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)

Study Overview
=================
Brief Summary
-----------------
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.

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.

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)

Conditions
-----------------
Herpes Simplex, HIV Infections

Intervention / Treatment
-----------------
* Drug: Crofelemer
* Drug: Acyclovir


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Crofelemer|nan|
|Drug: Acyclovir|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AIDS-Related Opportunistic Infections, Herpes Simplex, Drug Therapy, Combination, Acyclovir, Antiviral Agents, Gels, SP 303