Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002222
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study of Valganciclovir in the Treatment of Cytomegalovirus CMV Retinitis in Patients With AIDS
Sponsor:
Hoffmann-La Roche
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
An Open Label Study of the Safety and Tolerability of Valganciclovir an Oral Prodrug of Ganciclovir for the Treatment of Cytomegalovirus Retinitis in Subjects With AIDS
Status:
COMPLETED
Status Verified Date:
1999-04
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 see if valganciclovir is a safe treatment for CMV retinitis in patients who have been treated for this condition in the past This study also examines the effectiveness of valganciclovir in preventing the recurrence of CMV retinitis
Detailed Description:
Patients receive valganciclovir twice a day for 21 days as induction therapy then daily as maintenance therapy Patients are encouraged to remain on study for at least 3 months and will remain until common study closure
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?: