Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000134
Status:
COMPLETED
Last Update Posted:
2015-09-14
First Post:
1999-09-23
Brief Title:
Studies of the Ocular Complications of AIDS SOCA--Cytomegalovirus Retinitis Retreatment Trial CRRT
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Johns Hopkins Bloomberg School of Public Health
Study Overview
Official Title:
Cytomegalovirus Retinitis Retreatment Trial
Status:
COMPLETED
Status Verified Date:
2015-08
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:
CRRT
Brief Summary:
To compare the relative merits of three therapeutic regimens in patients with AIDS and CMV retinitis who have been previously treated but whose retinitis either is nonresponsive or has relapsed These three therapeutic regimens were 1 foscarnet 2 high-dose ganciclovir and 3 combination foscarnet and ganciclovir
To compare two treatment strategies in patients with relapsed or nonresponsive CMV retinitis 1 continuing the same anti-CMV drug or 2 switching to the alternate drug
To compare two treatment strategies in patients with relapsed or nonresponsive CMV retinitis 1 continuing the same anti-CMV drug or 2 switching to the alternate drug
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 At the time of this trial drugs approved by the United States Food and Drug Administration FDA for the treatment of CMV retinitis were ganciclovir Cytovene and foscarnet Foscavir Although most retinitis responds well to initial therapy with systemically administered drugs given enough time nearly all patients will suffer a relapse of the retinitis Relapsed retinitis generally responds to reinduction and maintenance therapy but the interval between successive relapses progressively shortens The CRRT addressed the issue of the management of relapsed CMV retinitis
The CRRT was a multicenter randomized controlled clinical trial comparing three regimens in patients with relapsed retinitis Patients with AIDS and CMV retinitis that had relapsed or was nonresponsive to initial therapy were randomized to one of three regimens 1 intravenous foscarnet reinduction at 90 mgkg twice daily for 2 weeks followed by maintenance therapy at 120 mgkgday 2 intravenous ganciclovir reinduction at 5 mgkg twice daily for 2 weeks followed by maintenance at 10 mgkgday and 3 combination therapy wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mgkgday and ganciclovir at 5 mgkgday
The CRRT was a multicenter randomized controlled clinical trial comparing three regimens in patients with relapsed retinitis Patients with AIDS and CMV retinitis that had relapsed or was nonresponsive to initial therapy were randomized to one of three regimens 1 intravenous foscarnet reinduction at 90 mgkg twice daily for 2 weeks followed by maintenance therapy at 120 mgkgday 2 intravenous ganciclovir reinduction at 5 mgkg twice daily for 2 weeks followed by maintenance at 10 mgkgday and 3 combination therapy wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mgkgday and ganciclovir at 5 mgkgday
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 |
|---|---|---|---|
| U01AI027668 | NIH | None | httpsreporternihgovquickSearchU01AI027668 |
| U10EY008057 | NIH | None | None |