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

NCT ID: NCT00002408

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Diarrhea HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Crofelemer

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shaman Pharmaceuticals

INDUSTRY

Sponsor Role lead

Locations

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Hill Top Research Ltd

Scottsdale, Arizona, United States

Site Status

Phoenix Living Ctr

Scottsdale, Arizona, United States

Site Status

UCLA Care Ctr

Los Angeles, California, United States

Site Status

AIDS Research Ctr / Dept of Veterans Affairs

Palo Alto, California, United States

Site Status

San Francisco Gen Hosp

San Francisco, California, United States

Site Status

Lynn House Hospice

West Hollywood, California, United States

Site Status

AIDS Research Alliance

West Hollywood, California, United States

Site Status

Howard Univ

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

Site Status

GCRC

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

Site Status

Community CRI of South Florida

Coral Gables, Florida, United States

Site Status

Central Florida Research Initiative

Maitland, Florida, United States

Site Status

Deering Hosp

Miami, Florida, United States

Site Status

Rosemont Health Care Ctr

Orlando, Florida, United States

Site Status

Ctr for Quality Care

Tampa, Florida, United States

Site Status

Mem Hosp of Tampa

Tampa, Florida, United States

Site Status

Phillip Branchman

Atlanta, Georgia, United States

Site Status

Insite Clinical Trials

Decatur, Georgia, United States

Site Status

Oak Park Hosp

Oak Park, Illinois, United States

Site Status

Indiana Univ Med Ctr

Indianapolis, Indiana, United States

Site Status

New Orleans Pharmaceutical Research

Kenner, Louisiana, United States

Site Status

Johns Hopkins Hosp

Baltimore, Maryland, United States

Site Status

New England Med Ctr

Boston, Massachusetts, United States

Site Status

Wayne State Univ

Detroit, Michigan, United States

Site Status

Hennepin County Med Ctr

Minneapolis, Minnesota, United States

Site Status

Regions Hosp

Saint Paul, Minnesota, United States

Site Status

Washington Univ School of Medicine

St Louis, Missouri, United States

Site Status

Brookdale Univ Hosp and Med Ctr

Brooklyn, New York, United States

Site Status

Saint Vincents Hosp

New York, New York, United States

Site Status

Wake Med CRI

Raleigh, North Carolina, United States

Site Status

Joseph Gathe

Houston, Texas, United States

Site Status

GCRC - VA Hosp

San Antonio, Texas, United States

Site Status

South Texas Veterans Health Care System

San Antonio, Texas, United States

Site Status

Bailey Boushay House

Seattle, Washington, United States

Site Status

Rosehedge House

Seattle, Washington, United States

Site Status

Hosp Regional de Ponce

Ponce, , Puerto Rico

Site Status

Clinical Research Puerto Rico Inc

San Juan, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

Other Identifiers

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37,554-210

Identifier Type: -

Identifier Source: secondary_id

293A

Identifier Type: -

Identifier Source: org_study_id