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)

Launched by SHAMAN PHARMACEUTICALS · Aug 30, 2001

Keywords

ClinConnect Summary

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...

Gender

ALL

Eligibility criteria

• • 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.