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

Prospective Study of Pharmacokinetics, Clinical and Virologic Response to Acyclovir Episodic Therapy for Genital Herpes Ulcers in HIV Negative African Women

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.

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