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The Healthy Life Choices Project in HIV-Positive Patients

This study is currently recruiting participants.
Information provided by National Institute of Nursing Research (NINR)

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Descriptive Information Fields
Brief Title  The Healthy Life Choices Project in HIV-Positive Patients
Official Title 
Brief Summary

The purpose of this study is to see whether changes in diet and behavior lessen the number of times HIV-positive people get diarrhea (soft or loose stools).

Detailed Description

This is a Phase I trial (a study to evaluate effectiveness in a small number of patients).

Patients will be randomized (like tossing a coin) to 1 of 2 groups:

Group 1: Patients will go on a specific diet and will be taught new behavior skills.

Group 2: Patients will be taught ways to take care of themselves and will be given general nutrition information.

Patients also will be grouped based on the cause of their diarrhea (food absorption problems or anti-HIV medication side effects). Patients will make a note of when they have bowel movements and will write down all food and drugs they take for the entire study. They will be interviewed at entry and at Weeks 1, 2, 3, 8, 16, and 24. Patients will be paid for participating in this study.

Study Phase Phase I
Study Type  Interventional
Study Design  Educational/Counseling/Training, Randomized, Single Blind
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Diarrhea
HIV Infections
Intervention  Behavioral: Dietary intervention
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment 
Start Date 
Completion Date
Eligibility Criteria 

Inclusion Criteria:

  • Have HIV infection or AIDS.
  • Have diarrhea an average of 3 times a day for at least 3 weeks.
  • Have a negative stool test.
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00017810
Organization ID 6510
Secondary IDs †† NIH 2652
Study Sponsor  National Institute of Nursing Research (NINR)
Collaborators ††
Investigators 
Information Provided By National Institute of Nursing Research (NINR)
Verification Date April 2001
First Received Date  June 13, 2001
Last Updated Date

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




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