Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2026-03-05 @ 12:18 AM
Study NCT ID:
NCT00864292
Status:
COMPLETED
Last Update Posted:
2011-05-03
First Post:
2009-03-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictors of Neuro-cognitive Decline and Survival in HIV-infected Subjects
Sponsor:
SEARCH Research Foundation
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2009-03
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:
Patients will be followed every 6 months for a total of 5 visits (Month 0, 6, 12, 18 and 24). The first visit is the screening and entry visit which can occur at any time after the subject finishes SEARCH 001 study but preferably it should occur approximately 6 months after SEARCH 001 study completion.
At each visit, patients will undergo the following
1. Assessment of function including activity of daily living questionnaire
2. History of medical illnesses, medication history
3. Neurological examination: All patients will have a neurological evaluation and neuropsychological evaluation to characterize neurocognitive and neurological status. (It is possible that patients within the non-dementia group will meet criteria for dementia after close testing is completed).
4. Neuropsychological assessment:
5. Thai Depression Inventory.
6. HIV viral load and storage of blood for proviral DNA level
Final outcome assessment based on all available data. If possible, it is intended that these diagnoses will be determined through monthly VTC conference calls with UH investigators. This consensus conference will include the Thai investigators, the UH neurologist, the UH neuropsychologist and the UH principal investigators.
At each visit, patients will undergo the following
1. Assessment of function including activity of daily living questionnaire
2. History of medical illnesses, medication history
3. Neurological examination: All patients will have a neurological evaluation and neuropsychological evaluation to characterize neurocognitive and neurological status. (It is possible that patients within the non-dementia group will meet criteria for dementia after close testing is completed).
4. Neuropsychological assessment:
5. Thai Depression Inventory.
6. HIV viral load and storage of blood for proviral DNA level
Final outcome assessment based on all available data. If possible, it is intended that these diagnoses will be determined through monthly VTC conference calls with UH investigators. This consensus conference will include the Thai investigators, the UH neurologist, the UH neuropsychologist and the UH principal investigators.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: