Acyclovir Therapy for Genital Herpes Ulcers 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

This is a prospective study to evaluate the pharmacokinetics, clinical and virologic response to acyclovir episodic 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.