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)
2 other identifiers
interventional
400
2 countries
34
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
February 1, 1998
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Sorra Research Ctr Inc / Med Forum
Birmingham, Alabama, 35203, United States
Hill Top Research Ltd
Scottsdale, Arizona, 85251, United States
Arizona Clinical Research Ctr Inc
Tucson, Arizona, 85712, United States
Dermatology SVC - VAMC
Long Beach, California, 90822, United States
King - Drew Med Ctr / Dept of Dermatology
Los Angeles, California, 90059, United States
Summit Med Ctr / Adult Immunology Clinic
Oakland, California, 94609, United States
ViRx Inc
Palm Springs, California, 92262, United States
ViRx Inc
San Francisco, California, 94109, United States
Conant Med Ctr
San Francisco, California, 94117, United States
Olive View Med Ctr
Sylmar, California, 91342, United States
Novum Inc
Washington D.C., District of Columbia, 20037, United States
IDC Research Initiative
Altamonte Springs, Florida, 32701, United States
Gary Richmond MD
Fort Lauderdale, Florida, 33316, United States
Dr Robert Schwartz
Fort Myers, Florida, 33901, United States
Infectious Disease Research Institute Inc
Tampa, Florida, 33614, United States
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, 32960, United States
Veterans Affairs Med Ctr of North Chicago
Chicago, Illinois, 60064, United States
Johns Hopkins Univ / Division of Infectious Disease
Baltimore, Maryland, 21205, United States
Saint Agnes Healthcare / Dept of Surgery
Baltimore, Maryland, 21229, United States
Massachusetts Gen Hosp - Warren 505
Boston, Massachusetts, 02114, United States
Medicine / Infectious Diseases
Minneapolis, Minnesota, 55455, United States
AIDS Ctr / Saint Vincents Hosp and Med Ctr
New York, New York, 10011, United States
New York Univ Med Ctr
New York, New York, 10016, United States
Mount Sinai Med Ctr
New York, New York, 10029, United States
Columbia Presbyterian Med Ctr
New York, New York, 10032, United States
Paddington Testing Co Inc
Philadelphia, Pennsylvania, 19103, United States
Austin Infectious Disease Consultants
Austin, Texas, 78705, United States
N Texas Ctr for AIDS & Clin Rsch
Dallas, Texas, 75219, United States
Division of Infectious Diseases / Univ of Texas - Houston
Houston, Texas, 77030, United States
Dr Robert Holman
Arlington, Virginia, 22205, United States
Novum Inc
Seattle, Washington, 98122, United States
Univ of Washington Virology Research Clinic
Seattle, Washington, 98122, United States
Hosp Regional de Ponce - Area Vieja
Ponce, 00731, Puerto Rico
San Juan AIDS Program
Santurce, 00908, Puerto Rico