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

Completed

Conditions studied: HIV Infections, HIV Wasting Syndrome

In brief

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.

Key facts

Study ID

NCT00001077

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

536

Starts

1996-06-01

Expected to finish

1998-04-01

Last updated by the study team

2013-10-01

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:

Where it is running

• Community Consortium / UCSF — San Francisco, California, United States
• Denver CPCRA / Denver Public Hlth — Denver, Colorado, United States
• Washington Reg AIDS Prog / Dept of Infect Dis — Washington D.C., District of Columbia, United States
• AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
• Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
• AIDS Research Alliance - Chicago — Chicago, Illinois, United States
• Louisiana Comm AIDS Rsch Prog / Tulane Univ Med — New Orleans, Louisiana, United States
• Baltimore Trials — Baltimore, Maryland, United States
• Wayne State Univ / WSU / DMC HIV / AIDS Program — Detroit, Michigan, United States
• Henry Ford Hosp — Detroit, Michigan, United States
• Southern New Jersey AIDS Cln Trials / Dept of Med — Camden, New Jersey, United States
• North Jersey Community Research Initiative — Newark, New Jersey, United States
• Partners in Research - New Mexico — Albuquerque, New Mexico, United States
• Partners Research — Albuquerque, New Mexico, United States
• Harlem AIDS Treatment Group / Harlem Hosp Ctr — New York, New York, United States
• Portland Veterans Adm Med Ctr / Rsch & Education Grp — Portland, Oregon, United States
• Philadelphia FIGHT — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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