HIV Infections, HIV Wasting Syndrome
Conditions
Keywords
Weight Loss, Acquired Immunodeficiency Syndrome, Nutritional Support
Brief 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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTMultivitamin and mineral supplements
Oral tablets taken daily
DIETARY_SUPPLEMENTPeptamen
Solution received daily
DIETARY_SUPPLEMENTNuBasics
Solution or dietary bar received daily
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed