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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00001077
First received: November 2, 1999
Last updated: September 28, 2013
Last verified: September 2013
  Purpose

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 Intervention
HIV Infections
HIV Wasting Syndrome
Dietary Supplement: Multivitamin and mineral supplements
Dietary Supplement: Peptamen
Dietary Supplement: NuBasics

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Open-Label, Randomized, Three-Arm, Comparative Trial of a Caloric Supplement With Peptides and Medium-Chain Triglycerides Versus a Caloric Supplement With Whole Protein and Long-Chain Triglycerides Versus No Caloric Supplement for the Prevention of Weight Loss in Individuals With AIDS Who Take a Daily Multivitamin and Mineral Supplement

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Biospecimen Retention:   Samples With DNA

Blood collection


Enrollment: 536
Study Start Date: June 1996
Study Completion Date: April 1998
Primary Completion Date: April 1998 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Participants will receive peptamen drinks and multivitamin and mineral supplements, taken in addition to a regular diet for 4 months
Dietary Supplement: Multivitamin and mineral supplements
Oral tablets taken daily
Dietary Supplement: Peptamen
Solution received daily
2
Participants will receive NuBasics drinks or equivalent amounts of NuBasics soups or bars and daily multivitamin and mineral supplements, taken in addition to a regular diet for 4 months
Dietary Supplement: Multivitamin and mineral supplements
Oral tablets taken daily
Dietary Supplement: NuBasics
Solution or dietary bar received daily
3
Participants will receive multivitamin and mineral supplements, taken in addition to a regular diet for 4 months
Dietary Supplement: Multivitamin and mineral supplements
Oral tablets taken daily

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 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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

HIV-infected participants who take a daily multivitamin and mineral supplement

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001077

Locations
United States, California
Community Consortium / UCSF
San Francisco, California, United States, 94110
United States, Colorado
Denver CPCRA / Denver Public Hlth
Denver, Colorado, United States, 80204
United States, District of Columbia
Washington Reg AIDS Prog / Dept of Infect Dis
Washington, District of Columbia, United States, 20422
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
United States, Illinois
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
AIDS Research Alliance - Chicago
Chicago, Illinois, United States, 60657
United States, Louisiana
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, United States, 70112
United States, Maryland
Baltimore Trials
Baltimore, Maryland, United States, 21201
United States, Michigan
Henry Ford Hosp
Detroit, Michigan, United States, 48202
Wayne State Univ / WSU / DMC HIV / AIDS Program
Detroit, Michigan, United States, 48201
United States, New Jersey
Southern New Jersey AIDS Cln Trials / Dept of Med
Camden, New Jersey, United States, 08103
North Jersey Community Research Initiative
Newark, New Jersey, United States, 07103
United States, New Mexico
Partners Research
Albuquerque, New Mexico, United States, 87131
Partners in Research - New Mexico
Albuquerque, New Mexico, United States, 87131
United States, New York
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, United States, 10037
United States, Oregon
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, United States, 97210
United States, Pennsylvania
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Investigators
Study Chair: Gilbert CL
Study Chair: Wheeler D
  More Information

Publications:
Gibert CL, Muurahainen N, Collins G, Williams B, Raghavan S, Bartsch G, Wheeler D. Body composition in HIV-infected men and women in 1996-1997 (CPCRA 038). Int Conf AIDS. 1998;12:554 (abstract no 32169)
Williams SB, Collins G, Muurahainen N, Bartsch G, Gibert C, Raghavan SS, Wheeler D. Protein intake is associated with body cell mass in weight-stable HIV+ men with CD4 < 200 cells/mm3: CPCRA 038. Int Conf AIDS. 1998;12:841-2 (abstract no 42339)
Muurahainen N, Collins G, Wheeler D, Mateo N, Madans M, Bartsch G, Gilbert C. Body cell mass (BCM) in HIV-infected (HIV+) males in the community programs for clinical research on AIDS (CPCRA) in 1996-1997. Int Conf AIDS. 1998;12:840 (abstract no 42333)

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00001077     History of Changes
Other Study ID Numbers: CPCRA 038, 11588
Study First Received: November 2, 1999
Last Updated: September 28, 2013
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Weight Loss
Acquired Immunodeficiency Syndrome
Nutritional Support

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Wasting Syndrome
Weight Loss
HIV Wasting Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Metabolic Diseases
Nutrition Disorders
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 21, 2014