Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027040
Status:
COMPLETED
Last Update Posted:
2015-01-16
First Post:
2001-11-16
Brief Title:
A Study of Decreased Mental Function Associated With HIV
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
HIV-Associated Cognitive Impairment and Oxidative Stress An In Vivo Proton Magnetic Resonance Spectroscopy Study of Cerebral Injury
Status:
COMPLETED
Status Verified Date:
2012-10
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 compare pictures of the brain of HIV-infected people with memory problems before and after treatment with selegiline Selegiline is the study drug received through A5090
HIV patients generally develop memory problems late in the disease This will be examined using noninvasive proton magnetic resonance spectroscopy 1H-MRS The effect of the drug selegiline on memory problems also will be examined
HIV patients generally develop memory problems late in the disease This will be examined using noninvasive proton magnetic resonance spectroscopy 1H-MRS The effect of the drug selegiline on memory problems also will be examined
Detailed Description:
HIV-associated cognitive impairment generally develops during the later stages of the disease This study proposes to non-invasively examine the pattern and extent of cerebral injury associated with HIV infection and its response to selegiline by using 1H-MRS The following hypotheses will be tested selegiline a compound with antioxidant and anti-apoptotic properties will reverse the metabolic abnormalities measured by 1H-MRS and these changes will parallel the degree of improvement in cognitive and functional performance
This is a substudy of ACTG A5090 The pattern and extent of cerebral injury associated with HIV infection and its response to selegiline are examined using a 1H-MRS 1H-MRS evaluations are performed at screening and Week 24 or at the time of premature discontinuation of Step 1 of A5090 The screening MRS exams may only be performed once all A5090 screening evaluations including the lumbar puncture have been completed and it has been determined that the patient is eligible for A5090 study entry
The screening MRS must be performed prior to A5090 study drug administration The Week-24 MRS must be performed while the patient is still on blinded study drug
This is a substudy of ACTG A5090 The pattern and extent of cerebral injury associated with HIV infection and its response to selegiline are examined using a 1H-MRS 1H-MRS evaluations are performed at screening and Week 24 or at the time of premature discontinuation of Step 1 of A5090 The screening MRS exams may only be performed once all A5090 screening evaluations including the lumbar puncture have been completed and it has been determined that the patient is eligible for A5090 study entry
The screening MRS must be performed prior to A5090 study drug administration The Week-24 MRS must be performed while the patient is still on blinded study drug
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ACTG A5114s | None | None | None |
| AACTG A5114s | None | None | None |