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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 Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult 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 dedicated 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 health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like 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 volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes 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. Human subjects often 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. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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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 to Evaluate High Protein Supplementation in HIV-Positive Patients with Stable Weight Loss
2. A Study to Evaluate the Effect of Nandrolone Decanoate in Women with HIV-Associated Weight Loss
3. Nutrition Intervention in AIDS Wasting
4. Compassionate Use Study of Two Dose Levels of Thalidomide in Adults With HIV Wasting Syndrome
5. A Study of Megestrol Acetate Alone or in Combination with Testosterone Enanthate Drug in the Treatment of HIV-Associated Weight Loss
Related Studies:
Other HIV Infections Clinical Trials
Other Louisiana Clinical Trials
Other New Orleans Clinical Trials
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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