Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001062
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Study of Ganciclovir in the Treatment of Cytomegalovirus of the Eyes
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I Study of a Fixed-Schedule Regimen of Alternating Oral and Intravenous Ganciclovir for Treatment of Cytomegalovirus Retinitis
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:
To determine whether alternating oral ganciclovir with intravenous IV ganciclovir can prevent relapse of Cytomegalovirus CMV retinitis and improve quality of life in AIDS patients
A systemic treatment strategy for CMV retinitis is needed that will be effective yet convenient to administer without the need for a permanent indwelling IV catheter Although oral ganciclovir has been used as maintenance following induction with IV ganciclovir patients with reactivation of disease must be reinduced IV A fixed-schedule regimen in which oral and IV ganciclovir are alternated may prevent reactivation and progression of disease as opposed to the current therapeutic strategy in which changes in therapy are event-driven Also the duration of intermittent IV therapy required to control disease may be short enough to eliminate the need for an indwelling catheter
A systemic treatment strategy for CMV retinitis is needed that will be effective yet convenient to administer without the need for a permanent indwelling IV catheter Although oral ganciclovir has been used as maintenance following induction with IV ganciclovir patients with reactivation of disease must be reinduced IV A fixed-schedule regimen in which oral and IV ganciclovir are alternated may prevent reactivation and progression of disease as opposed to the current therapeutic strategy in which changes in therapy are event-driven Also the duration of intermittent IV therapy required to control disease may be short enough to eliminate the need for an indwelling catheter
Detailed Description:
A systemic treatment strategy for CMV retinitis is needed that will be effective yet convenient to administer without the need for a permanent indwelling IV catheter Although oral ganciclovir has been used as maintenance following induction with IV ganciclovir patients with reactivation of disease must be reinduced IV A fixed-schedule regimen in which oral and IV ganciclovir are alternated may prevent reactivation and progression of disease as opposed to the current therapeutic strategy in which changes in therapy are event-driven Also the duration of intermittent IV therapy required to control disease may be short enough to eliminate the need for an indwelling catheter
Patients receive IV induction with ganciclovir for 2 weeks followed by an alternating course of 3 weeks of oral ganciclovir and 1 week of IV drug for four cycles 16 weeks If CMV retinitis fails to arrest after initial induction IV ganciclovir is administered for an additional 2 weeks
Patients receive IV induction with ganciclovir for 2 weeks followed by an alternating course of 3 weeks of oral ganciclovir and 1 week of IV drug for four cycles 16 weeks If CMV retinitis fails to arrest after initial induction IV ganciclovir is administered for an additional 2 weeks
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 |
|---|---|---|---|
| 11254 | REGISTRY | DAIDS ES Registry Number | None |