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)

June 23, 2005 updated by: Shaman Pharmaceuticals
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Ponce, Puerto Rico, 00731
        • Hosp Regional de Ponce - Area Vieja
      • Santurce, Puerto Rico, 00908
        • San Juan AIDS Program
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35203
        • Sorra Research Ctr Inc / Med Forum
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Hill Top Research Ltd
      • Tucson, Arizona, United States, 85712
        • Arizona Clinical Research Ctr Inc
    • California
      • Long Beach, California, United States, 90822
        • Dermatology SVC - VAMC
      • Los Angeles, California, United States, 90059
        • King - Drew Med Ctr / Dept of Dermatology
      • Oakland, California, United States, 94609
        • Summit Med Ctr / Adult Immunology Clinic
      • Palm Springs, California, United States, 92262
        • ViRx Inc
      • San Francisco, California, United States, 94109
        • ViRx Inc
      • San Francisco, California, United States, 94117
        • Conant Med Ctr
      • Sylmar, California, United States, 91342
        • Olive View Med Ctr
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • Novum Inc
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • IDC Research Initiative
      • Fort Lauderdale, Florida, United States, 33316
        • Gary Richmond MD
      • Fort Myers, Florida, United States, 33901
        • Dr Robert Schwartz
      • Tampa, Florida, United States, 33614
        • Infectious Disease Research Institute Inc
      • Vero Beach, Florida, United States, 32960
        • Treasure Coast Infectious Disease Consultants
    • Illinois
      • Chicago, Illinois, United States, 60064
        • Veterans Affairs Med Ctr of North Chicago
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins Univ / Division of Infectious Disease
      • Baltimore, Maryland, United States, 21229
        • Saint Agnes Healthcare / Dept of Surgery
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts Gen Hosp - Warren 505
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Medicine / Infectious Diseases
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai Med Ctr
      • New York, New York, United States, 10016
        • New York Univ Med Ctr
      • New York, New York, United States, 10032
        • Columbia Presbyterian Med Ctr
      • New York, New York, United States, 10011
        • AIDS Ctr / Saint Vincents Hosp and Med Ctr
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19103
        • Paddington Testing Co Inc
    • Texas
      • Austin, Texas, United States, 78705
        • Austin Infectious Disease Consultants
      • Dallas, Texas, United States, 75219
        • N Texas Ctr for AIDS & Clin Rsch
      • Houston, Texas, United States, 77030
        • Division of Infectious Diseases / Univ of Texas - Houston
    • Virginia
      • Arlington, Virginia, United States, 22205
        • Dr Robert Holman
    • Washington
      • Seattle, Washington, United States, 98122
        • Univ of Washington Virology Research Clinic
      • Seattle, Washington, United States, 98122
        • Novum Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaman Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

February 1, 1998

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 270A
  • 96-867-DE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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