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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.
Study NCT00002408.   Last updated on June 23, 2005.   Information provided by NIH AIDS Clinical Trials Information Service

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Descriptive Information Fields
Brief 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
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
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.

Detailed Description
Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Double-Blind, Safety Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Diarrhea
HIV Infections
Intervention  Drug: Crofelemer
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  300
Start Date 
Completion Date
Eligibility 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.

Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States,   Puerto Rico
Administrative Information Fields
NCT ID  NCT00002408
Organization ID 293A
Secondary IDs †† 37,554-210
Study Sponsor  Shaman Pharmaceuticals
Collaborators ††
Investigators 
Information Provided By NIH AIDS Clinical Trials Information Service
Verification Date April 1999
First Received Date  November 2, 1999
Last Updated Date June 23, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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