A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Orally Administered SP-303 for the Treatment of Diarrhea in Acquired Immunodeficiency Syndrome (AIDS) Patients

Overview

To evaluate the efficacy, safety, and durability of response of SP-303 in decreasing stool weight in AIDS patients with diarrhea over 6 days of treatment.

Study Type

  • Study Type: Interventional
  • Study Design
    • Primary Purpose: Treatment
    • Masking: Double

Interventions

  • Drug: Crofelemer

Participating in This Clinical Trial

Inclusion Criteria Patients must have:

  • HIV infection meeting CDC criteria for AIDS. – History of diarrhea for greater than or equal to 14 days prior to screening period (Day 1). Required: – On stable medical regimen.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shaman Pharmaceuticals

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