a comparison of two caloric supplements in the prevention of weight loss in patients with aids who take daily multivitamin and mineral supplements

Conditions: HIV Infections; HIV Wasting Syndrome

Summary: 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.

Eligibility criteria:
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.

Keywords: weight loss acquired immunodeficiency syndrome nutritional support