Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000702
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
A Multicenter Placebo-Controlled Double-Blind Trial to Evaluate Azidothymidine AZT Treatment of the AIDS Dementia Complex and Central Nervous System CNS Human Immunodeficiency Virus HIV Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Multicenter Placebo-Controlled Double-Blind Trial to Evaluate Azidothymidine AZT Treatment of the AIDS Dementia Complex and Central Nervous System CNS Human Immunodeficiency Virus HIV Infection
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 test whether zidovudine AZT is useful as a treatment for the neurologic syndrome called AIDS dementia complex To determine how long AZT takes to reach cerebral spinal fluid CSF how long and at what concentration it is found there
HIV infection can result in impairment in the function of the brain and spinal cord leading to disturbances in the ability to think clearly and in strength and coordination This disorder which has been called the AIDS dementia complex may be due to a direct effect of HIV on the nervous system It is known that AZT does get into the brain to some extent where it may reduce growth of HIV It is hoped that AZT will stabilize or improve the symptoms of the AIDS dementia complex
HIV infection can result in impairment in the function of the brain and spinal cord leading to disturbances in the ability to think clearly and in strength and coordination This disorder which has been called the AIDS dementia complex may be due to a direct effect of HIV on the nervous system It is known that AZT does get into the brain to some extent where it may reduce growth of HIV It is hoped that AZT will stabilize or improve the symptoms of the AIDS dementia complex
Detailed Description:
HIV infection can result in impairment in the function of the brain and spinal cord leading to disturbances in the ability to think clearly and in strength and coordination This disorder which has been called the AIDS dementia complex may be due to a direct effect of HIV on the nervous system It is known that AZT does get into the brain to some extent where it may reduce growth of HIV It is hoped that AZT will stabilize or improve the symptoms of the AIDS dementia complex
The study is done in 2 stages In Stage 1 patients are randomized to receive placebo or 1 of 2 doses of AZT Stage 1 lasts for 4 months In Stage 2 patients who were initially treated with placebo are randomized again and all patients receive AZT Stage 2 lasts an additional 12 months during which time there are periodic medical and neurologic evaluations Before beginning treatment all patients have a lumbar puncture and a computerized tomographic CT scan of the brain The lumbar puncture is repeated twice during and once at the end of Stage 1 the CT scan is also repeated at the end of Stage 1 Patients receiving AZT in either stage 1 or Stage 2 are seen by their physicians every week for the first 4 weeks and every other week thereafter for the first 4 months of receiving the drug After 4 months patients are seen by their physicians at 4 to 12 week intervals
The study is done in 2 stages In Stage 1 patients are randomized to receive placebo or 1 of 2 doses of AZT Stage 1 lasts for 4 months In Stage 2 patients who were initially treated with placebo are randomized again and all patients receive AZT Stage 2 lasts an additional 12 months during which time there are periodic medical and neurologic evaluations Before beginning treatment all patients have a lumbar puncture and a computerized tomographic CT scan of the brain The lumbar puncture is repeated twice during and once at the end of Stage 1 the CT scan is also repeated at the end of Stage 1 Patients receiving AZT in either stage 1 or Stage 2 are seen by their physicians every week for the first 4 weeks and every other week thereafter for the first 4 months of receiving the drug After 4 months patients are seen by their physicians at 4 to 12 week intervals
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 |
|---|---|---|---|
| 10981 | REGISTRY | DAIDS ES Registry Number | None |