Search / 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)

Launched by SHAMAN PHARMACEUTICALS · Aug 30, 2001

Trial Information

Current as of December 06, 2024

Completed

Keywords

Aids Related Opportunistic Infections Herpes Simplex Drug Therapy, Combination Acyclovir Antiviral Agents Gels Sp 303

ClinConnect Summary

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...

Gender

ALL

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.

About Shaman Pharmaceuticals

Shaman Pharmaceuticals is a biopharmaceutical company dedicated to the discovery and development of innovative therapies derived from traditional medicinal plants. With a focus on leveraging cutting-edge research and advanced drug formulation techniques, Shaman Pharmaceuticals aims to address unmet medical needs across various therapeutic areas. The company is committed to rigorous clinical trial methodologies and regulatory compliance, ensuring the safety and efficacy of its products while fostering collaborations with academic institutions and industry partners to enhance its research capabilities and drive sustainable growth.

Locations

New York, New York, United States

New York, New York, United States

Sylmar, California, United States

Dallas, Texas, United States

New York, New York, United States

San Francisco, California, United States

Tampa, Florida, United States

Fort Lauderdale, Florida, United States

Washington, District Of Columbia, United States

Austin, Texas, United States

Seattle, Washington, United States

Ponce, , Puerto Rico

Birmingham, Alabama, United States

Scottsdale, Arizona, United States

Tucson, Arizona, United States

Long Beach, California, United States

Los Angeles, California, United States

Oakland, California, United States

Palm Springs, California, United States

San Francisco, California, United States

Altamonte Springs, Florida, United States

Fort Myers, Florida, United States

Vero Beach, Florida, United States

Chicago, Illinois, United States

Baltimore, Maryland, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Minneapolis, Minnesota, United States

New York, New York, United States

Philadelphia, Pennsylvania, United States

Houston, Texas, United States

Arlington, Virginia, United States

Seattle, Washington, United States

Santurce, , Puerto Rico

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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