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The Healthy Life Choices Project in HIV-Positive Patients

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ClinicalTrials.gov Identifier: NCT00017810
Recruitment Status : Unknown
Verified April 2001 by National Institute of Nursing Research (NINR).
Recruitment status was:  Recruiting
First Posted : June 14, 2001
Last Update Posted : December 9, 2005
Sponsor:
Information provided by:
National Institute of Nursing Research (NINR)

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Diarrhea HIV Infections Behavioral: Dietary intervention Phase 1

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Single
Primary Purpose: Educational/Counseling/Training

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00017810     History of Changes
Other Study ID Numbers: 6510
NIH 2652
First Posted: June 14, 2001    Key Record Dates
Last Update Posted: December 9, 2005
Last Verified: April 2001

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