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
2 other identifiers
interventional
300
2 countries
36
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
April 1, 1999
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Hill Top Research Ltd
Scottsdale, Arizona, 85251, United States
Phoenix Living Ctr
Scottsdale, Arizona, 85251, United States
UCLA Care Ctr
Los Angeles, California, 90095, 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
Lynn House Hospice
West Hollywood, California, 90046, United States
AIDS Research Alliance
West Hollywood, California, 90069, United States
Howard Univ
Washington D.C., District of Columbia, 20059, United States
GCRC
Washington D.C., District of Columbia, 20060, United States
Community CRI of South Florida
Coral Gables, Florida, 33146, United States
Central Florida Research Initiative
Maitland, Florida, 32751, United States
Deering Hosp
Miami, Florida, 33157, 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
Phillip Branchman
Atlanta, Georgia, 30327, United States
Insite Clinical Trials
Decatur, Georgia, 30033, United States
Oak Park Hosp
Oak Park, Illinois, 60304, United States
Indiana Univ Med Ctr
Indianapolis, Indiana, 462025250, United States
New Orleans Pharmaceutical Research
Kenner, Louisiana, 70062, United States
Johns Hopkins Hosp
Baltimore, Maryland, 212875554, United States
New England Med Ctr
Boston, Massachusetts, 02111, United States
Wayne State Univ
Detroit, Michigan, 48201, United States
Hennepin County Med Ctr
Minneapolis, Minnesota, 55415, United States
Regions Hosp
Saint Paul, Minnesota, 55101, United States
Washington Univ School of Medicine
St Louis, Missouri, 63110, United States
Brookdale Univ Hosp and Med Ctr
Brooklyn, New York, 112123198, United States
Saint Vincents Hosp
New York, New York, 10011, United States
Wake Med CRI
Raleigh, North Carolina, 27610, United States
Joseph Gathe
Houston, Texas, 77004, United States
GCRC - VA Hosp
San Antonio, Texas, 78284, United States
South Texas Veterans Health Care System
San Antonio, Texas, 78284, United States
Bailey Boushay House
Seattle, Washington, 98112, United States
Rosehedge House
Seattle, Washington, 98125, United States
Hosp Regional de Ponce
Ponce, 00731, Puerto Rico
Clinical Research Puerto Rico Inc
San Juan, 00909, Puerto Rico