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.

Condition	Treatment or Intervention
Herpes Simplex HIV Infections	Drug: Crofelemer  Drug: Acyclovir

Further Study Details: 

Expected Total Enrollment:  400

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.

Alabama
      Sorra Research Ctr Inc / Med Forum, Birmingham,  Alabama,  35203,  United States
Arizona
      Arizona Clinical Research Ctr Inc, Tucson,  Arizona,  85712,  United States
      Hill Top Research Ltd, Scottsdale,  Arizona,  85251,  United States
California
      Olive View Med Ctr, Sylmar,  California,  91342,  United States
      ViRx Inc, Palm Springs,  California,  92262,  United States
      Dermatology SVC - VAMC, Long Beach,  California,  90822,  United States
      Conant Med Ctr, San Francisco,  California,  94117,  United States
      King - Drew Med Ctr / Dept of Dermatology, Los Angeles,  California,  90059,  United States
      ViRx Inc, San Francisco,  California,  94109,  United States
      Summit Med Ctr / Adult Immunology Clinic, Oakland,  California,  94609,  United States
District of Columbia
      Novum Inc, Washington,  District of Columbia,  20037,  United States
Florida
      Infectious Disease Research Institute Inc, Tampa,  Florida,  33614,  United States
      Gary Richmond MD, Fort Lauderdale,  Florida,  33316,  United States
      IDC Research Initiative, Altamonte Springs,  Florida,  32701,  United States
      Dr Robert Schwartz, Fort Myers,  Florida,  33901,  United States
      Treasure Coast Infectious Disease Consultants, Vero Beach,  Florida,  32960,  United States
Illinois
      Veterans Affairs Med Ctr of North Chicago, Chicago,  Illinois,  60064,  United States
Maryland
      Johns Hopkins Univ / Division of Infectious Disease, Baltimore,  Maryland,  21205,  United States
      Saint Agnes Healthcare / Dept of Surgery, Baltimore,  Maryland,  21229,  United States
Massachusetts
      Massachusetts Gen Hosp - Warren 505, Boston,  Massachusetts,  02114,  United States
Minnesota
      Medicine / Infectious Diseases, Minneapolis,  Minnesota,  55455,  United States
New York
      Columbia Presbyterian Med Ctr, New York,  New York,  10032,  United States
      Mount Sinai Med Ctr, New York,  New York,  10029,  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
Pennsylvania
      Paddington Testing Co Inc, Philadelphia,  Pennsylvania,  19103,  United States
Texas
      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
      Austin Infectious Disease Consultants, Austin,  Texas,  78705,  United States
Virginia
      Dr Robert Holman, Arlington,  Virginia,  22205,  United States
Washington
      Novum Inc, Seattle,  Washington,  98122,  United States
      Univ of Washington Virology Research Clinic, Seattle,  Washington,  98122,  United States
Puerto Rico
      Hosp Regional de Ponce - Area Vieja, Ponce,  00731,  Puerto Rico
      San Juan AIDS Program, Santurce,  00908,  Puerto Rico

Study ID Numbers:  270A; 96-867-DE
Record last reviewed:  February 1998
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002186
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08