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)

S

Shaman Pharmaceuticals

Status

Completed

Conditions

Herpes Simplex
HIV Infections

Treatments

Drug: Crofelemer
Drug: Acyclovir

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002186
96-867-DE
270A

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial contacts and locations

34

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Data sourced from clinicaltrials.gov

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