Ignite Creation Date:
2024-05-05 @ 10:05 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004794
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Phase II Randomized Study of Cidofovir for Peripheral Cytomegalovirus Retinitis
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1998-01
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:
OBJECTIVES I Evaluate the safety and efficacy of intravenous cidofovir in patients with small peripheral cytomegalovirus retinitis
II Obtain safety and efficacy data related to different dosages of cidofovir
II Obtain safety and efficacy data related to different dosages of cidofovir
Detailed Description:
PROTOCOL OUTLINE This is a randomized study Cidofovir is administered intravenously Treatment ideally begins within 24 hours of randomization
In the first group therapy is deferred until disease progression Patients are then treated according to best medical judgement which includes the option of cidofovir therapy
The second group receives induction with cidofovir every 7 days for 2 weeks then begins maintenance with a low dose given every 14 days until dose-limiting toxicity or disease progression occurs
The third group receives the same cidofovir induction followed by a high maintenance dose given every 14 days until dose-limiting toxicity or disease progression occurs
Probenecid and intravenous hydration are administered concurrently with cidofovir
Patients are followed for progression and survival every 2 weeks for 23 weeks then every 12 weeks At disease progression patients may be re-treated with another course of induction and maintenance
In the first group therapy is deferred until disease progression Patients are then treated according to best medical judgement which includes the option of cidofovir therapy
The second group receives induction with cidofovir every 7 days for 2 weeks then begins maintenance with a low dose given every 14 days until dose-limiting toxicity or disease progression occurs
The third group receives the same cidofovir induction followed by a high maintenance dose given every 14 days until dose-limiting toxicity or disease progression occurs
Probenecid and intravenous hydration are administered concurrently with cidofovir
Patients are followed for progression and survival every 2 weeks for 23 weeks then every 12 weeks At disease progression patients may be re-treated with another course of induction and maintenance
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 |
|---|---|---|---|
| NU-506 | None | None | None |