The Healthy Life Choices Project in HIV-Positive Patients - Tabular View

Tracking Information
First Received Date ^ICMJE	June 13, 2001
Last Updated Date
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00017810 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	The Healthy Life Choices Project in HIV-Positive Patients
Official Title ^ICMJE
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 ^ICMJE	Interventional
Study Design ^ICMJE	Educational/Counseling/Training, Randomized, Single Blind
Condition ^ICMJE	Diarrhea HIV Infections
Intervention ^ICMJE	Behavioral: Dietary intervention
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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 ^ICMJE
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00017810
Responsible Party
Study ID Numbers ^ICMJE	6510, NIH 2652
Study Sponsor ^ICMJE	National Institute of Nursing Research (NINR)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute of Nursing Research (NINR)
Verification Date	April 2001
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP