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Ensayos clínicos

Ensayos clínicos

The Effect of Anti-HIV Therapy on Fat Metabolism in HIV-Positive Patients

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT00001102, CPCRA 061
  • Concluido

Propósito del estudio

The purpose of this study is to compare the randomized HAART strategy groups in the FIRST (Flexible Initial Retrovirus Suppressive Therapies) protocol (CPCRA 058) for changes in total cholesterol, triglycerides, waist circumference, and waist-to-hip ratio. The randomized HAART strategies in the FIRST study are (1) a protease inhibitor (PI)-containing regimen, (2) a nonnucleoside reverse transcriptase (NNRTI)-containing regimen, and (3) a combination PI- and NNRTI-containing regimen. Background nucleoside reverse transcriptase inhibitor (NRTI) therapy is included in each regimen.

Afección:
Infecciones por el VIH

Detalles del estudio

Close to 3 years into widespread PI use, several toxicities, including metabolic alterations, are being reported increasingly in conjunction with the use of PI-containing regimens. Some of the manifestations of these metabolic alterations include hyper/dyslipidemia, hyperglycemia, insulin resistance and glucose intolerance, lipodystrophy (in face and extremities), and body fat redistribution (e.g., central obesity and buffalo humps). Despite reports of increasing prevalence of metabolic complications among PI users, the question of whether they result from PI therapy has not been answered. Some of these complications, e.g., a decrease in peripheral fat with an increase in visceral fat and buffalo hump, have been observed in HIV-infected individuals who were not receiving PIs. This study compares 3 different antiretroviral regimens used in the FIRST study (CPCRA 058), 1 of which does not contain a PI, and examines metabolic alterations which occur.This study enrolls patients simultaneously co-enrolling in the FIRST protocol; 120 patients from each of the FIRST study strategy groups. At entry, Months 1 and 4, and then every 4 months, blood is drawn to measure serum glucose, insulin, total cholesterol, HDL cholesterol, LDL cholesterol, and triglyceride levels. At entry and Months 4, 8, 12, and then every 12 months, body cell mass, and body fat by bioelectrical impedance analysis (BIA) are assessed. [AS PER AMENDMENT 7/5/01: At Months 4, 8, and 12, then every 4 months through closure of the FIRST protocol] patients are weighed and skinfold measurements and body circumference measurements are done. Statistical evaluations are performed on the data.

Centros de estudio/contactos

California

    Community Consortium / UCSF, San Francisco, California, 94110, United States

Colorado

    Denver CPCRA / Denver Public Hlth, Denver, Colorado, 802044507, United States

District of Columbia

    Washington Reg AIDS Prog / Dept of Infect Dis, Washington, District of Columbia, 20422, United States

Georgia

    AIDS Research Consortium of Atlanta, Atlanta, Georgia, 303081962, United States

Illinois

    AIDS Research Alliance - Chicago, Chicago, Illinois, 60657, United States

Louisiana

    Louisiana Comm AIDS Rsch Prog / Tulane Univ Med, New Orleans, Louisiana, 70112, United States

Michigan

    Henry Ford Hosp, Detroit, Michigan, 48202, United States

    Wayne State Univ - WSU/DMC / Univ Hlth Ctr, Detroit, Michigan, 48201, United States

New Jersey

    Southern New Jersey AIDS Cln Trials / Dept of Med, Camden, New Jersey, 08103, United States

    North Jersey Community Research Initiative, Newark, New Jersey, 071032842, United States

New Mexico

    Partners in Research / New Mexico, Albuquerque, New Mexico, 87131, United States

New York

    Harlem AIDS Treatment Grp / Harlem Hosp Ctr, New York, New York, 10037, United States

Oregon

    The Research and Education Group, Portland, Oregon, 97210, United States

Pennsylvania

    Philadelphia FIGHT, Philadelphia, Pennsylvania, 19107, United States

Virginia

    Richmond AIDS Consortium / Div of Infect Diseases, Richmond, Virginia, 232980049, United States

Actualizado: 13 de octubre del 2004

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