Status:
COMPLETED
A Comparison of Two Caloric Supplements in the Prevention of Weight Loss in Patients With AIDS Who Take Daily Multivitamin and Mineral Supplements
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
HIV Wasting Syndrome
Eligibility:
All Genders
13+ years
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 preven...
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...
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.
Key Trial Info
Start Date :
June 1 1996
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 1998
Estimated Enrollment :
536 Patients enrolled
Trial Details
Trial ID
NCT00001077
Start Date
June 1 1996
End Date
April 1 1998
Last Update
October 1 2013
Active Locations (17)
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1
Community Consortium / UCSF
San Francisco, California, United States, 94110
2
Denver CPCRA / Denver Public Hlth
Denver, Colorado, United States, 80204
3
Washington Reg AIDS Prog / Dept of Infect Dis
Washington D.C., District of Columbia, United States, 20422
4
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308