Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000709
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
An Open Trial of Zidovudine AZT Treatment of the AIDS Dementia Complex in Patients With AIDS or Low CD4 Lymphocyte Counts
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
An Open Trial of Zidovudine AZT Treatment of the AIDS Dementia Complex in Patients With AIDS or Low CD4 Lymphocyte Counts
Status:
COMPLETED
Status Verified Date:
2021-10
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:
To provide accurate and complete neurologic assessment of the course of the AIDS dementia complex in patients treated with zidovudine AZT The study will determine how frequently patients improve how long improvement is sustained and the magnitude and functional significance of improvement
Individuals with AIDS frequently suffer central nervous system CNS problems that are characterized by cognitive motor and behavioral deficits in a disorder known as AIDS dementia complex Clinical experience suggests that its course is often progressive going from initial symptoms to moderate or severe dementia within several months Accumulating evidence now suggests that direct brain infection by the HIV virus is the likely cause of the AIDS dementia complex Case reports suggest that therapy with AZT which has been shown to be a strong inhibitor of HIV replication in vitro may alleviate the AIDS dementia complex This study will help define the natural history of the AIDS dementia complex in treated patients
Individuals with AIDS frequently suffer central nervous system CNS problems that are characterized by cognitive motor and behavioral deficits in a disorder known as AIDS dementia complex Clinical experience suggests that its course is often progressive going from initial symptoms to moderate or severe dementia within several months Accumulating evidence now suggests that direct brain infection by the HIV virus is the likely cause of the AIDS dementia complex Case reports suggest that therapy with AZT which has been shown to be a strong inhibitor of HIV replication in vitro may alleviate the AIDS dementia complex This study will help define the natural history of the AIDS dementia complex in treated patients
Detailed Description:
Individuals with AIDS frequently suffer central nervous system CNS problems that are characterized by cognitive motor and behavioral deficits in a disorder known as AIDS dementia complex Clinical experience suggests that its course is often progressive going from initial symptoms to moderate or severe dementia within several months Accumulating evidence now suggests that direct brain infection by the HIV virus is the likely cause of the AIDS dementia complex Case reports suggest that therapy with AZT which has been shown to be a strong inhibitor of HIV replication in vitro may alleviate the AIDS dementia complex This study will help define the natural history of the AIDS dementia complex in treated patients
All patients receive AZT for 24 weeks Patients are seen weekly for the first 4 weeks every other week for the next 8 weeks and then every 4 weeks until the completion of the study for neuropsychological evaluation This evaluation includes lumbar puncture and either computerized tomography or magnetic resonance imaging
All patients receive AZT for 24 weeks Patients are seen weekly for the first 4 weeks every other week for the next 8 weeks and then every 4 weeks until the completion of the study for neuropsychological evaluation This evaluation includes lumbar puncture and either computerized tomography or magnetic resonance imaging
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 |
|---|---|---|---|
| 11035 | REGISTRY | DAIDS ES Registry Number | None |