- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00001103
HIV Levels in Cerebrospinal Fluid and Brain Function in Patients Receiving Anti-HIV Drugs
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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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].
Studietype
Inschrijving
Contacten en locaties
Studie Locaties
-
-
-
San Juan, Puerto Rico, 009365067
- Univ of Puerto Rico
-
-
-
-
California
-
Menlo Park, California, Verenigde Staten, 94025
- Willow Clinic
-
San Diego, California, Verenigde Staten, 921036325
- Univ of California / San Diego Treatment Ctr
-
San Francisco, California, Verenigde Staten, 941102859
- San Francisco Gen Hosp
-
Stanford, California, Verenigde Staten, 943055107
- San Mateo AIDS Program / Stanford Univ
-
Stanford, California, Verenigde Staten, 943055107
- Stanford Univ Med Ctr
-
-
Colorado
-
Denver, Colorado, Verenigde Staten, 80262
- Univ of Colorado Health Sciences Ctr
-
-
Hawaii
-
HonolulU, Hawaii, Verenigde Staten, 96816-2396
- Univ of Hawaii
-
-
Illinois
-
Chicago, Illinois, Verenigde Staten, 60611
- Northwestern Univ Med School
-
-
Maryland
-
Baltimore, Maryland, Verenigde Staten, 21287
- Johns Hopkins Hosp
-
-
New York
-
New York, New York, Verenigde Staten, 10003
- Beth Israel Med Ctr
-
New York, New York, Verenigde Staten, 10016
- Bellevue Hosp / New York Univ Med Ctr
-
New York, New York, Verenigde Staten, 10029
- Mount Sinai Med Ctr
-
New York, New York, Verenigde Staten, 10032
- Columbia Presbyterian Med Ctr
-
Rochester, New York, Verenigde Staten, 14642
- Univ of Rochester Medical Center
-
-
Ohio
-
Cincinnati, Ohio, Verenigde Staten, 452670405
- Univ of Cincinnati
-
Cleveland, Ohio, Verenigde Staten, 44106
- Case Western Reserve Univ
-
Cleveland, Ohio, Verenigde Staten, 441091998
- MetroHealth Med Ctr
-
Columbus, Ohio, Verenigde Staten, 432101228
- Ohio State Univ Hosp Clinic
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Verenigde Staten, 19104
- Univ of Pennsylvania at Philadelphia
-
Pittsburgh, Pennsylvania, Verenigde Staten, 15213
- Univ of Pittsburgh
-
-
Rhode Island
-
Providence, Rhode Island, Verenigde Staten, 02906
- Miriam Hosp / Brown Univ
-
-
South Carolina
-
West Columbia, South Carolina, Verenigde Staten, 29169
- Julio Arroyo
-
-
Tennessee
-
Nashville, Tennessee, Verenigde Staten, 37203
- Comprehensive Care Clinic
-
-
Texas
-
Dallas, Texas, Verenigde Staten, 75390
- Univ of Texas, Southwestern Med Ctr of Dallas
-
-
Washington
-
Seattle, Washington, Verenigde Staten, 98104
- Univ of Washington
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Studie stoel: Christina Marra, MD, University of Washington
- Studie stoel: Kevin Robertson, PhD, University of North Carolina, Chapel Hill
Studie record data
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- ACTG 736
- AACTG 736
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op HIV-infecties
-
University of Alabama at BirminghamMobile County Health Deparment; Alabama Department of Public HealthWervingHiv | HIV-testen | Hiv-koppeling naar zorg | HIV-behandelingVerenigde Staten
-
ANRS, Emerging Infectious DiseasesHopital Universitaire Robert-Debre; Institut de Recherche pour le Developpement; Centre Pasteur du Cameroun en andere medewerkersOnbekendHiv | HIV-niet-geïnfecteerde kinderen | Kinderen blootgesteld aan HIVKameroen
-
French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS FoundationVoltooidPartner hiv-testen | HIV-counseling voor koppels | Paar communicatie | HIV-incidentieKameroen, Dominicaanse Republiek, Georgië, Indië
-
University of MinnesotaIngetrokkenHIV-infecties | Hiv/aids | Hiv | AIDS | Aids/Hiv probleem | AIDS en infectiesVerenigde Staten
-
Erasmus Medical CenterNog niet aan het wervenHIV-infecties | Hiv | HIV-1-infectie | HIV I-infectieNederland
-
University of Maryland, BaltimoreIngetrokkenHiv | Niertransplantatie | HIV-reservoir | CCR5Verenigde Staten
-
Africa Health Research InstituteLondon School of Hygiene and Tropical Medicine; University College, London; University... en andere medewerkersWervingHiv | HIV-testen | Koppeling aan zorgZuid-Afrika
-
Hospital Clinic of BarcelonaVoltooidIntegrase-remmers, HIV; HIV PROTEASE INHIBSpanje
-
National Taiwan UniversityWerving
-
Helios SaludViiV HealthcareOnbekendHiv | HIV-1-infectieArgentinië