Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000945
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
A Study to Evaluate the Use of Cidofovir an Experimental Drug for the Treatment of Progressive Multifocal Leukoencephalopathy PML in AIDS Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Pilot Study of the Effect of Cidofovir for the Treatment of Progressive Multifocal Leukoencephalopathy PML in Subjects With Acquired Immunodeficiency Syndrome AIDS
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:
The purpose of this study is to evaluate the safety tolerance and overall effectiveness of cidovir to treat PML in AIDS patients
PML is an opportunistic infection HIV-associated due to weak immune system caused by a virus that attacks the brain Cidovir has been used effectively to treat cytomegalovirus CMV of the eye Cidovir could be an effective treatment for PML as well
PML is an opportunistic infection HIV-associated due to weak immune system caused by a virus that attacks the brain Cidovir has been used effectively to treat cytomegalovirus CMV of the eye Cidovir could be an effective treatment for PML as well
Detailed Description:
PML is a demyelinating disease of the brains white matter occurring when the JC virus infects the brain of patients infected with HIV-1 Cidofovir is known to be an effective treatment for cytomegalovirus of the eye and in laboratory and animal testing has also been shown to be effective against several other viruses However cidofovir is considered investigational as a treatment for PML
In this multicenter open-label study 24 patients receive cidofovir iv over 1 hr on days 0 7 then every 2 wk for a total of 13 doses
Oral probenecid is given 3h prior to and 2h and 8h following cidofovir administration Nucleoside and non-nucleoside reverse transcriptors are withheld on days of probenecid administration Protease inhibitors are continued during probenecid administration
In this multicenter open-label study 24 patients receive cidofovir iv over 1 hr on days 0 7 then every 2 wk for a total of 13 doses
Oral probenecid is given 3h prior to and 2h and 8h following cidofovir administration Nucleoside and non-nucleoside reverse transcriptors are withheld on days of probenecid administration Protease inhibitors are continued during probenecid administration
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 |
|---|---|---|---|
| 11327 | REGISTRY | DAIDS ES | None |