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The Healthy Life Choices Project in HIV-Positive Patients
This study is currently recruiting participants.
Verified by National Institute of Nursing Research (NINR), April 2001
Sponsored by: National Institute of Nursing Research (NINR)
Information provided by: National Institute of Nursing Research (NINR)
ClinicalTrials.gov Identifier: NCT00017810
  Purpose

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).


Condition Intervention Phase
Diarrhea
HIV Infections
Behavioral: Dietary intervention
Phase I

MedlinePlus related topics: AIDS Diarrhea
U.S. FDA Resources
Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Single Blind

Further study details as provided by National Institute of Nursing Research (NINR):

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00017810

Locations
United States, New York
Columbia Univ School of Nursing / Center for AIDS Research Recruiting
New York, New York, United States, 10032
Contact: Ann Chung     212-305-0216     amc103@columbia.edu    
Sponsors and Collaborators
  More Information

Study ID Numbers: 6510, NIH 2652
Study First Received: June 13, 2001
ClinicalTrials.gov Identifier: NCT00017810  
Health Authority: Unspecified

Keywords provided by National Institute of Nursing Research (NINR):
complementary therapies
Behavior Therapy
Diarrhea
Diet Therapy
Food
HIV Seropositivity

Study placed in the following topic categories:
Virus Diseases
Signs and Symptoms
Sexually Transmitted Diseases, Viral
Diarrhea
Signs and Symptoms, Digestive
HIV Seropositivity
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Healthy
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009