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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002408
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1999
  Purpose

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 Intervention Phase
Diarrhea
HIV Infections
Drug: Crofelemer
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 300
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002408

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

No publications provided

ClinicalTrials.gov Identifier: NCT00002408     History of Changes
Other Study ID Numbers: 293A, 37,554-210
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Diarrhea
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Syndrome
Diarrhea
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014