Double-Blind Placebo-Controlled Study Comparing the Combination of 15% SP-303 Gel With Acyclovir Versus Acyclovir Alone for the Treatment of Recurrent Herpes Simplex Virus (HSV) Infections in Subjects With Acquired Immunodeficiency Syndrome (AIDS)

Inclusion Criteria Patients must have: AIDS, according to the CDC criteria. Documented recurrent (at least 1 prior episode) perineal (genital, perianal and neighboring areas) mucocutaneous herpes simplex virus (HSV) types 1 or 2 infection in the active phase. Duration of current episode of recurrent HSV lesions of 3 days or less. Ability to read and write, must be intellectually competent, and able to understand the purposes and risks of the study. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: Active internal anal or rectal herpes. Inability to comply with protocol. Impaired renal function. Patients with the following prior conditions are excluded: Prior episode of recurrent genital herpes infection with documented clinical failure of acyclovir as a treatment regimen. Uncompensated hepatic, cardiac, or renal failure within 1 month of the study. History of hypersensitivity to acyclovir. Previous enrollment in this study. 1. Treatment with another medication (topical, oral, or intravenous) with known anti-HSV activity within the past 5 days. Systemic immunomodulatory therapy within 30 days prior to study. Previous treatment with SP-303. Required: Unchanged antiretroviral therapy for the 2 weeks prior to study.