Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000856
Status:
WITHDRAWN
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
A Phase III Pilot Treatment Study Of CSF Penetration And Response To Ganciclovir And Foscarnet In CMV Neurologic Disease
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase III Pilot Treatment Study Of CSF Penetration And Response To Ganciclovir And Foscarnet In CMV Neurologic Disease
Status:
WITHDRAWN
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 determine the safety and CSF penetration of combined ganciclovir and foscarnet treatment for presumed cytomegalovirus encephalitis or radiculomyelopathy
This study proposes to investigate the use of combined ganciclovir and foscarnet to maximize the antiviral regimen Current evidence suggests that a combination of ganciclovir and foscarnet may be the most efficacious therapy and appears to be well tolerated This study will provide key information regarding safety and CSF penetration of the drugs available for treatment of these lethal diseases It will also provide preliminary information regarding virologic factors relevant to CMV CNS disease The study will also provide further data about the natural history of CMV brain infection detected by a combination of symptom complex and PCR identification of CMV in CSF and the potential of semi-quantitative PCR evaluation of the CSF for the disease
This study proposes to investigate the use of combined ganciclovir and foscarnet to maximize the antiviral regimen Current evidence suggests that a combination of ganciclovir and foscarnet may be the most efficacious therapy and appears to be well tolerated This study will provide key information regarding safety and CSF penetration of the drugs available for treatment of these lethal diseases It will also provide preliminary information regarding virologic factors relevant to CMV CNS disease The study will also provide further data about the natural history of CMV brain infection detected by a combination of symptom complex and PCR identification of CMV in CSF and the potential of semi-quantitative PCR evaluation of the CSF for the disease
Detailed Description:
This study proposes to investigate the use of combined ganciclovir and foscarnet to maximize the antiviral regimen Current evidence suggests that a combination of ganciclovir and foscarnet may be the most efficacious therapy and appears to be well tolerated This study will provide key information regarding safety and CSF penetration of the drugs available for treatment of these lethal diseases It will also provide preliminary information regarding virologic factors relevant to CMV CNS disease The study will also provide further data about the natural history of CMV brain infection detected by a combination of symptom complex and PCR identification of CMV in CSF and the potential of semi-quantitative PCR evaluation of the CSF for the disease
Patients will be stratified by clinical syndrome as having either primarily A encephalitis or B radiculomyelitis If patient has combined encephalitis and radiculomyelitis then the patient will be stratified as encephalitis CMV therapy with ganciclovir and foscarnet will first be given at an induction level and then a maintenance level For the first 4 weeks patients will be given foscarnet plus ganciclovir Then for the following 20 weeks patients will be given foscarnet plus ganciclovir with ganciclovir at a lower dose NOTE A maximum of 10 patients that have proven to be intolerant to either foscarnet or ganciclovir may receive the alternate agent alone
NOTE Ganciclovir experienced subjects will be given GCV at induction and maintenance doses if tolerated
NOTE Induction doses will not be re-started in the face of clinical relapse on switching to maintenance therapy
Patients will be stratified by clinical syndrome as having either primarily A encephalitis or B radiculomyelitis If patient has combined encephalitis and radiculomyelitis then the patient will be stratified as encephalitis CMV therapy with ganciclovir and foscarnet will first be given at an induction level and then a maintenance level For the first 4 weeks patients will be given foscarnet plus ganciclovir Then for the following 20 weeks patients will be given foscarnet plus ganciclovir with ganciclovir at a lower dose NOTE A maximum of 10 patients that have proven to be intolerant to either foscarnet or ganciclovir may receive the alternate agent alone
NOTE Ganciclovir experienced subjects will be given GCV at induction and maintenance doses if tolerated
NOTE Induction doses will not be re-started in the face of clinical relapse on switching to maintenance therapy
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 |
|---|---|---|---|
| 11280 | REGISTRY | DAIDS ES Registry Number | None |