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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001077 |
To compare a caloric supplement containing peptides and medium-chain triglycerides, a caloric supplement containing whole protein and long-chain triglycerides, and no caloric supplement for the prevention of weight loss in individuals with AIDS who take a daily multivitamin and mineral supplement.
Condition | Intervention |
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HIV Infections HIV Wasting Syndrome |
Dietary Supplement: Multivitamin and mineral supplements Dietary Supplement: Peptamen Dietary Supplement: NuBasics |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | An Open-Label, Randomized, Three-Arm, Comparative Trial of a Caloric Supplement With Peptides and Medium-Chain Triglycerides Versus a Caloric Supplement With Whole Protein and Long-Chain Triglycerides Versus No Caloric Supplement for the Prevention of Weight Loss in Individuals With AIDS Who Take a Daily Multivitamin and Mineral Supplement |
Blood collection
Enrollment: | 536 |
Study Start Date: | June 1996 |
Primary Completion Date: | June 1998 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
Participants will receive peptamen drinks and multivitamin and mineral supplements, taken in addition to a regular diet for 4 months
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Dietary Supplement: Multivitamin and mineral supplements
Oral tablets taken daily
Dietary Supplement: Peptamen
Solution received daily
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2
Participants will receive NuBasics drinks or equivalent amounts of NuBasics soups or bars and daily multivitamin and mineral supplements, taken in addition to a regular diet for 4 months
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Dietary Supplement: Multivitamin and mineral supplements
Oral tablets taken daily
Dietary Supplement: NuBasics
Solution or dietary bar received daily
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3
Participants will receive multivitamin and mineral supplements, taken in addition to a regular diet for 4 months
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Dietary Supplement: Multivitamin and mineral supplements
Oral tablets taken daily
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Patients will be randomized to one of 3 study arms:
Arm 1 - Peptamen drinks + multivitamin and mineral supplement, taken in addition to regular diet for 4 months Arm 2 - NuBasics drinks or equivalent amounts of NuBasics soups or bars + multivitamin and mineral supplement, taken in addition to regular diet for 4 months Arm 3 - Multivitamin and mineral supplement, taken in addition to regular diet for 4 months.
At months 0, 2, and 4, patients will be assessed for weight, body cell mass, patient-reported physical activity level, and dietary intake (by 24-hour dietary recall). At months 2 and 4, they will also be assessed for compliance with study regimen. Patients who complete their 4 month follow up visit will be provided with a 30 day supply of the caloric supplement of their choice (Peptamen or NuBasics) and a 30 day supply of the study multivitamin supplement.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
HIV-infected participants who take a daily multivitamin and mineral supplement
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with any of the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
NOTE:
Patients with the following prior condition are excluded:
Prior Medication:
Excluded within the past 2 weeks:
Excluded within the past 30 days:
NOTE:
United States, California | |
Community Consortium / UCSF | |
San Francisco, California, United States, 94110 | |
United States, Colorado | |
Denver CPCRA / Denver Public Hlth | |
Denver, Colorado, United States, 802044507 | |
United States, District of Columbia | |
Washington Reg AIDS Prog / Dept of Infect Dis | |
Washington, District of Columbia, United States, 20422 | |
United States, Georgia | |
AIDS Research Consortium of Atlanta | |
Atlanta, Georgia, United States, 30308 | |
United States, Illinois | |
Rush Presbyterian - Saint Luke's Med Ctr | |
Chicago, Illinois, United States, 60612 | |
AIDS Research Alliance - Chicago | |
Chicago, Illinois, United States, 60657 | |
United States, Louisiana | |
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med | |
New Orleans, Louisiana, United States, 70112 | |
United States, Maryland | |
Baltimore Trials | |
Baltimore, Maryland, United States, 21201 | |
United States, Michigan | |
Henry Ford Hosp | |
Detroit, Michigan, United States, 48202 | |
Wayne State Univ / WSU / DMC HIV / AIDS Program | |
Detroit, Michigan, United States, 48201 | |
United States, New Jersey | |
North Jersey Community Research Initiative | |
Newark, New Jersey, United States, 071032842 | |
Southern New Jersey AIDS Cln Trials / Dept of Med | |
Camden, New Jersey, United States, 08103 | |
United States, New Mexico | |
Partners Research | |
Albuquerque, New Mexico, United States, 871315271 | |
Partners in Research - New Mexico | |
Albuquerque, New Mexico, United States, 87131 | |
United States, New York | |
Harlem AIDS Treatment Group / Harlem Hosp Ctr | |
New York, New York, United States, 10037 | |
United States, Oregon | |
Portland Veterans Adm Med Ctr / Rsch & Education Grp | |
Portland, Oregon, United States, 972109951 | |
United States, Pennsylvania | |
Philadelphia FIGHT | |
Philadelphia, Pennsylvania, United States, 19107 |
Study Chair: | Gilbert CL | |
Study Chair: | Wheeler D |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | CPCRA 038 |
Study First Received: | November 2, 1999 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00001077 |
Health Authority: | United States: Federal Government |
Weight Loss Acquired Immunodeficiency Syndrome Nutritional Support |
Sexually Transmitted Diseases, Viral Metabolic Diseases HIV Wasting Syndrome Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Body Weight Virus Diseases Signs and Symptoms |
HIV Infections Weight Loss Sexually Transmitted Diseases Body Weight Changes Nutrition Disorders Metabolic disorder Wasting Syndrome Retroviridae Infections |
RNA Virus Infections Pathologic Processes Disease Slow Virus Diseases |
Immune System Diseases Syndrome Lentivirus Infections Infection |