- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002408
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
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
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Ponce, Puerto Rico, 00731
- Hosp Regional de Ponce
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San Juan, Puerto Rico, 00909
- Clinical Research Puerto Rico Inc
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Arizona
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Scottsdale, Arizona, United States, 85251
- Hill Top Research Ltd
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Scottsdale, Arizona, United States, 85251
- Phoenix Living Ctr
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California
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Los Angeles, California, United States, 90095
- UCLA CARE Ctr
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Palo Alto, California, United States, 94304
- AIDS Research Ctr / Dept of Veterans Affairs
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San Francisco, California, United States, 94110
- San Francisco Gen Hosp
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West Hollywood, California, United States, 90046
- Lynn House Hospice
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West Hollywood, California, United States, 90069
- AIDS Research Alliance
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District of Columbia
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Washington, District of Columbia, United States, 20059
- Howard Univ
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Washington, District of Columbia, United States, 20060
- GCRC
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Florida
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Coral Gables, Florida, United States, 33146
- Community CRI of South Florida
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Maitland, Florida, United States, 32751
- Central Florida Research Initiative
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Miami, Florida, United States, 33157
- Deering Hosp
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Orlando, Florida, United States, 32808
- Rosemont Health Care Ctr
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Tampa, Florida, United States, 33609
- Ctr for Quality Care
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Tampa, Florida, United States, 33609
- Mem Hosp of Tampa
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Georgia
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Atlanta, Georgia, United States, 30327
- Phillip Branchman
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Decatur, Georgia, United States, 30033
- Insite Clinical Trials
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Illinois
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Oak Park, Illinois, United States, 60304
- Oak Park Hosp
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Indiana
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Indianapolis, Indiana, United States, 462025250
- Indiana Univ Med Ctr
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Louisiana
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Kenner, Louisiana, United States, 70062
- New Orleans Pharmaceutical Research
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Maryland
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Baltimore, Maryland, United States, 212875554
- Johns Hopkins Hosp
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Massachusetts
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Boston, Massachusetts, United States, 02111
- New England Med Ctr
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Michigan
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Detroit, Michigan, United States, 48201
- Wayne State Univ
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Minnesota
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Minneapolis, Minnesota, United States, 55415
- Hennepin County Med Ctr
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St. Paul, Minnesota, United States, 55101
- Regions Hosp
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Missouri
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St. Louis, Missouri, United States, 63110
- Washington Univ School of Medicine
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New York
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Brooklyn, New York, United States, 112123198
- Brookdale Univ Hosp and Med Ctr
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New York, New York, United States, 10011
- Saint Vincents Hosp
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North Carolina
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Raleigh, North Carolina, United States, 27610
- Wake Med CRI
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Texas
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Houston, Texas, United States, 77004
- Joseph Gathe
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San Antonio, Texas, United States, 78284
- GCRC - VA Hosp
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San Antonio, Texas, United States, 78284
- South Texas Veterans Health Care System
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Washington
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Seattle, Washington, United States, 98112
- Bailey Boushay House
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Seattle, Washington, United States, 98125
- Rosehedge House
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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.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immune System Diseases
- Signs and Symptoms, Digestive
- Slow Virus Diseases
- HIV Infections
- Diarrhea
- Acquired Immunodeficiency Syndrome
- Immunologic Deficiency Syndromes
Other Study ID Numbers
- 293A
- 37,554-210
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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