The Healthy Life Choices Project in HIV-Positive Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2001 by National Institute of Nursing Research (NINR).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute of Nursing Research (NINR)
ClinicalTrials.gov Identifier:
NCT00017810
First received: June 13, 2001
Last updated: December 8, 2005
Last verified: April 2001

June 13, 2001
December 8, 2005
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00017810 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Healthy Life Choices Project in HIV-Positive Patients
Not Provided

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).

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.

Interventional
Phase 1
Allocation: Randomized
Masking: Single Blind
Primary Purpose: Educational/Counseling/Training
  • Diarrhea
  • HIV Infections
Behavioral: Dietary intervention
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
Not Provided
Not Provided
Not Provided

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.
Both
18 Years and older
No
United States
 
NCT00017810
6510, NIH 2652
Not Provided
Not Provided
National Institute of Nursing Research (NINR)
Not Provided
Not Provided
National Institute of Nursing Research (NINR)
April 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP