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

28. juli 2008 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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].

Undersøgelsestype

Observationel

Tilmelding

100

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Barn
Voksen
Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Samarbejdspartnere

National Institute of Neurological Disorders and Stroke (NINDS)

Neurologic AIDS Research Consortium (NARC)

Efterforskere

Studiestol: Christina Marra, MD, University of Washington
Studiestol: Kevin Robertson, PhD, University of North Carolina, Chapel Hill

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Datoer for studieregistrering

Først indsendt

2. november 1999

Først indsendt, der opfyldte QC-kriterier

30. august 2001

Først opslået (Skøn)

31. august 2001

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. juli 2008

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. juli 2008

Sidst verificeret

1. maj 2006

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

ACTG 736
AACTG 736

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .