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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Page 1 of 5 (17 locations)

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