Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000894
Status:
COMPLETED
Last Update Posted:
2011-02-23
First Post:
1999-11-02
Brief Title:
Comparison of Two Drugs Cidofovir and Ganciclovir in Treating Patients With AIDS Who Have CMV Retinitis
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Ganciclovir-Cidofovir CMV Retinitis Trial GCCRT
Status:
COMPLETED
Status Verified Date:
2003-06
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 compare cidofovir with a commonly used treatment regimen ganciclovir given by mouth oral and through an eye device intraocular in order to determine the safety and effectiveness of cidofovir in preventing vision loss in patients who have AIDS complicated by CMV cytomegalovirus retinitis
Cidofovir needs to be compared to ganciclovir to determine the best way to treat CMV retinitis
Cidofovir needs to be compared to ganciclovir to determine the best way to treat CMV retinitis
Detailed Description:
While cidofovir is effective in suppressing retinitis and prolonging time to progression no studies have compared cidofovir to other therapies and its place in the treatment of CMV retinitis remains unexplored By combining the ganciclovir intraocular device slows retinitis progression with oral ganciclovir has the potential to treat both the ocular disease and to suppress dissemination to the contralateral eye and the viscera without the use of a central venous catheter this combination has become increasingly common For these reasons a comparative trial of cidofovir to other therapies is appropriate
After being stratified by the clinic and by stage of disease patients are randomized to 1 of 2 treatment arms intravenous IV cidofovir Group I or intraocular ganciclovir device plus oral ganciclovir Group II Group I Cidofovir is administered IV once weekly for 2 consecutive weeks then every 2 weeks thereafter If progression occurs oral ganciclovir is added to treatment or if this regimen is not tolerated patients are treated according to the best medical judgment Concurrent oral probenecid and intravenous hydration are administered with each cidofovir infusion Group II An intraocular ganciclovir device is surgically implanted at baseline and then every 6 to 8 months and ganciclovir is administered orally If more than 1 progression or unacceptable toxicity occurs patients are treated according to the best medical judgment
After being stratified by the clinic and by stage of disease patients are randomized to 1 of 2 treatment arms intravenous IV cidofovir Group I or intraocular ganciclovir device plus oral ganciclovir Group II Group I Cidofovir is administered IV once weekly for 2 consecutive weeks then every 2 weeks thereafter If progression occurs oral ganciclovir is added to treatment or if this regimen is not tolerated patients are treated according to the best medical judgment Concurrent oral probenecid and intravenous hydration are administered with each cidofovir infusion Group II An intraocular ganciclovir device is surgically implanted at baseline and then every 6 to 8 months and ganciclovir is administered orally If more than 1 progression or unacceptable toxicity occurs patients are treated according to the best medical judgment
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?: