Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002355
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Comparison of ISIS 2922 Used Immediately or Later in Patients With Cytomegalovirus CMV of the Eyes
Sponsor:
Ionis Pharmaceuticals Inc
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Randomized Comparison of Immediate Versus Delayed Treatment With Intravitreal Injections of ISIS 2922 in Patients With Peripheral Cytomegalovirus CMV Retinitis
Status:
COMPLETED
Status Verified Date:
1998-07
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 determine a clinically safe and effective dose of intravitreally injected ISIS 2922 and to compare the safety and efficacy of immediate versus delayed treatment in AIDS patients with previously untreated peripheral cytomegalovirus CMV retinitis
Detailed Description:
In Stage 1 dose escalation patients receive either 75 or 150 mcg intravitreal ISIS 2922 In Stage 2 randomization patients are enrolled in either the immediate treatment group or delayed treatment group Immediate treatment consists of intravitreal ISIS 2922 every 7 days for 3 injections Induction then every 14 days for 18 weeks Maintenance Patients in the delayed treatment group receive no immediate anti-CMV treatment but are monitored weekly for disease progression If disease progresses patient receives ISIS 2922 on an identical dosage regimen as those on immediate treatment Patients may continue ISIS 2922 on a biweekly extended maintenance schedule if dose is considered safe and the 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-CS2 | None | None | None |