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
HIV Infections HIV Wasting Syndrome

Further Study Details: 

Expected Total Enrollment:  684

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 above,  Genders Eligible for Study:  Both

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.

California
      Community Consortium / UCSF, San Francisco,  California,  94110,  United States
Colorado
      Denver CPCRA / Denver Public Hlth, Denver,  Colorado,  802044507,  United States
District of Columbia
      Washington Reg AIDS Prog / Dept of Infect Dis, Washington,  District of Columbia,  20422,  United States
Georgia
      AIDS Research Consortium of Atlanta, Atlanta,  Georgia,  30308,  United States
Illinois
      Rush Presbyterian - Saint Luke's Med Ctr, Chicago,  Illinois,  60612,  United States
      AIDS Research Alliance - Chicago, Chicago,  Illinois,  60657,  United States
Louisiana
      Louisiana Comm AIDS Rsch Prog / Tulane Univ Med, New Orleans,  Louisiana,  70112,  United States
Maryland
      Baltimore Trials, Baltimore,  Maryland,  21201,  United States
Michigan
      Henry Ford Hosp, Detroit,  Michigan,  48202,  United States
      Wayne State Univ / WSU / DMC HIV / AIDS Program, Detroit,  Michigan,  48201,  United States
New Jersey
      North Jersey Community Research Initiative, Newark,  New Jersey,  071032842,  United States
      Southern New Jersey AIDS Cln Trials / Dept of Med, Camden,  New Jersey,  08103,  United States
New Mexico
      Partners Research, Albuquerque,  New Mexico,  871315271,  United States
      Partners in Research - New Mexico, Albuquerque,  New Mexico,  87131,  United States
New York
      Harlem AIDS Treatment Group / Harlem Hosp Ctr, New York,  New York,  10037,  United States
Oregon
      Portland Veterans Adm Med Ctr / Rsch & Education Grp, Portland,  Oregon,  972109951,  United States
Pennsylvania
      Philadelphia FIGHT, Philadelphia,  Pennsylvania,  19107,  United States

Study chairs or principal investigators

Gilbert CL,  Study Chair
Wheeler D,  Study Chair

Study ID Numbers:  CPCRA 038
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00001077
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08