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A Comparison of Two Caloric Supplements in the Prevention of Weight Loss in Patients with AIDS Who Take Daily Multivitamin and Mineral Supplements Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about A Comparison of Two Caloric Supplements in the Prevention of Weight Loss in Patients with AIDS Who Take Daily Multivitamin and Mineral Supplements conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Comparison of Two Caloric Supplements in the Prevention of Weight Loss in Patients with AIDS Who Take Daily Multivitamin and Mineral Supplements Clinical research trials and A Comparison of Two Caloric Supplements in the Prevention of Weight Loss in Patients with AIDS Who Take Daily Multivitamin and Mineral Supplements medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as A Comparison of Two Caloric Supplements in the Prevention of Weight Loss in Patients with AIDS Who Take Daily Multivitamin and Mineral Supplements. A Comparison of Two Caloric Supplements in the Prevention of Weight Loss in Patients with AIDS Who Take Daily Multivitamin and Mineral Supplements Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a A Comparison of Two Caloric Supplements in the Prevention of Weight Loss in Patients with AIDS Who Take Daily Multivitamin and Mineral Supplements clinical trial. Participants frequently get the best healthcare available for their A Comparison of Two Caloric Supplements in the Prevention of Weight Loss in Patients with AIDS Who Take Daily Multivitamin and Mineral Supplements condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Comparison of Two Caloric Supplements in the Prevention of Weight Loss in Patients with AIDS Who Take Daily Multivitamin and Mineral Supplements  A Comparison of Two Caloric Supplements in the Prevention of Weight Loss in Patients with AIDS Who Take Daily Multivitamin and Mineral Supplements
A Comparison of Two Caloric Supplements in the Prevention of Weight Loss in Patients with AIDS Who Take Daily Multivitamin and Mineral Supplements
For Condition: HIV Infections,HIV Wasting Syndrome
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 684
Location and Contact Information:
Overall Study Official:
GilbertCL, Study Chair,
Wayne State Univ / WSU / DMC HIV / AIDS Program
Detroit, Michigan, 48201
United States
Partners in Research - New Mexico
Albuquerque, New Mexico, 87131
United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, 70112
United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107
United States
Washington Reg AIDS Prog / Dept of Infect Dis
Washington D.C., District of Columbia, 20422
United States
Henry Ford Hosp
Detroit, Michigan, 48202
United States
Partners Research
Albuquerque, New Mexico, 871315271
United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 972109951
United States
Baltimore Trials
Baltimore, Maryland, 21201
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Denver CPCRA / Denver Public Hlth
Denver, Colorado, 802044507
United States
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657
United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
United States
North Jersey Community Research Initiative
Newark, New Jersey, 071032842
United States
Community Consortium / UCSF
San Francisco, California, 94110
United States
Southern New Jersey AIDS Cln Trials / Dept of Med
Camden, New Jersey, 08103
United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York City, New York, 10037
United States
Additional Information:
Study ID Numbers: CPCRA 038;
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001077
Other Hiv Infections Studies:
1. A Study of Didanosine Use Alone or in Combination with Zidovudine in Infants Exposed to or Infected with HIV
2. The Safety and Effectiveness of RMP-7 Plus Amphotericin B in Patients with HIV and Cryptococcal Meningitis
3. A Pilot Open Label Trial of HIV Therapy with d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects with Recent HIV Infection
4. A Study to Evaluate Various Combinations of Anti-HIV Medications to Treat Early HIV Infection
5. A Randomized, Controlled, Multicenter Trial of Filgrastim (Recombinant-methionyl Human Granulocyte Colony Stimulating Factor; G-CSF) for the Prevention of Grade 4 Neutropenia in Patients With HIV Infection.
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A Comparison of Two Caloric Supplements in the Prevention of Weight Loss in Patients with AIDS Who Take Daily Multivitamin and Mineral Supplements
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