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Ensayos clínicos

Ensayos clínicos

HIV Levels in Cerebrospinal Fluid and Brain Function in Patients Receiving Anti-HIV Drugs

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT00001103, ACTG 736
  • Concluido

Propósito del estudio

To compare the magnitude and durability of suppression of HIV-1 RNA in the plasma and cerebrospinal fluid (CSF) compartments in response to potent antiretroviral therapy. To determine if the magnitude and durability of the CSF HIV-1 RNA response to potent antiretroviral therapy is associated with improved performance on neuropsychological tests.

Afección:
Trastornos de Cognición
Infecciones por el VIH

Detalles del estudio

HIV-1 RNA emerges in CSF early in the course of HIV disease. Studies have shown that high levels of HIV-1 RNA in CSF correlate with increased severity of dementia and worsened performance on neuropsychological tests. While combination antiretroviral treatments are potent suppressors of HIV-1 replication in plasma, the extent to which these treatments suppress viral replication in CSF is unknown. A few studies suggest that antiretroviral treatments can reduce HIV-1 RNA in CSF. However, since CSF is isolated from peripheral immune responses to HIV and antiretroviral treatment may not readily penetrate the compartment, researchers hypothesize the remaining virus will overcome the antiretroviral treatment to achieve high levels of viral replication again. This virologic failure is likely accompanied by decreased cognitive function. It is therefore critical to determine the ability of antiretroviral treatments to control HIV-1 replication in the CSF and the durability of that viral suppression.Patients enrolling in 1 of several AACTG-sponsored potent antiretroviral therapy trials (a "parent" trial) may enter this study. [AS PER AMENDMENT 06/06/00: Patients already enrolled in an AACTG-sponsored study who are changing treatment due to virologic failure may also enter this study.] [AS PER AMENDMENT 11/15/01: Patients starting a new potent antiretroviral regimen as part of their clinical care, enrolling in a potent antiretroviral treatment trial, or changing potent antiretroviral therapy in clinical care or in an ongoing antiretroviral treatment trial because of virologic failure may enter this study.] Patients receive no treatment but undergo various procedures aimed at characterizing the effects of antiretroviral therapies on CSF viral load and cognitive function. Procedures include: 1) venipuncture to measure plasma HIV-1 RNA and DNA levels, CD4+ T cell count, and cytokine and immune activation markers associated with HIV-1 neurological disorders; 2) neuropsychological examinations to measure cognitive function; and 3) lumbar punctures to obtain CSF samples, which are used to determine the pharmacokinetics of antiretroviral agents in CSF and to determine levels of blood cells, cytokine and immune activation markers, and HIV-1 RNA and DNA. An entry visit must occur before initiating potent antiretroviral therapy in the parent trial [AS PER AMENDMENT 06/06/00: or before changing the antiretroviral regimen due to virologic failure in an ongoing trial]. [AS PER AMENDMENT 11/15/01: Patients are registered before initiating a new potent antiretroviral regimen.] Subsequent visits occur at 24 weeks, 12 months, and then annually. If evaluations, procedures, or assays for a given patient's parent trial [AS PER AMENDMENT 11/15/01: for any coenrollment AACTG study] occur at the times specified in this study, they are not duplicated for this study. Other visits may occur when a patient changes antiretroviral treatment or discontinues a parent trial [AS PER AMENDMENT 11/15/01: discontinues a potent antiretroviral therapy].

Criterios de exclusión

    Patients will not be eligible for this trial if they: Have an infection or cancer in the brain or certain diseases of the brain or nervous system. Have a serious psychiatric illness (such as schizophrenia or severe depression). Have completed treatment for a significant infection within 4 weeks of beginning the study (but certain drugs that fight infection are allowed on this study). Are taking drugs to prevent or dissolve blood clots. Abuse drugs or alcohol.

Centros de estudio/contactos

California

    Willow Clinic, Menlo Park, California, 94025, United States

    Univ of California / San Diego Treatment Ctr, San Diego, California, 921036325, United States

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

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

    San Mateo AIDS Program / Stanford Univ, Stanford, California, 943055107, United States

Colorado

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

Hawaii

    Univ of Hawaii, HonolulU, Hawaii, 96816-2396, United States

Illinois

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

Maryland

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

New York

    Columbia Presbyterian Med Ctr, New York, New York, 10032, 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

Ohio

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

    Case Western Reserve Univ, Cleveland, Ohio, 44106, United States

    MetroHealth Med Ctr, Cleveland, Ohio, 441091998, United States

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

Pennsylvania

    Univ of Pennsylvania at Philadelphia, Philadelphia, Pennsylvania, 19104, United States

    Univ of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States

Rhode Island

    Miriam Hosp / Brown Univ, Providence, Rhode Island, 02906, United States

South Carolina

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

Tennessee

    Comprehensive Care Clinic, Nashville, Tennessee, 37203, United States

Texas

    Univ of Texas, Southwestern Med Ctr of Dallas, Dallas, Texas, 75390, United States

Washington

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

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

Actualizado: 14 de octubre del 2004

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