Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000799
Status:
COMPLETED
Last Update Posted:
2012-11-01
First Post:
1999-11-02
Brief Title:
HPMPC Cidofovir Peripheral CMV Retinitis Trial Protocol
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
HPMPC Cidofovir Peripheral CMV Retinitis Trial Protocol
Status:
COMPLETED
Status Verified Date:
2012-10
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 evaluate short-term and long-term safety and efficacy of intravenous cidofovir HPMPC for treatment of small peripheral cytomegalovirus CMV retinitis lesions To provide data on the relative safety and efficacy of 2 doses of HPMPC as maintenance regimens
Detailed Description:
In Stage 1 up to 30 patients are randomized to either observation with deferral of treatment until the retinitis progresses observation group or to intravenous HPMPC at the higher dose for two consecutive weekly induction doses followed by the lower dose every other week for maintenance In Stage 2 up to 70 patients are randomized to observation or to HPMPC at the higher dose for two consecutive weekly induction doses followed by either dose every other week for maintenance for a total of three treatment groups Concomitant saline hydration and probenecid are administered to patients receiving HPMPC
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 |
|---|---|---|---|
| FDA 231A | None | None | None |
| GS-93-105 | None | None | None |