The Healthy Life Choices Project in HIV-Positive Patients
Completed · Phase 2
Conditions studied: Diarrhea, HIV Infections
In brief
This randomized clinical trial is designed to determine the efficacy of a dietary intervention to reduce the frequency of bowel movements and improve stool consistency as compared with subjects assigned to a control group. The study enrolled HIV patients with a history of three or more episodes of diarrhea for 3 weeks or more. The purpose of this study was to compare the efficacy of a combined behavioral dietary intervention using normal foods (Condition 1: treatment) with HIV self-care (Condition 2: control) to reduce the frequency and improve the consistency of bowel movements after 3 weeks and 24 weeks of study intervention.
Key facts
- Study ID
- NCT00017810
- Run by
- Columbia University
- People needed
- 75
- Starts
- 1996-09-01
- Expected to finish
- 2003-03-01
- Last updated by the study team
- 2021-08-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18 years of age or older
- diagnosed with HIV or AIDS based on the Centers for Disease Control and Prevention criteria
- experienced a minimum of three episodes of loose, watery, or liquid stools in a 24-hour period for at least 3 weeks
- provide verification from their primary care provider of HIV status, chronic diarrhea history, documentation of medical evaluations completed
- laboratory confirmation that stool samples were negative for pathogens
- patients who were taking antidiarrheal agents were required to be on a stable regimen (same drug, dosage, and frequency) for at least 7 days before entry into the study and still meet diarrhea frequency and consistency criteria
- antiretroviral agents taken to manage HIV required a stable regimen (same drugs, dosage, and frequency) for at least 8 weeks before study entry
- patients were required to complete a mini-mental state examination, obtaining a score of 24 or higher
You may not qualify if…
- not meeting any of the above criteria
Where it is running
- Columbia Univ School of Nursing / Center for AIDS Research — New York, New York, United States
Full record on ClinicalTrials.gov
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