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)

Completed · Not applicable

Conditions studied: Herpes Simplex, HIV Infections

In brief

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.

Key facts

Study ID

NCT00002186

Run by

Shaman Pharmaceuticals

People needed

400

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• Sorra Research Ctr Inc / Med Forum — Birmingham, Alabama, United States
• Hill Top Research Ltd — Scottsdale, Arizona, United States
• Arizona Clinical Research Ctr Inc — Tucson, Arizona, United States
• Dermatology SVC - VAMC — Long Beach, California, United States
• King - Drew Med Ctr / Dept of Dermatology — Los Angeles, California, United States
• Summit Med Ctr / Adult Immunology Clinic — Oakland, California, United States
• ViRx Inc — Palm Springs, California, United States
• ViRx Inc — San Francisco, California, United States
• Conant Med Ctr — San Francisco, California, United States
• Olive View Med Ctr — Sylmar, California, United States
• Novum Inc — Washington D.C., District of Columbia, United States
• IDC Research Initiative — Altamonte Springs, Florida, United States
• Gary Richmond MD — Fort Lauderdale, Florida, United States
• Dr Robert Schwartz — Fort Myers, Florida, United States
• Infectious Disease Research Institute Inc — Tampa, Florida, United States
• Treasure Coast Infectious Disease Consultants — Vero Beach, Florida, United States
• Veterans Affairs Med Ctr of North Chicago — Chicago, Illinois, United States
• Johns Hopkins Univ / Division of Infectious Disease — Baltimore, Maryland, United States
• Saint Agnes Healthcare / Dept of Surgery — Baltimore, Maryland, United States
• Massachusetts Gen Hosp - Warren 505 — Boston, Massachusetts, United States
• Medicine / Infectious Diseases — Minneapolis, Minnesota, United States
• AIDS Ctr / Saint Vincents Hosp and Med Ctr — New York, New York, United States
• New York Univ Med Ctr — New York, New York, United States
• Mount Sinai Med Ctr — New York, New York, United States
• Columbia Presbyterian Med Ctr — New York, New York, United States

Full record on ClinicalTrials.gov

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