Acyclovir Therapy for Genital Herpes Ulcers in HIV Negative African Women

This is a two-part study designed to measure the Area Under the Curve (AUC) from a single dose of acyclovir 400mg in 60 African HIV-negative heterosexual women who have a history of genital ulcer disease (GUD), are HSV-2 seropositive and HIV-1 seronegative. The study will also examine the time to healing of genital lesion and duration of HSV shedding from GUD among 90 HIV negative African women who have a history of GUD and are Herpes Simplex Virus (HSV)-2 seropositive and HIV-1 seronegative randomized in a 2:1 ratio to receive episodic acyclovir or matching placebo.

Inclusion criteria

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

Exclusion criteria

• Current use, or use within the past 7 days, of acyclovir, valacyclovir, or famciclovir
• Prior hypersensitivity and/or allergic reaction to acyclovir
• Use of probenecid, which prolongs renal excretion of acyclovir
• Current use, or use within the past 28 days, of an investigational agent
• Currently pregnant or nursing
• Currently plan to become pregnant during the next 3 months
• Currently consume, on average, more than 7 drinks of alcohol per week (for Part I)
• Current use of more than 20 cigarettes daily (for Part I)
• Any condition that in the opinion of the investigator will interfere with successful completion of all study procedures.