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Ensayos clínicos

Ensayos clínicos

A Study to Evaluate High Protein Supplementation in HIV-Positive Patients with Stable Weight Loss

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT00000925, ACTG 392
  • Concluido

Propósito del estudio

To determine whether use of a conventional oral supplement containing increased amounts of high biologic quality protein (whey), which is rich in cysteine and glutamine, results in better repletion and maintenance of lean tissue than an isocaloric supplement without whey protein or amino acid supplementation.

Afección:Fase:
Infecciones por el VIH
Síndrome de Emaciación causado por el VIH
Fase 2

Detalles del estudio

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.

Criterios de exclusión

    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.

Centros de estudio/contactos

California

    UCLA CARE Ctr, Los Angeles, California, 90095, United States

    Univ of Southern California / LA County USC Med Ctr, Los Angeles, California, 900331079, United States

    San Francisco Gen Hosp, San Francisco, California, 941102859, United States

    Stanford Univ Med Ctr, Stanford, California, 943055107, United States

Colorado

    Univ of Colorado Health Sciences Ctr, Denver, Colorado, 80262, United States

Hawaii

    Queens Med Ctr, Honolulu, Hawaii, 96816, United States

    Univ of Hawaii, Honolulu, Hawaii, 96816, United States

Louisiana

    Tulane Univ School of Medicine, New Orleans, Louisiana, 70112, United States

Maryland

    Johns Hopkins Hosp, Baltimore, Maryland, 21287, United States

Missouri

    St Louis Regional Hosp / St Louis Regional Med Ctr, St Louis, Missouri, 63112, United States

New York

    Cornell Univ Med Ctr, New York, New York, 10021, United States

    Chelsea Ctr, New York, New York, 10021, United States

    Univ of Rochester Medical Center, Rochester, New York, 14642, United States

Ohio

    Univ of Cincinnati, Cincinnati, Ohio, 452670405, United States

    Ohio State Univ Hosp Clinic, Columbus, Ohio, 432101228, United States

Pennsylvania

    Philadelphia Veterans Administration Med Ctr, Philadelphia, Pennsylvania, 19104, United States

South Carolina

    Julio Arroyo, West Columbia, South Carolina, 29169, United States

Washington

    Univ of Washington, Seattle, Washington, 98104, United States

    Univ of Puerto Rico, San Juan, Washington, 009365067, Puerto Rico

Actualizado: 13 de octubre del 2004

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