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

June 23, 2005 updated by: Shaman Pharmaceuticals
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 Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ponce, Puerto Rico, 00731
        • Hosp Regional de Ponce
      • San Juan, Puerto Rico, 00909
        • Clinical Research Puerto Rico Inc
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Hill Top Research Ltd
      • Scottsdale, Arizona, United States, 85251
        • Phoenix Living Ctr
    • California
      • Los Angeles, California, United States, 90095
        • UCLA CARE Ctr
      • Palo Alto, California, United States, 94304
        • AIDS Research Ctr / Dept of Veterans Affairs
      • San Francisco, California, United States, 94110
        • San Francisco Gen Hosp
      • West Hollywood, California, United States, 90046
        • Lynn House Hospice
      • West Hollywood, California, United States, 90069
        • AIDS Research Alliance
    • District of Columbia
      • Washington, District of Columbia, United States, 20059
        • Howard Univ
      • Washington, District of Columbia, United States, 20060
        • GCRC
    • Florida
      • Coral Gables, Florida, United States, 33146
        • Community CRI of South Florida
      • Maitland, Florida, United States, 32751
        • Central Florida Research Initiative
      • Miami, Florida, United States, 33157
        • Deering Hosp
      • Orlando, Florida, United States, 32808
        • Rosemont Health Care Ctr
      • Tampa, Florida, United States, 33609
        • Ctr for Quality Care
      • Tampa, Florida, United States, 33609
        • Mem Hosp of Tampa
    • Georgia
      • Atlanta, Georgia, United States, 30327
        • Phillip Branchman
      • Decatur, Georgia, United States, 30033
        • Insite Clinical Trials
    • Illinois
      • Oak Park, Illinois, United States, 60304
        • Oak Park Hosp
    • Indiana
      • Indianapolis, Indiana, United States, 462025250
        • Indiana Univ Med Ctr
    • Louisiana
      • Kenner, Louisiana, United States, 70062
        • New Orleans Pharmaceutical Research
    • Maryland
      • Baltimore, Maryland, United States, 212875554
        • Johns Hopkins Hosp
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • New England Med Ctr
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State Univ
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Med Ctr
      • St. Paul, Minnesota, United States, 55101
        • Regions Hosp
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington Univ School of Medicine
    • New York
      • Brooklyn, New York, United States, 112123198
        • Brookdale Univ Hosp and Med Ctr
      • New York, New York, United States, 10011
        • Saint Vincents Hosp
    • North Carolina
      • Raleigh, North Carolina, United States, 27610
        • Wake Med CRI
    • Texas
      • Houston, Texas, United States, 77004
        • Joseph Gathe
      • San Antonio, Texas, United States, 78284
        • GCRC - VA Hosp
      • San Antonio, Texas, United States, 78284
        • South Texas Veterans Health Care System
    • Washington
      • Seattle, Washington, United States, 98112
        • Bailey Boushay House
      • Seattle, Washington, United States, 98125
        • Rosehedge House

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

April 1, 1999

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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