To evaluate the safety of topically applied SP-303 gel and to compare the efficacy of SP-303 gel in combination with acyclovir, relative to acyclovir alone, for the treatment of recurrent Herpes Simplex Virus (HSV) 1 and 2 infections, affecting the genital, perianal and neighboring areas, in patients with AIDS.

This trial is a double-blind, multicenter, placebo-controlled clinical trial. Participants are randomized to topical 15% SP-303 gel and oral acyclovir or to matching topical placebo gel and oral acyclovir. At presentation, patients are stratified by total lesion area within each treatment group. SP-303 or matching placebo is topically applied three times a day until all lesions are reepithelialized or for 14 days, whichever occurs earlier. Acyclovir is administered by mouth each day, three times a day, until all lesions are reepithelialized or for 14 days, whichever occurs earlier. Patients are evaluated for lesion healing and adverse events 3 times per week during the treatment period. The primary efficacy endpoint will be complete lesion healing and the primary analysis will be time to complete healing.

• Herpes Simplex
• HIV Infections

• Drug: Crofelemer
• Drug: Acyclovir

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.