Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000665
Status:
COMPLETED
Last Update Posted:
2011-03-14
First Post:
1999-11-02
Brief Title:
Studies of the Ocular Complications of AIDS SOCA CMV Retinitis Trial Foscarnet-Ganciclovir Component
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Studies of the Ocular Complications of AIDS SOCA CMV Retinitis Trial Foscarnet-Ganciclovir Component
Status:
COMPLETED
Status Verified Date:
1994-12
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 evaluate the relative effectiveness and safety of foscarnet versus ganciclovir for the treatment of cytomegalovirus CMV retinitis in people with AIDS to evaluate the relative effect on survival of the use of these two anti-CMV agents in the treatment of CMV retinitis to compare the relative benefits of immediate treatment with foscarnet or ganciclovir versus deferral of treatment for CMV retinitis limited to less than 25 percent of zones 2 and 3
CMV retinitis is a common opportunistic infection in patients with AIDS Ganciclovir is currently the only drug approved for treatment of CMV retinitis in immunocompromised patients Ganciclovir suppresses CMV infections and relapse occurs in virtually all AIDS patients when ganciclovir is discontinued Because of their similar hematologic blood toxicities the simultaneous use of ganciclovir and zidovudine AZT is not recommended More recently the drug foscarnet has become available for investigational use Studies so far indicate that remission of CMV retinitis occurs in 36 to 77 percent of patients and that relapse occurs in virtually all patients when the drug is discontinued The relative effectiveness of foscarnet compared with ganciclovir for the immediate control of CMV infections is unknown Further the long-term effects of foscarnet or ganciclovir on CMV retinitis survival and morbidity are unknown There is also no definitive information on the relative effectiveness and safety of deferred versus immediate treatment for CMV retinitis confined to zones 2 and 3
CMV retinitis is a common opportunistic infection in patients with AIDS Ganciclovir is currently the only drug approved for treatment of CMV retinitis in immunocompromised patients Ganciclovir suppresses CMV infections and relapse occurs in virtually all AIDS patients when ganciclovir is discontinued Because of their similar hematologic blood toxicities the simultaneous use of ganciclovir and zidovudine AZT is not recommended More recently the drug foscarnet has become available for investigational use Studies so far indicate that remission of CMV retinitis occurs in 36 to 77 percent of patients and that relapse occurs in virtually all patients when the drug is discontinued The relative effectiveness of foscarnet compared with ganciclovir for the immediate control of CMV infections is unknown Further the long-term effects of foscarnet or ganciclovir on CMV retinitis survival and morbidity are unknown There is also no definitive information on the relative effectiveness and safety of deferred versus immediate treatment for CMV retinitis confined to zones 2 and 3
Detailed Description:
CMV retinitis is a common opportunistic infection in patients with AIDS Ganciclovir is currently the only drug approved for treatment of CMV retinitis in immunocompromised patients Ganciclovir suppresses CMV infections and relapse occurs in virtually all AIDS patients when ganciclovir is discontinued Because of their similar hematologic blood toxicities the simultaneous use of ganciclovir and zidovudine AZT is not recommended More recently the drug foscarnet has become available for investigational use Studies so far indicate that remission of CMV retinitis occurs in 36 to 77 percent of patients and that relapse occurs in virtually all patients when the drug is discontinued The relative effectiveness of foscarnet compared with ganciclovir for the immediate control of CMV infections is unknown Further the long-term effects of foscarnet or ganciclovir on CMV retinitis survival and morbidity are unknown There is also no definitive information on the relative effectiveness and safety of deferred versus immediate treatment for CMV retinitis confined to zones 2 and 3
Patients are assigned to one of two groups 1 Patients with any retinitis in zone 1 or patients with retinitis involving 25 percent or more of zones 2 and 3 and 2 Patients in whom retinitis is confined to less than 25 percent of zones 2 and 3 of the retina Half the patients in group 1 get immediate treatment with ganciclovir the other half receive immediate treatment with foscarnet Patients in group 2 are treated with foscarnet or ganciclovir either immediately or treatment is deferred If patients in group 2 have strong preferences regarding when therapy is instituted they may elect immediate treatment or deferral of treatment
Patients are assigned to one of two groups 1 Patients with any retinitis in zone 1 or patients with retinitis involving 25 percent or more of zones 2 and 3 and 2 Patients in whom retinitis is confined to less than 25 percent of zones 2 and 3 of the retina Half the patients in group 1 get immediate treatment with ganciclovir the other half receive immediate treatment with foscarnet Patients in group 2 are treated with foscarnet or ganciclovir either immediately or treatment is deferred If patients in group 2 have strong preferences regarding when therapy is instituted they may elect immediate treatment or deferral of treatment
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 |
|---|---|---|---|
| FDA 46A | None | None | None |
| FDA00095 | None | None | None |