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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