Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002439
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study of ALRT 1057 Topical Gel in Patients With AIDS-Related Kaposis Sarcoma
Sponsor:
Anderson Clinical Research
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
Randomized Phase III Vehicle Controlled Trial of ALRT 1057 Topical Gel in Patients With AIDS-Related Kaposis Sarcoma
Status:
COMPLETED
Status Verified Date:
1997-08
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 ALRT1057 gel is safe and effective in treating Kaposis sarcoma KS when applied to skin
Detailed Description:
This is a Phase 3 double-blind study KS patients are randomized to 1 of 2 treatment arms They receive either ALRT1057 gel or placebo for 12 weeks If progressive disease for KS is noted before Week 12 patients are switched to the other blinded treatment arm If a response or disease progression that has not persisted for at least 4 weeks as of Week 12 occurs treatment on the blinded arm is continued for up to 4 additional weeks or until response of disease progression is confirmed After that time or after 12 weeks of treatment open-label ALRT1057 may be received
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 |
|---|---|---|---|
| 96ACR-LIG1 | None | None | None |
| L1057T-31 | None | None | None |