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)

HIV Infections Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002186
• Other study ID #: 270A
• Secondary ID: 96-867-DE
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: February 1998
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 400
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• Herpes Simplex
• HIV Infections
• Immunologic Deficiency Syndromes
• Infection

Intervention

Drug:
• Crofelemer

• Acyclovir

Locations

Country	Name	City	State
Puerto Rico	Hosp Regional de Ponce - Area Vieja	Ponce
Puerto Rico	San Juan AIDS Program	Santurce
United States	IDC Research Initiative	Altamonte Springs	Florida
United States	Dr Robert Holman	Arlington	Virginia
United States	Austin Infectious Disease Consultants	Austin	Texas
United States	Johns Hopkins Univ / Division of Infectious Disease	Baltimore	Maryland
United States	Saint Agnes Healthcare / Dept of Surgery	Baltimore	Maryland
United States	Sorra Research Ctr Inc / Med Forum	Birmingham	Alabama
United States	Massachusetts Gen Hosp - Warren 505	Boston	Massachusetts
United States	Veterans Affairs Med Ctr of North Chicago	Chicago	Illinois
United States	N Texas Ctr for AIDS & Clin Rsch	Dallas	Texas
United States	Gary Richmond MD	Fort Lauderdale	Florida
United States	Dr Robert Schwartz	Fort Myers	Florida
United States	Division of Infectious Diseases / Univ of Texas - Houston	Houston	Texas
United States	Dermatology SVC - VAMC	Long Beach	California
United States	King - Drew Med Ctr / Dept of Dermatology	Los Angeles	California
United States	Medicine / Infectious Diseases	Minneapolis	Minnesota
United States	AIDS Ctr / Saint Vincents Hosp and Med Ctr	New York	New York
United States	Columbia Presbyterian Med Ctr	New York	New York
United States	Mount Sinai Med Ctr	New York	New York
United States	New York Univ Med Ctr	New York	New York
United States	Summit Med Ctr / Adult Immunology Clinic	Oakland	California
United States	ViRx Inc	Palm Springs	California
United States	Paddington Testing Co Inc	Philadelphia	Pennsylvania
United States	Conant Med Ctr	San Francisco	California
United States	ViRx Inc	San Francisco	California
United States	Hill Top Research Ltd	Scottsdale	Arizona
United States	Novum Inc	Seattle	Washington
United States	Univ of Washington Virology Research Clinic	Seattle	Washington
United States	Olive View Med Ctr	Sylmar	California
United States	Infectious Disease Research Institute Inc	Tampa	Florida
United States	Arizona Clinical Research Ctr Inc	Tucson	Arizona
United States	Treasure Coast Infectious Disease Consultants	Vero Beach	Florida
United States	Novum Inc	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Shaman Pharmaceuticals

Countries where clinical trial is conducted

United States,  Puerto Rico,