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)
- Conditions
- Herpes SimplexHIV Infections
- Registration Number
- NCT00002186
- Lead Sponsor
- Shaman Pharmaceuticals
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (32)
Johns Hopkins Univ / Division of Infectious Disease
🇺🇸Baltimore, Maryland, United States
Division of Infectious Diseases / Univ of Texas - Houston
🇺🇸Houston, Texas, United States
Gary Richmond MD
🇺🇸Fort Lauderdale, Florida, United States
Saint Agnes Healthcare / Dept of Surgery
🇺🇸Baltimore, Maryland, United States
Paddington Testing Co Inc
🇺🇸Philadelphia, Pennsylvania, United States
Univ of Washington Virology Research Clinic
🇺🇸Seattle, Washington, United States
Olive View Med Ctr
🇺🇸Sylmar, California, United States
Conant Med Ctr
🇺🇸San Francisco, California, United States
Hosp Regional de Ponce - Area Vieja
🇵🇷Ponce, Puerto Rico
Infectious Disease Research Institute Inc
🇺🇸Tampa, Florida, United States
AIDS Ctr / Saint Vincents Hosp and Med Ctr
🇺🇸New York, New York, United States
Novum Inc
🇺🇸Seattle, Washington, United States
IDC Research Initiative
🇺🇸Altamonte Springs, Florida, United States
Columbia Presbyterian Med Ctr
🇺🇸New York, New York, United States
Dr Robert Schwartz
🇺🇸Fort Myers, Florida, United States
Treasure Coast Infectious Disease Consultants
🇺🇸Vero Beach, Florida, United States
ViRx Inc
🇺🇸San Francisco, California, United States
Medicine / Infectious Diseases
🇺🇸Minneapolis, Minnesota, United States
Veterans Affairs Med Ctr of North Chicago
🇺🇸Chicago, Illinois, United States
Massachusetts Gen Hosp - Warren 505
🇺🇸Boston, Massachusetts, United States
N Texas Ctr for AIDS & Clin Rsch
🇺🇸Dallas, Texas, United States
Mount Sinai Med Ctr
🇺🇸New York, New York, United States
Austin Infectious Disease Consultants
🇺🇸Austin, Texas, United States
New York Univ Med Ctr
🇺🇸New York, New York, United States
Dr Robert Holman
🇺🇸Arlington, Virginia, United States
Sorra Research Ctr Inc / Med Forum
🇺🇸Birmingham, Alabama, United States
Arizona Clinical Research Ctr Inc
🇺🇸Tucson, Arizona, United States
Dermatology SVC - VAMC
🇺🇸Long Beach, California, United States
Summit Med Ctr / Adult Immunology Clinic
🇺🇸Oakland, California, United States
King - Drew Med Ctr / Dept of Dermatology
🇺🇸Los Angeles, California, United States
Hill Top Research Ltd
🇺🇸Scottsdale, Arizona, United States
San Juan AIDS Program
🇵🇷Santurce, Puerto Rico