Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001103
Status:
COMPLETED
Last Update Posted:
2008-07-29
First Post:
1999-11-02
Brief Title:
HIV Levels in Cerebrospinal Fluid and Brain Function in Patients Receiving Anti-HIV Drugs
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Cerebrospinal Fluid Human Immunodeficiency Virus-1 HIV-1 and Cognitive Function in Individuals Receiving Potent Antiretroviral Therapy
Status:
COMPLETED
Status Verified Date:
2006-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 060600 Patients already enrolled in an AACTG-sponsored study who are changing treatment due to virologic failure may also enter this study AS PER AMENDMENT 111501 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 060600 or before changing the antiretroviral regimen due to virologic failure in an ongoing trial AS PER AMENDMENT 111501 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 patients parent trial AS PER AMENDMENT 111501 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 111501 discontinues a potent antiretroviral therapy
Patients enrolling in one of several AACTG-sponsored potent antiretroviral therapy trials a parent trial may enter this study AS PER AMENDMENT 060600 Patients already enrolled in an AACTG-sponsored study who are changing treatment due to virologic failure may also enter this study AS PER AMENDMENT 111501 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 060600 or before changing the antiretroviral regimen due to virologic failure in an ongoing trial AS PER AMENDMENT 111501 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 patients parent trial AS PER AMENDMENT 111501 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 111501 discontinues a potent antiretroviral therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AACTG 736 | None | None | None |