A Comparison of Two Caloric Supplements in the Prevention of Weight Loss in Patients With AIDS Who Take Daily Multivitamin and Mineral Supplements

National Institute of Allergy and Infectious Diseases (NIAID)536 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

536

Conditions

HIV Infections HIV Wasting Syndrome

Interventions

Multivitamin and mineral supplementsDIETARY_SUPPLEMENT

Oral tablets taken daily

PeptamenDIETARY_SUPPLEMENT

Solution received daily

NuBasicsDIETARY_SUPPLEMENT

Solution or dietary bar received daily

Eligibility

Sex: ALLMin age: 13 Years

Medical Language ↔ Plain English

Inclusion Criteria Patients must have: * HIV infection. * Stable weight. * CD4+ cell count \<200 cells/mm3. * Life expectancy of at least 6 months. * Parent or legal guardian to sign written, informed consent for patients \< 18 years old. Exclusion Criteria Co-existing Condition: Patients with any of the following symptoms or conditions are excluded: * Active opportunistic infection, requiring acute treatment. * Malignancy (other than stable cutaneous Kaposi's sarcoma that does not require systemic chemotherapy). * Diabetes mellitus or other conditions requiring special dietary restrictions. * Body mass index (BMI) \>= 29.0 kg/m2. * Disorders or conditions that, in the treating clinician's opinion, may prevent adequate compliance with protocol requirements. Concurrent Medication: Excluded: * Growth hormone. * Megestrol acetate (Megace). * Cyproheptadine (Periactin). * Dronabinol (Marinol). * Thalidomide. * Anabolic steroids (e.g., nandrolone decanoate)(Deca-durabolin). * Pharmacologic-dose corticosteroids (e.g., \> 15 mg/day prednisone equivalent) NOTE: * Men requiring testosterone replacement therapy for documented hypogonadism may be enrolled. * Caloric nutritional supplements deemed by the clinician to promote weight gain or maintenance. Patients with the following prior condition are excluded: * History of phenylketonuria. Prior Medication: Excluded within the past 2 weeks: * Use of caloric nutritional supplements for more than 5 days deemed by the clinician to promote weight gain or maintenance. Excluded within the past 30 days: * Growth hormone. * Megestrol acetate (Megace). * Cyproheptadine (Periactin). * Dronabinol (Marinol). * Thalidomide. * Anabolic steroids (e.g., nandrolone decanoate)(Deca-durabolin) * Pharmacologic-dose corticosteroids (e.g., \> 15 mg/day prednisone equivalent). NOTE: * Men requiring testosterone replacement therapy for documented hypogonadism may be enrolled.

Locations (17)

Community Consortium / UCSF

San Francisco, California, United States

Denver CPCRA / Denver Public Hlth

Denver, Colorado, United States

Data from ClinicalTrials.gov

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