Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000766
Status:
COMPLETED
Last Update Posted:
2011-03-01
First Post:
1999-11-02
Brief Title:
CMV Retinitis Retreatment Trial
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
CMV Retinitis Retreatment Trial
Status:
COMPLETED
Status Verified Date:
2011-02
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 assess the safety and efficacy of three therapeutic regimens foscarnet ganciclovir or the combination for recurrent or persistent AIDS-related cytomegalovirus CMV retinitis
Although therapy with foscarnet or ganciclovir halts retinitis progression in 90 percent of patients treated relapses are common and may accelerate due to development of drug resistance deteriorating immune function or other factors Treatment strategies currently being investigated include switching patients from one drug to the other or combining the two drugs
Although therapy with foscarnet or ganciclovir halts retinitis progression in 90 percent of patients treated relapses are common and may accelerate due to development of drug resistance deteriorating immune function or other factors Treatment strategies currently being investigated include switching patients from one drug to the other or combining the two drugs
Detailed Description:
Although therapy with foscarnet or ganciclovir halts retinitis progression in 90 percent of patients treated relapses are common and may accelerate due to development of drug resistance deteriorating immune function or other factors Treatment strategies currently being investigated include switching patients from one drug to the other or combining the two drugs
Patients are randomized to receive foscarnet ganciclovir or a combination of the two drugs administered sequentially Initially patients undergo single or multiple cycles of induction therapy for 14 days followed by maintenance therapy Patients in whom the retinitis continues to progress or who are intolerant of the initial treatment switch to the alternative drug for further cycles of induction and maintenance Patients on the combination arm in whom retinitis continues to progress are given further cycles of the combination at an increased dose or if one drug is causing toxicity are given further cycles with the alternative drug Patients are followed monthly for 6 months and then every 3 months thereafter
Patients are randomized to receive foscarnet ganciclovir or a combination of the two drugs administered sequentially Initially patients undergo single or multiple cycles of induction therapy for 14 days followed by maintenance therapy Patients in whom the retinitis continues to progress or who are intolerant of the initial treatment switch to the alternative drug for further cycles of induction and maintenance Patients on the combination arm in whom retinitis continues to progress are given further cycles of the combination at an increased dose or if one drug is causing toxicity are given further cycles with the alternative drug Patients are followed monthly for 6 months and then every 3 months thereafter
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?: