A Comparison of Two Caloric Supplements in the Prevention of Weight Loss in Patients With AIDS Who Take Daily Multivitamin and Mineral Supplements
NCT ID: NCT00001077
Last Updated: 2013-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
536 participants
OBSERVATIONAL
1996-06-30
1998-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1
Participants will receive peptamen drinks and multivitamin and mineral supplements, taken in addition to a regular diet for 4 months
Multivitamin and mineral supplements
Oral tablets taken daily
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
Multivitamin and mineral supplements
Oral tablets taken daily
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
Multivitamin and mineral supplements
Oral tablets taken daily
Interventions
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Multivitamin and mineral supplements
Oral tablets taken daily
Peptamen
Solution received daily
NuBasics
Solution or dietary bar received daily
Eligibility Criteria
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Inclusion Criteria
* 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
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.
13 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Gilbert CL
Role: STUDY_CHAIR
Wheeler D
Role: STUDY_CHAIR
Locations
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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
Countries
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References
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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, Mulligan K. Clinical trials update in human immunodeficiency virus wasting. Semin Oncol. 1998 Apr;25(2 Suppl 6):104-11.
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)
Gibert CL, Wheeler DA, Collins G, Madans M, Muurahainen N, Raghavan SS, Bartsch G. Randomized, controlled trial of caloric supplements in HIV infection. Terry Beirn Community Programs for Clinical Research on AIDS. J Acquir Immune Defic Syndr. 1999 Nov 1;22(3):253-9. doi: 10.1097/00126334-199911010-00006.
Other Identifiers
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11588
Identifier Type: REGISTRY
Identifier Source: secondary_id
CPCRA 038
Identifier Type: -
Identifier Source: org_study_id