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)

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002186
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: February 1998

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002186 on ClinicalTrials.gov Archive Site
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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)
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)

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.

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.

Interventional
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Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
  • Herpes Simplex
  • HIV Infections
  • Drug: Crofelemer
  • Drug: Acyclovir
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
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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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00002186
270A, 96-867-DE
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Shaman Pharmaceuticals
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NIH AIDS Clinical Trials Information Service
February 1998

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP