Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000143
Status:
COMPLETED
Last Update Posted:
2016-03-14
First Post:
1999-09-23
Brief Title:
Studies of Ocular Complications of AIDS SOCA--Ganciclovir-Cidofovir CMV Retinitis Trial GCCRT
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Johns Hopkins Bloomberg School of Public Health
Study Overview
Official Title:
Studies of Ocular Complications of AIDS SOCA--Ganciclovir-Cidofovir CMV Retinitis Trial GCCRT
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:
GCCRT
Brief Summary:
To compare the newest CMV retinitis drug cidofovir with a regimen of the ganciclovir intraocular device plus oral ganciclovir with respect to efficacy in preventing vision loss
To compare a treatment regimen that incorporates highly active local therapy ganciclovir device with a treatment regimen that does not
To compare a treatment regimen that incorporates highly active local therapy ganciclovir device with a treatment regimen that does not
Detailed Description:
Cytomegalovirus CMV is among the most frequently encountered opportunistic infections in patients with AIDS In the era of prophylaxis for pneumocystic pneumonia CMV disease is estimated to affect 45 percent of patients with AIDS sometime between the diagnosis of AIDS and death Retinitis has been estimated to account for up to 85 percent of CMV disease in these patients making CMV retinitis the most common ocular infection encountered CMV retinitis is a relatively late-stage manifestation associated with cluster of differentiation 4 CD4 T-cell counts 100 cellsµL and often 50 cellsµL
All currently available treatments for CMV suppress viral replication but do not eliminate the virus from the body Discontinuation of therapy is associated with a prompt relapse of the retinitis Despite the use of chronic suppressive therapy relapse of the retinitis generally occurs at least with systemically administered anti-CMV drugs
The first two treatments approved for CMV retinitis were intravenous ganciclovir and intravenous foscarnet Both are given by daily intravenous infusions and therefore require central venous catheters The development of newer treatments has focused not only on efficacious treatments but also on treatments that do not require central venous catheters Available treatments now include oral ganciclovir the ganciclovir intraocular device and intravenous cidofovir
In vitro data suggest that combination therapies are synergistic in inhibiting viral replication these therapies include a foscarnet-ganciclovir combination and a cidofovir-ganciclovir combination In the SOCA--CMV Retinitis Retreatment Trial the combination of intravenous ganciclovir and foscarnet was more effective than either drug alone for the treatment of relapsed retinitis Therefore the combination of intermittent intravenous cidofovir and daily oral ganciclovir may be an attractive therapy for relapsed disease because it may provide synergy for controlling both ocular and visceral disease while not necessitating either a central venous catheter or an intraocular surgical procedure
The Ganciclovir-Cidofovir CMV Retinitis Trial GCCRT is a randomized multicenter clinical trial Patients will be assigned to receive one of two regimens 1 ganciclovir intraocular device plus oral ganciclovir or 2 intravenous cidofovir The intraocular device will be surgically implanted at baseline and again every 6 to 8 months in eyes with CMV retinitis Oral ganciclovir is taken at a dose of 1 gram three times daily Cidofovir will be administered intravenously at 5 mgkg once weekly for 2 consecutive weeks and once every 2 weeks thereafter If disease progression occurs in patients receiving cidofovir patients will be given reinduction therapy and oral ganciclovir at a dose of 1 gram three times per day will be added to the treatment If patients assigned to cidofovir are unable to tolerate that regimen an alternative systemic regimen will be recommended
Study outcome variables include a decrease of three or more lines from baseline in best corrected visual acuity and rate of visual field loss The study will also assess other variables including mortality blood CMV and HIV load quality of life and medical costs
Treatment assignment will not be masked to either patients or clinicians however reading of fundus photographs to determine both change in retinal involvement and progression will be masked
All currently available treatments for CMV suppress viral replication but do not eliminate the virus from the body Discontinuation of therapy is associated with a prompt relapse of the retinitis Despite the use of chronic suppressive therapy relapse of the retinitis generally occurs at least with systemically administered anti-CMV drugs
The first two treatments approved for CMV retinitis were intravenous ganciclovir and intravenous foscarnet Both are given by daily intravenous infusions and therefore require central venous catheters The development of newer treatments has focused not only on efficacious treatments but also on treatments that do not require central venous catheters Available treatments now include oral ganciclovir the ganciclovir intraocular device and intravenous cidofovir
In vitro data suggest that combination therapies are synergistic in inhibiting viral replication these therapies include a foscarnet-ganciclovir combination and a cidofovir-ganciclovir combination In the SOCA--CMV Retinitis Retreatment Trial the combination of intravenous ganciclovir and foscarnet was more effective than either drug alone for the treatment of relapsed retinitis Therefore the combination of intermittent intravenous cidofovir and daily oral ganciclovir may be an attractive therapy for relapsed disease because it may provide synergy for controlling both ocular and visceral disease while not necessitating either a central venous catheter or an intraocular surgical procedure
The Ganciclovir-Cidofovir CMV Retinitis Trial GCCRT is a randomized multicenter clinical trial Patients will be assigned to receive one of two regimens 1 ganciclovir intraocular device plus oral ganciclovir or 2 intravenous cidofovir The intraocular device will be surgically implanted at baseline and again every 6 to 8 months in eyes with CMV retinitis Oral ganciclovir is taken at a dose of 1 gram three times daily Cidofovir will be administered intravenously at 5 mgkg once weekly for 2 consecutive weeks and once every 2 weeks thereafter If disease progression occurs in patients receiving cidofovir patients will be given reinduction therapy and oral ganciclovir at a dose of 1 gram three times per day will be added to the treatment If patients assigned to cidofovir are unable to tolerate that regimen an alternative systemic regimen will be recommended
Study outcome variables include a decrease of three or more lines from baseline in best corrected visual acuity and rate of visual field loss The study will also assess other variables including mortality blood CMV and HIV load quality of life and medical costs
Treatment assignment will not be masked to either patients or clinicians however reading of fundus photographs to determine both change in retinal involvement and progression will be masked
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