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A Study to Evaluate High Protein Supplementation in HIV-Positive Patients with Stable Weight Loss Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about A Study to Evaluate High Protein Supplementation in HIV-Positive Patients with Stable Weight Loss conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Study to Evaluate High Protein Supplementation in HIV-Positive Patients with Stable Weight Loss Clinical research trials and A Study to Evaluate High Protein Supplementation in HIV-Positive Patients with Stable Weight Loss health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including A Study to Evaluate High Protein Supplementation in HIV-Positive Patients with Stable Weight Loss. A Study to Evaluate High Protein Supplementation in HIV-Positive Patients with Stable Weight Loss Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a A Study to Evaluate High Protein Supplementation in HIV-Positive Patients with Stable Weight Loss clinical trial. Test subjects typically receive the most expert healthcare available for their A Study to Evaluate High Protein Supplementation in HIV-Positive Patients with Stable Weight Loss condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Study to Evaluate High Protein Supplementation in HIV-Positive Patients with Stable Weight Loss  A Study to Evaluate High Protein Supplementation in HIV-Positive Patients with Stable Weight Loss
A Study to Evaluate High Protein Supplementation in HIV-Positive Patients with Stable Weight Loss
For Condition: HIV Infections,HIV Wasting Syndrome
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to determine whether a high-quality protein food supplement will help HIV-positive patients maintain, and possibly gain, muscle mass. Many HIV-positive patients lose weight that they are then unable to regain. This may be because patients are not eating enough protein or are not eating the right kinds of protein. The protein eaten in foods (such as meat, eggs, or beans) may not be able to make up for the amount of protein lost due to HIV infection. This study gives patients high-quality protein food supplements to help them maintain and/or gain weight.
Details: In many HIV-infected individuals with prior weight loss, the failure to regain weight and lean tissue is at least in part the consequence of inadequate protein intake or ingestion of a poor-quality protein rather than total caloric intake. Dietary sources of protein are presumably inadequate to meet the high metabolic needs caused by HIV infection. To achieve a target protein intake in the range (1.5 to 2.0 g/kg/day) demonstrated in other catabolic diseases necessary to achieve positive nitrogen balance and to generate substantial anabolic effects, this study will administer a supplement containing high-quality protein. Two groups of 28 patients each are randomly chosen to receive either an oral nutritional supplement (Optimune) containing increased amounts of high-quality protein (whey), which is rich in cysteine and glutamine, or an isocaloric, identical-tasting supplement without added whey protein or amino acid supplementation. Weight, body composition, anthropometry, dietary intake, and general physical health are assessed at baseline and at Weeks 6 and 12. Plasma cysteine, glutathione, C-reactive protein, and prealbumin, along with urine IL-6, sTNFrII, and IL-1ra, are assessed at baseline and at Week 12.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria You may be eligible for this study if you: - Are HIV-positive. - Are at least 18 years old. - Have an HIV level less than 5,000 copies/ml within 30 days of study entry. - Have lost weight in the past year, but your weight has remained fairly stable in the 2 months prior to enrollment. - Are expected to live for at least 6 months. - Are usually able to eat enough to maintain your present weight. - Are able to complete a 3-day food diary. Exclusion Criteria You will not be eligible for this study if you: - Have gained a significant amount of weight in the past 2 months. - Have any opportunistic (HIV-associated) infections. - Are unable to eat enough food for any reason, or are on tube feeding. - Have nausea, diarrhea, or vomiting in the 14 days prior to study entry. - Are being treated for diabetes. - Are receiving chemotherapy or radiation therapy to treat cancer. - Are pregnant or breast-feeding. - Are allergic to milk or mangoes. - Have an implanted defibrillator.
Total Enrollment: 56
Location and Contact Information:
Overall Study Official:
KathleenMulligan, Study Chair,
Univ of Washington
Seattle, Washington, 98104
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Chelsea Ctr
New York City, New York, 10021
United States
Queens Med Ctr
Honolulu, Hawaii, 96816
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Philadelphia Veterans Administration Med Ctr
Philadelphia, Pennsylvania, 19104
United States
Univ of Puerto Rico
San Juan, , 009365067
Puerto Rico
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis, Missouri, 63112
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Stanford Univ Med Ctr
Stanford, California, 943055107
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Additional Information:
Study ID Numbers: ACTG 392;
Study Start Date: May 1999
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000925
Other Hiv Wasting Syndrome Studies:
1. Nutrition Intervention in AIDS Wasting
2. A Phase II, Parallel Group, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Thalidomide in Reducing Weight Loss in Adults With HIV Wasting Syndrome
3. A Study to Evaluate the Effect of Nandrolone Decanoate in Women with HIV-Associated Weight Loss
4. A Study to Evaluate High Protein Supplementation in HIV-Positive Patients with Stable Weight Loss
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 Wasting Syndrome Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
A Study to Evaluate High Protein Supplementation in HIV-Positive Patients with Stable Weight Loss
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