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) - Full Text View

Sponsor:	Shaman Pharmaceuticals
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002186

Purpose

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	Intervention
Herpes Simplex HIV Infections	Drug: Crofelemer Drug: Acyclovir

Study Type:	Interventional
Study Design:	Treatment, Double-Blind, Safety Study
Official Title:	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)

Resource links provided by NLM:

MedlinePlus related topics: AIDS Herpes Simplex

Drug Information available for: Acyclovir Acyclovir sodium SP 303

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:

400

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002186

Hide Study Locations

Locations

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

Sponsors and Collaborators

Shaman Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	270A, 96-867-DE
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002186 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

AIDS-Related Opportunistic Infections
Herpes Simplex
Drug Therapy, Combination
Acyclovir

Antiviral Agents
Gels
SP 303

Additional relevant MeSH terms:

Herpes Simplex
Anti-Infective Agents
Communicable Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Skin Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection
Antiviral Agents
Pharmacologic Actions

Immunologic Deficiency Syndromes
Herpesviridae Infections
Skin Diseases, Viral
Virus Diseases
Skin Diseases, Infectious
Acyclovir
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
DNA Virus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on November 30, 2009