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

28 luglio 2008 aggiornato da: National Institute of Allergy and Infectious Diseases (NIAID)

Cerebrospinal Fluid Human Immunodeficiency Virus-1 (HIV-1) and Cognitive Function in Individuals Receiving Potent Antiretroviral Therapy

The purpose of this study is to see whether anti-HIV drugs that reduce HIV in the blood also reduce HIV in the cerebrospinal fluid (CSF). CSF is the fluid found around the brain and spinal cord. This study also looks at whether reducing HIV in the CSF can help protect brain function.

HIV can be detected in the brain and CSF early in HIV disease. Anti-HIV drugs probably reduce HIV in the CSF. This may be important because other studies have suggested high CSF HIV levels may lead to some loss of brain function.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

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 one 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 within 21 days prior to each lumbar puncture and at Weeks 24 and 52. 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].

Tipo di studio

Osservativo

Iscrizione

100

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Porto Rico
      • San Juan, Porto Rico, 009365067
        • Univ of Puerto Rico
  • Stati Uniti
    • California
      • Menlo Park, California, Stati Uniti, 94025
        • Willow Clinic
      • San Diego, California, Stati Uniti, 921036325
        • Univ of California / San Diego Treatment Ctr
      • San Francisco, California, Stati Uniti, 941102859
        • San Francisco Gen Hosp
      • Stanford, California, Stati Uniti, 943055107
        • San Mateo AIDS Program / Stanford Univ
      • Stanford, California, Stati Uniti, 943055107
        • Stanford Univ Med Ctr
    • Colorado
      • Denver, Colorado, Stati Uniti, 80262
        • Univ of Colorado Health Sciences Ctr
    • Hawaii
      • HonolulU, Hawaii, Stati Uniti, 96816-2396
        • Univ of Hawaii
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60611
        • Northwestern Univ Med School
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21287
        • Johns Hopkins Hosp
    • New York
      • New York, New York, Stati Uniti, 10003
        • Beth Israel Med Ctr
      • New York, New York, Stati Uniti, 10016
        • Bellevue Hosp / New York Univ Med Ctr
      • New York, New York, Stati Uniti, 10029
        • Mount Sinai Med Ctr
      • New York, New York, Stati Uniti, 10032
        • Columbia Presbyterian Med Ctr
      • Rochester, New York, Stati Uniti, 14642
        • Univ of Rochester Medical Center
    • Ohio
      • Cincinnati, Ohio, Stati Uniti, 452670405
        • Univ of Cincinnati
      • Cleveland, Ohio, Stati Uniti, 44106
        • Case Western Reserve Univ
      • Cleveland, Ohio, Stati Uniti, 441091998
        • MetroHealth Med Ctr
      • Columbus, Ohio, Stati Uniti, 432101228
        • Ohio State Univ Hosp Clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19104
        • Univ of Pennsylvania at Philadelphia
      • Pittsburgh, Pennsylvania, Stati Uniti, 15213
        • Univ of Pittsburgh
    • Rhode Island
      • Providence, Rhode Island, Stati Uniti, 02906
        • Miriam Hosp / Brown Univ
    • South Carolina
      • West Columbia, South Carolina, Stati Uniti, 29169
        • Julio Arroyo
    • Tennessee
      • Nashville, Tennessee, Stati Uniti, 37203
        • Comprehensive Care Clinic
    • Texas
      • Dallas, Texas, Stati Uniti, 75390
        • Univ of Texas, Southwestern Med Ctr of Dallas
    • Washington
      • Seattle, Washington, Stati Uniti, 98104
        • Univ of Washington

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria

  • Are HIV-positive.
  • Have levels of CD4 cells (immune cells that fight infection) less than 200 cells/mm3 and viral loads (level of HIV in the blood) greater than 2,000 copies/ml or viral loads greater than 50,000 copies/ml and any CD4 cell levels.
  • Are either: 1) starting a new potent antiretroviral therapy for HIV; 2) enrolling in a potent antiretroviral trial; or 3) currently participating in an ongoing antiretroviral trial or in clinical care and will be changing treatment due to treatment failure. The entry visit for ACTG 736 must occur before starting the treatment or before changing to the new treatment. (This study has been changed to include patients who have changed treatment due to treatment failure and those who are starting a new anti-HIV regimen.)

Exclusion Criteria

  • 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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaboratori

National Institute of Neurological Disorders and Stroke (NINDS)
Neurologic AIDS Research Consortium (NARC)

Investigatori

  • Cattedra di studio: Christina Marra, MD, University of Washington
  • Cattedra di studio: Kevin Robertson, PhD, University of North Carolina, Chapel Hill

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Date di iscrizione allo studio

Primo inviato

2 novembre 1999

Primo inviato che soddisfa i criteri di controllo qualità

30 agosto 2001

Primo Inserito (Stima)

31 agosto 2001

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

29 luglio 2008

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 luglio 2008

Ultimo verificato

1 maggio 2006

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ACTG 736
  • AACTG 736

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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