The Healthy Life Choices Project in HIV-Positive Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

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

History of Changes

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 Primary Purpose: Educational/Counseling/Training

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea HIV/AIDS

U.S. FDA Resources

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 (Adult, Senior)
Sexes Eligible for Study:	All
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

National Institute of Nursing Research (NINR)

More Information


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

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 Diarrhea Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases	Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Signs and Symptoms, Digestive Signs and Symptoms

ClinicalTrials.gov processed this record on September 21, 2017

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