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

Last updated: June 23, 2005
Sponsor: Shaman Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Hiv Infections

Hyponatremia

Colic

Treatment

N/A

Clinical Study ID

NCT00002408
293A
37,554-210
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 Design

Total Participants: 300
Study Start date:
Estimated Completion Date:

Connect with a study center

  • Hosp Regional de Ponce

    Ponce, 00731
    Puerto Rico

    Site Not Available

  • Clinical Research Puerto Rico Inc

    San Juan, 00909
    Puerto Rico

    Site Not Available

  • Hill Top Research Ltd

    Scottsdale, Arizona 85251
    United States

    Site Not Available

  • Phoenix Living Ctr

    Scottsdale, Arizona 85251
    United States

    Site Not Available

  • UCLA Care Ctr

    Los Angeles, California 90095
    United States

    Site Not Available

  • AIDS Research Ctr / Dept of Veterans Affairs

    Palo Alto, California 94304
    United States

    Site Not Available

  • San Francisco Gen Hosp

    San Francisco, California 94110
    United States

    Site Not Available

  • AIDS Research Alliance

    West Hollywood, California 90069
    United States

    Site Not Available

  • Lynn House Hospice

    West Hollywood, California 90046
    United States

    Site Not Available

  • GCRC

    Washington, District of Columbia 20060
    United States

    Site Not Available

  • Howard Univ

    Washington, District of Columbia 20059
    United States

    Site Not Available

  • Community CRI of South Florida

    Coral Gables, Florida 33146
    United States

    Site Not Available

  • Central Florida Research Initiative

    Maitland, Florida 32751
    United States

    Site Not Available

  • Deering Hosp

    Miami, Florida 33157
    United States

    Site Not Available

  • Rosemont Health Care Ctr

    Orlando, Florida 32808
    United States

    Site Not Available

  • Ctr for Quality Care

    Tampa, Florida 33609
    United States

    Site Not Available

  • Mem Hosp of Tampa

    Tampa, Florida 33609
    United States

    Site Not Available

  • Phillip Branchman

    Atlanta, Georgia 30327
    United States

    Site Not Available

  • Insite Clinical Trials

    Decatur, Georgia 30033
    United States

    Site Not Available

  • Oak Park Hosp

    Oak Park, Illinois 60304
    United States

    Site Not Available

  • Indiana Univ Med Ctr

    Indianapolis, Indiana 462025250
    United States

    Site Not Available

  • New Orleans Pharmaceutical Research

    Kenner, Louisiana 70062
    United States

    Site Not Available

  • Johns Hopkins Hosp

    Baltimore, Maryland 212875554
    United States

    Site Not Available

  • New England Med Ctr

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Wayne State Univ

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Hennepin County Med Ctr

    Minneapolis, Minnesota 55415
    United States

    Site Not Available

  • Regions Hosp

    St. Paul, Minnesota 55101
    United States

    Site Not Available

  • Washington Univ School of Medicine

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • Brookdale Univ Hosp and Med Ctr

    Brooklyn, New York 112123198
    United States

    Site Not Available

  • Saint Vincents Hosp

    New York, New York 10011
    United States

    Site Not Available

  • Wake Med CRI

    Raleigh, North Carolina 27610
    United States

    Site Not Available

  • Joseph Gathe

    Houston, Texas 77004
    United States

    Site Not Available

  • GCRC - VA Hosp

    San Antonio, Texas 78284
    United States

    Site Not Available

  • South Texas Veterans Health Care System

    San Antonio, Texas 78284
    United States

    Site Not Available

  • Bailey Boushay House

    Seattle, Washington 98112
    United States

    Site Not Available

  • Rosehedge House

    Seattle, Washington 98125
    United States

    Site Not Available

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