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Clinical Trial Name -A Study to Evaluate High Protein Supplementation in HIV-Positive Patients With Stable Weight Loss
| Original Study ID : ACTG 392 |
| NCT ID : NCT00000925 |
| Brief Title : A Study to Evaluate High Protein Supplementation in HIV-Positive Patients With Stable Weight Loss |
| Official Title : Evaluation of High Protein Supplementation in HIV-1-Positive Subjects With Stable Weight Loss |
| Brief Summary : 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. |
| Source : National Institute of Allergy and Infectious Diseases (NIAID) |
| Detailed Description : 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. |
| Overall Status : Completed |
| Start Date : May 1999 |
| Official Title : Phase 2 |
| Phase : Interventional |
| Study Design : Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Enrollment : 56 |
| Verification Date : June 2003 |
| First Received Date : November 2, 1999 |
| Trial Eligibility |
| 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. |
| Gender : Both |
| Minimum Age : 18 Years |
| Maximum Age : N/A |
| Healthy Volunteers : No |
| Facilities |
| Facility Name : San Francisco Gen Hosp |
| City : San Francisco |
| State : California |
| Zip Code : 941102859 |
| Country : United States |
| Facility Name : Stanford Univ Med Ctr |
| City : Stanford |
| State : California |
| Zip Code : 943055107 |
| Country : United States |
| Facility Name : UCLA CARE Ctr |
| City : Los Angeles |
| State : California |
| Zip Code : 90095 |
| Country : United States |
| Facility Name : Univ of Southern California / LA County USC Med Ctr |
| City : Los Angeles |
| State : California |
| Zip Code : 900331079 |
| Country : United States |
| Facility Name : Univ of Colorado Health Sciences Ctr |
| City : Denver |
| State : Colorado |
| Zip Code : 80262 |
| Country : United States |
| Facility Name : Queens Med Ctr |
| City : Honolulu |
| State : Hawaii |
| Zip Code : 96816 |
| Country : United States |
| Facility Name : Univ of Hawaii |
| City : Honolulu |
| State : Hawaii |
| Zip Code : 96816 |
| Country : United States |
| Facility Name : Tulane Univ School of Medicine |
| City : New Orleans |
| State : Louisiana |
| Zip Code : 70112 |
| Country : United States |
| Facility Name : Johns Hopkins Hosp |
| City : Baltimore |
| State : Maryland |
| Zip Code : 21287 |
| Country : United States |
| Facility Name : St Louis Regional Hosp / St Louis Regional Med Ctr |
| City : St Louis |
| State : Missouri |
| Zip Code : 63112 |
| Country : United States |
| Facility Name : Univ of Rochester Medical Center |
| City : Rochester |
| State : New York |
| Zip Code : 14642 |
| Country : United States |
| Facility Name : Cornell Univ Med Ctr |
| City : New York |
| State : New York |
| Zip Code : 10021 |
| Country : United States |
| Facility Name : Chelsea Ctr |
| City : New York |
| State : New York |
| Zip Code : 10021 |
| Country : United States |
| Facility Name : Univ of Cincinnati |
| City : Cincinnati |
| State : Ohio |
| Zip Code : 452670405 |
| Country : United States |
| Facility Name : Ohio State Univ Hosp Clinic |
| City : Columbus |
| State : Ohio |
| Zip Code : 432101228 |
| Country : United States |
| Facility Name : Philadelphia Veterans Administration Med Ctr |
| City : Philadelphia |
| State : Pennsylvania |
| Zip Code : 19104 |
| Country : United States |
| Facility Name : Julio Arroyo |
| City : West Columbia |
| State : South Carolina |
| Zip Code : 29169 |
| Country : United States |
| Facility Name : Univ of Washington |
| City : Seattle |
| State : Washington |
| Zip Code : 98104 |
| Country : United States |
| Facility Name : Univ of Puerto Rico |
| City : San Juan |
| State : Washington |
| Zip Code : 009365067 |
| Country : Puerto Rico |
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