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Ensayos clínicos

Ensayos clínicos

A Study to Evaluate the Use of Cidovir (an Experimental Drug) for the Treatment of Progressive Multifocal Leukoencephalopathy (PML) in AIDS Patients

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT00000945, ACTG 363
  • Concluido

Propósito del estudio

To evaluate the effect of cidofovir on the neurologic examination findings in HIV-1 associated progressive multifocal leukoencephalopathy (PML). To evaluate the safety and tolerability of cidofovir in the treatment of HIV-1 associated PML. To assess the effect of cidofovir on magnetic resonance-detected central nervous system lesions in HIV-1 associated PML. To assess the effect of cidofovir on the amount of JC virus DNA (JCV DNA) in the cerebrospinal fluid in HIV-1-associated PML. To assess the effect of cidofovir on the amount of JCV DNA in PBMCs in HIV-1-associated PML.

Afección:
Infecciones por el VIH
Leucoencefalopatía Progresiva Multifocal

Detalles del estudio

PML is a demyelinating disease of the brain's white matter, occurring when the JC virus infects the brain of patients infected with HIV-1. Cidofovir is known to be an effective treatment for cytomegalovirus of the eye and, in laboratory and animal testing, has also been shown to be effective against several other viruses. However, cidofovir is considered investigational as a treatment for PML.In this multicenter, open-label study 24 patients receive cidofovir iv over 1 hr on days 0, 7, then every 2 wk for a total of 13 doses. Oral probenecid is given 3h prior to and 2h and 8h following cidofovir administration. Nucleoside and non-nucleoside reverse transcriptors are withheld on days of probenecid administration. Protease inhibitors are continued during probenecid administration.

Criterios de exclusión

    You will not be eligible for this study if you: Have a history of uveitis. Are allergic to sulfa drugs or probenecid. Have had active opportunistic infections other than Kaposi's sarcoma within 30 days before study entry. Have sickle cell anemia or trait. Are pregnant or breast-feeding.

Centros de estudio/contactos

Alabama

    Univ of Alabama at Birmingham, Birmingham, Alabama, 35294, United States

California

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

    San Francisco AIDS Clinic / San Francisco Gen Hosp, San Francisco, California, 941102859, United States

Colorado

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

District of Columbia

    Howard Univ, Washington, District of Columbia, 20059, United States

Illinois

    Northwestern Univ Med School, Chicago, Illinois, 60611, United States

    Rush Presbyterian - Saint Luke's Med Ctr, Chicago, Illinois, 60612, United States

    Cook County Hosp, Chicago, Illinois, 60612, United States

    Louis A Weiss Memorial Hosp, Chicago, Illinois, 60640, United States

Maryland

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

New York

    SUNY / Erie County Med Ctr at Buffalo, Buffalo, New York, 14215, United States

    Bellevue Hosp / New York Univ Med Ctr, New York, New York, 10016, United States

    Mount Sinai Med Ctr, New York, New York, 10029, United States

    Beth Israel Med Ctr, New York, New York, 10003, United States

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

North Carolina

    Univ of North Carolina, Chapel Hill, North Carolina, 275997215, United States

Ohio

    Univ of Kentucky Lexington, Cincinnati, Ohio, 45267, United States

South Carolina

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

Washington

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

Actualizado: 13 de octubre del 2004

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