Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002445
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
Safety and Effectiveness of an Experimental Drug IM862 in Treating Kaposis Sarcoma in AIDS Patients
Sponsor:
Cytran
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase III Randomized Placebo Controlled and Double Blinded Study of IM862 for Patients With Muco-Cutaneous AIDS Associated Kaposis Sarcoma
Status:
COMPLETED
Status Verified Date:
2001-06
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:
The purpose of this study is to see if it is safe and effective to use IM862 to treat Kaposis sarcoma KS in AIDS patients
Detailed Description:
Patients are stratified by CD4 count viral load and prior systemic chemotherapy Patients are randomized equally to receive either IM862 or placebo given intranasally every other day Patients are seen every 4 weeks for 6 months or until disease progression to evaluate toxicity and efficacy Quality of life is assessed before treatment then every month for 6 months At the end of the 6-month study evaluation period patients with PRCR responders remain on study and continue blinded treatment for an additional 6 months For patients with stable disease non-responders the treatment assignment is unblinded and off-study IM862 compassionate use is offered for 6 months regardless of treatment group For patients with documented progressive disease treatment failure the treatment assignment is unblinded and off-study IM862 is offered for 6 months to any patient in the placebo group For treatment failures in the IM862 group IM862 is stopped and the patient is allowed other therapy options
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 |
|---|---|---|---|
| AMC-013 | None | None | None |
| KS-20898-01 | None | None | None |