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.

Condition	Treatment or Intervention	Phase
Diarrhea HIV Infections	Drug: Crofelemer	Phase III

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.

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

Study ID Numbers:  293A; 37,554-210
Record last reviewed:  April 1999
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002408
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08