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| Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00001077 |
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 |
|
HIV Infections HIV Wasting Syndrome |
| MedlinePlus related topics: | AIDS Dietary Supplements Minerals Weight Control |
| Study Type: | Observational |
| Study Design: | Natural History |
| 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 |
| Estimated Enrollment: | 684 |
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 |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with any of the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
NOTE:
Patients with the following prior condition are excluded:
Prior Medication:
Excluded within the past 2 weeks:
Excluded within the past 30 days:
NOTE:
Contacts and 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, 802044507 | |||||
| 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 | |||||
| North Jersey Community Research Initiative | |||||
| Newark, New Jersey, United States, 071032842 | |||||
| Southern New Jersey AIDS Cln Trials / Dept of Med | |||||
| Camden, New Jersey, United States, 08103 | |||||
| United States, New Mexico | |||||
| Partners Research | |||||
| Albuquerque, New Mexico, United States, 871315271 | |||||
| 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, 972109951 | |||||
| United States, Pennsylvania | |||||
| Philadelphia FIGHT | |||||
| Philadelphia, Pennsylvania, United States, 19107 | |||||
| Study Chair: | Gilbert CL | |
| Study Chair: | Wheeler D |
More Information
| 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. Review.
  |
| 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.
  |
| Study ID Numbers: | CPCRA 038 |
| First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00001077 |
| Health Authority: | United States: Federal Government |
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