Ignite Creation Date:
2024-05-05 @ 1:26 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002246
Status:
COMPLETED
Last Update Posted:
2011-05-04
First Post:
1999-11-02
Brief Title:
A Study to Evaluate the Use of Stavudine d4T to Treat AIDS Dementia Complex
Sponsor:
Bristol-Myers Squibb
Organization:
Bristol-Myers Squibb
Study Overview
Official Title:
A Pilot Open Label Multicenter Study to Evaluate the Role of Stavudine d4T in the Treatment of AIDS Dementia Complex
Status:
COMPLETED
Status Verified Date:
2011-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 if adding stavudine d4T to anti-HIV drug regimens with or without zidovudine ZDV can improve symptoms of AIDS Dementia Complex ADC problems involving the brain or spinal cord in HIV-positive patients
Detailed Description:
In this open-label multicenter multinational study ZDV is replaced with d4T in ZDV-containing regimens or d4T is added to non-ZDV-containing regimens in 20 patients experiencing ADC Patients are defined as having failed treatment if they progress by one ADC stage on the MSK Memorial Sloan Kettering rating scale on study ie from Stage 1 to 2 or Stage 2 to 3 Patients are evaluated on a weekly basis until the dementia deterioration is confirmed to be caused by HIV-1 The effect of d4T-containing regimens is assessed for the following parameters neurological status survival AIDS-defining conditions CSF cerebrospinal fluid and plasma viral load CSF and blood immunological markers blood CD4 cell counts and viral resistance This study also assesses the pharmacokinetics of d4T in the CSF and in the blood
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 |
|---|---|---|---|
| AI455-064 | None | None | None |