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
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Single Blind
Primary Purpose: Educational/Counseling/Training

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00017810     History of Changes
Other Study ID Numbers: 6510, NIH 2652
Study First Received: June 13, 2001
Last Updated: December 8, 2005
Health Authority: Unspecified

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Diarrhea
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014