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

Shaman Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Diarrhea; HIV Infections

Treatments: Drug: Crofelemer

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002408

37,554-210

293A

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.