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.

Sponsored by:	Shaman Pharmaceuticals
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002186

Purpose

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.

Condition	Intervention
Herpes Simplex HIV Infections	Drug: Crofelemer Drug: Acyclovir

MedlinePlus related topics: AIDS Herpes Simplex

Drug Information available for: Acyclovir Acyclovir sodium SP 303

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Double-Blind, Safety Study
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)

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:

400

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002186

Show 34 Study Locations

Sponsors and Collaborators

Shaman Pharmaceuticals

More Information

Study ID Numbers:	270A, 96-867-DE
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002186
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

AIDS-Related Opportunistic Infections
Herpes Simplex
Drug Therapy, Combination
Acyclovir

Antiviral Agents
Gels
SP 303

Study placed in the following topic categories:

Herpes Simplex
Opportunistic Infections
Sexually Transmitted Diseases, Viral
Skin Diseases
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Recurrence
Herpesviridae Infections

Virus Diseases
Skin Diseases, Infectious
Acyclovir
HIV Infections
AIDS-Related Opportunistic Infections
Sexually Transmitted Diseases
DNA Virus Infections
Retroviridae Infections

Additional relevant MeSH terms:

Skin Diseases, Viral
Anti-Infective Agents
Communicable Diseases
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases

Therapeutic Uses
Lentivirus Infections
Infection
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009