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