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

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Washington
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); National Institutes of Health (NIH)
• Treatments: Acyclovir

Criteria

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