Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001048
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
1999-11-02
Brief Title:
Comparison of Anti HIV Drugs Used Alone or in Combination With Cytosine Arabinoside to Treat Progressive Multifocal Leukoencephalopathy PML in HIV-Infected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase II Multicenter Study Comparing Antiretroviral Therapy Alone to Antiretroviral Therapy Plus Cytosine Arabinoside Cytarabine Ara-C for the Treatment of Progressive Multifocal Leukoencephalopathy PML in Human Immunodeficiency Virus HIV-Infected Subjects
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 compare the safety and efficacy of antiretroviral therapy zidovudine plus either didanosine or dideoxycytidine versus antiretroviral therapy plus intravenous cytarabine Ara-C versus antiretroviral therapy plus intrathecal Ara-C in the maintenance or improvement of neurological function over 6 months in HIV-infected individuals who have developed progressive multifocal leukoencephalopathy PML To compare the effect of these three treatment regimens on Karnofsky score and MRI studies
The effectiveness of Ara-C in the treatment of PML caused by a human DNA papovavirus designated JC virus infection has not been determined although the most encouraging results have occurred with intrathecal administration of the drug
The effectiveness of Ara-C in the treatment of PML caused by a human DNA papovavirus designated JC virus infection has not been determined although the most encouraging results have occurred with intrathecal administration of the drug
Detailed Description:
The effectiveness of Ara-C in the treatment of PML caused by a human DNA papovavirus designated JC virus infection has not been determined although the most encouraging results have occurred with intrathecal administration of the drug
Patients are randomized to receive antiretroviral therapy alone AZT plus ddI or ddC antiretroviral therapy plus intravenous Ara-C or antiretroviral therapy plus intrathecal Ara-C All patients receive 24 weeks of antiretroviral therapy Beginning at week 2 patients on the intravenous Ara-C arm receive daily infusions of Ara-C over 5 days with cycles repeating every 21 days Patients on the intrathecal Ara-C arm receive single administrations of Ara-C at weeks 2 3 4 5 6 8 10 12 16 20 and 24 A brain biopsy confirmation or in situ hybridization will be required within 7 days after study entry Patients are followed every 4 weeks
Patients are randomized to receive antiretroviral therapy alone AZT plus ddI or ddC antiretroviral therapy plus intravenous Ara-C or antiretroviral therapy plus intrathecal Ara-C All patients receive 24 weeks of antiretroviral therapy Beginning at week 2 patients on the intravenous Ara-C arm receive daily infusions of Ara-C over 5 days with cycles repeating every 21 days Patients on the intrathecal Ara-C arm receive single administrations of Ara-C at weeks 2 3 4 5 6 8 10 12 16 20 and 24 A brain biopsy confirmation or in situ hybridization will be required within 7 days after study entry Patients are followed every 4 weeks
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 |
|---|---|---|---|
| 11220 | REGISTRY | DAIDS-ES | None |