Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002156
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis CMVR
Sponsor:
Ionis Pharmaceuticals Inc
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis CMVR
Status:
COMPLETED
Status Verified Date:
1998-12
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 determine the clinically safe and effective dose of intravitreal ISIS 2922 alone and as an additive antiviral therapy to ganciclovir in AIDS patients with cytomegalovirus CMV retinitis
Detailed Description:
In Stage 1 of the study 20 patients receive one of two doses of ISIS 2922 on days 1 8 and 15 Induction then every 14 days maintenance with ganciclovir given daily during both Induction and Maintenance Escalation to the second dose does not occur until all patients at the first dose level have reached their first maintenance dose day 29 In Stage 2 of the study 174 patients are randomized to receive either a ISIS 2922 at the dose established in Stage 1 on days 1 8 and 15 and then every 14 days with ganciclovir given daily during both Induction and Maintenance or b ganciclovir daily for 14 consecutive days and then a lower dose as maintenance Patients may continue to receive ISIS 2922 biweekly if the dose is safe and their CMV retinitis is clinically controlled Per 2896 amendment patients are now in Stage 2 at 150 mcg
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 |
|---|---|---|---|
| ISIS 2922-CS3 | None | None | None |