NCT00002186

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (planned)
• Sponsor: Shaman Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Herpes Simplex
• HIV Infections

Interventions

Type	Name	Description
DRUG	Crofelemer
DRUG	Acyclovir

Timeline

• First posted: 2001-08-31
• Last updated: 2005-06-24

Locations

34 sites across 2 countries: United States, Puerto Rico