Ignite Creation Date:
2024-05-05 @ 9:45 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002134
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Randomized Controlled Study of the Safety and Preventive Efficacy of Oral Ganciclovir When Used in Conjunction With An Intravitreal Ganciclovir Implant in the Treatment of Cytomegalovirus Retinitis
Sponsor:
Roche Global Development
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Randomized Controlled Study of the Safety and Preventive Efficacy of Oral Ganciclovir When Used in Conjunction With An Intravitreal Ganciclovir Implant in the Treatment of Cytomegalovirus Retinitis
Status:
COMPLETED
Status Verified Date:
1997-07
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:
None
Brief Summary:
To demonstrate the efficacy of oral ganciclovir in preventing new cytomegalovirus CMV disease in AIDS patients with unilateral CMV retinitis treated with an intravitreal ganciclovir implant To compare safety and tolerance time to progression quality of life and survival among patients treated with an intravitreal ganciclovir implant with and without oral ganciclovir versus standard intravenous IV ganciclovir therapy
Detailed Description:
Patients receive intravitreal ganciclovir implant plus oral ganciclovir intravitreal implant alone or IV ganciclovir
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 |
|---|---|---|---|
| GANS2304 | None | None | None |