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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000925 |
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.
Condition | Intervention | Phase |
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HIV Infections HIV Wasting Syndrome |
Drug: Optimune oral nutritional supplement |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Evaluation of High Protein Supplementation in HIV-1-Positive Subjects With Stable Weight Loss |
Estimated Enrollment: | 56 |
Study Start Date: | May 1999 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
You may be eligible for this study if you:
Exclusion Criteria
You will not be eligible for this study if you:
United States, California | |
San Francisco Gen Hosp | |
San Francisco, California, United States, 941102859 | |
Stanford Univ Med Ctr | |
Stanford, California, United States, 943055107 | |
UCLA CARE Ctr | |
Los Angeles, California, United States, 90095 | |
Univ of Southern California / LA County USC Med Ctr | |
Los Angeles, California, United States, 900331079 | |
United States, Colorado | |
Univ of Colorado Health Sciences Ctr | |
Denver, Colorado, United States, 80262 | |
United States, Hawaii | |
Queens Med Ctr | |
Honolulu, Hawaii, United States, 96816 | |
Univ of Hawaii | |
Honolulu, Hawaii, United States, 96816 | |
United States, Louisiana | |
Tulane Univ School of Medicine | |
New Orleans, Louisiana, United States, 70112 | |
United States, Maryland | |
Johns Hopkins Hosp | |
Baltimore, Maryland, United States, 21287 | |
United States, Missouri | |
St Louis Regional Hosp / St Louis Regional Med Ctr | |
St Louis, Missouri, United States, 63112 | |
United States, New York | |
Univ of Rochester Medical Center | |
Rochester, New York, United States, 14642 | |
Cornell Univ Med Ctr | |
New York, New York, United States, 10021 | |
Chelsea Ctr | |
New York, New York, United States, 10021 | |
United States, Ohio | |
Univ of Cincinnati | |
Cincinnati, Ohio, United States, 452670405 | |
Ohio State Univ Hosp Clinic | |
Columbus, Ohio, United States, 432101228 | |
United States, Pennsylvania | |
Philadelphia Veterans Administration Med Ctr | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, South Carolina | |
Julio Arroyo | |
West Columbia, South Carolina, United States, 29169 | |
United States, Washington | |
Univ of Washington | |
Seattle, Washington, United States, 98104 | |
Puerto Rico | |
Univ of Puerto Rico | |
San Juan, Puerto Rico, 009365067 |
Study Chair: | Kathleen Mulligan, MD | |
Study Chair: | Bruce R. Bistrian, MD | |
Study Chair: | Fred R. Sattler, MD |
Study ID Numbers: | ACTG 392 |
Study First Received: | November 2, 1999 |
Last Updated: | September 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00000925 |
Health Authority: | United States: Federal Government |
Dietary Proteins HIV Wasting Syndrome |
Sexually Transmitted Diseases, Viral Metabolic Diseases HIV Wasting Syndrome Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Body Weight Virus Diseases Signs and Symptoms HIV Seropositivity |
HIV Infections Weight Loss Sexually Transmitted Diseases Body Weight Changes Nutrition Disorders Metabolic disorder Wasting Syndrome Retroviridae Infections |
RNA Virus Infections Pathologic Processes Disease Slow Virus Diseases |
Immune System Diseases Syndrome Lentivirus Infections Infection |