01
• Primary Completion: 2009-12
• Study Completion: 2010-07
• Disposition First Submitted: 2011-03-31
• Disposition First Submitted QC: 2011-03-31
• Disposition First Posted: 2011-04-07
• Results First Submitted: 2012-04-20
• Results First Submitted QC: 2012-04-20
• Results First Posted: 2012-05-18
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-15
• Last Update Posted: 2013-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 88

Inclusion Criteria

• HIV negative as determined by concordant rapid testing
• HSV-2 seropositive (Focus HerpeSelect >3.4)
• At least one prior occurrence of GUD
• 18-50 years of age

Exclusion Criteria

• Current use, or use w/in past 7 days of acyclovir, valacyclovir, or famciclovir
• Prior hypersensitivity &/or allergic reaction to acyclovir
• Use of probenicid
• Current use, or use within past 28 days, of an investigational agent
• Currently pregnant or nursing
• Currently plan to become pregnant during next 3 months
• Any condition that will interfere with successful completion of study procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	matching placebo	-
acyclovir	acyclovir	-

Primary Outcome Measures

Name	Time	Method
Time to Healing of Genital Lesions	Days 1-5, 7, 9, 11, 13	To examine time to healing of genital lesions among women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative, and who are randomized to 400mg acyclovir or matching placebo

Secondary Outcome Measures

Name	Time	Method
Time to First Negative Herpes Simplex Virus (HSV) DNA PCR	Days 1-5, 7, 9, 11, 13	To examine the time to first negative HSV DNA PCR among women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative, and who are randomized to 400mg acyclovir or matching placebo

Trial Locations

Locations (2)

Reproductive Health and HIV Research Unit (RHRU); 🇿🇦 Johannesburg, South Africa

Center for Infectious Disease Research of Zambia (CIDRZ); 🇿🇲 Lusaka, Zambia