Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000136
Status:
COMPLETED
Last Update Posted:
2015-10-22
First Post:
1999-09-23
Brief Title:
Studies of the Ocular Complications of AIDS SOCA--Foscarnet-Ganciclovir CMV Retinitis Trial FGCRT
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Johns Hopkins Bloomberg School of Public Health
Study Overview
Official Title:
Foscarnet-Ganciclovir CMV Retinitis Trial
Status:
COMPLETED
Status Verified Date:
2015-07
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:
FGCRT
Brief Summary:
To evaluate the relative safety and efficacy of ganciclovir and foscarnet as initial treatment of patients with cytomegalovirus CMV retinitis
Detailed Description:
CMV retinitis is the most common intraocular infection in patients with AIDS and is estimated to affect 35 to 40 percent of patients with AIDS Untreated CMV retinitis is a progressive disorder the end result of which is total retinal destruction and blindness The first two drugs approved by the United States Food and Drug Administration FDA for the treatment of CMV retinitis were ganciclovir Cytovene and foscarnet Foscavir At the time of this trial both ganciclovir and foscarnet were available only as intravenous formulations Both drugs were given in a similar two-step fashion an initial 2-week course of high-dose therapy induction to control the infection followed by long-term lower dose therapy to prevent relapse maintenance The FGCRT compared foscarnet and ganciclovir as initial therapy for CMV retinitis
The FGCRT was a multicenter randomized controlled clinical trial comparing foscarnet and ganciclovir as initial therapy for CMV retinitis Patients with previously untreated CMV retinitis were randomized to therapy with either intravenous ganciclovir or intravenous foscarnet The outcome measures of this trial were survival retinitis progression loss of visual function visual acuity and visual field and morbidity
The FGCRT was a multicenter randomized controlled clinical trial comparing foscarnet and ganciclovir as initial therapy for CMV retinitis Patients with previously untreated CMV retinitis were randomized to therapy with either intravenous ganciclovir or intravenous foscarnet The outcome measures of this trial were survival retinitis progression loss of visual function visual acuity and visual field and morbidity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10EY008057 | NIH | None | httpsreporternihgovquickSearchU10EY008057 |