Clinical trial NCT00002186: 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)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Herpes Simplex
HIV Infections
Keywords: AIDS-Related Opportunistic Infections
Herpes Simplex
Drug Therapy, Combination
Acyclovir
Antiviral Agents
Gels
SP 303
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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 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.

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