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 Pharmaceuticals300 enrolled

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

INTERVENTIONAL

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

300

Conditions

Diarrhea HIV Infections

Interventions

CrofelemerDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (36)

Data from ClinicalTrials.gov

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Hill Top Research Ltd

Scottsdale, Arizona, United States

Phoenix Living Ctr

Scottsdale, Arizona, United States

UCLA Care Ctr

Los Angeles, California, United States

AIDS Research Ctr / Dept of Veterans Affairs

Palo Alto, California, United States

San Francisco Gen Hosp

San Francisco, California, United States

Lynn House Hospice

West Hollywood, California, United States

AIDS Research Alliance

West Hollywood, California, United States

Howard Univ

Washington D.C., District of Columbia, United States

GCRC

Washington D.C., District of Columbia, United States

Community CRI of South Florida

Coral Gables, Florida, United States

...and 26 more locations