The Healthy Life Choices Project in HIV-Positive Patients
Recruitment status was Recruiting
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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 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
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 |
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 March 07, 2013