Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004276
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-10-18
Brief Title:
Phase II Placebo Controlled Study of Thalidomide in Patients With Mycobacterial and HIV Infections
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-12
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:
OBJECTIVES I Evaluate whether thalidomide modulates toxic host inflammatory responses in patients receiving antitubercular therapy
II Evaluate whether thalidomide modifies tumor necrosis factor-mediated toxic symptoms of HIV and mycobacterial infections and limits progression of HIV immunodeficiency
III Evaluate whether thalidomide stimulates immunity in patients with HIV andor mycobacterial infections
II Evaluate whether thalidomide modifies tumor necrosis factor-mediated toxic symptoms of HIV and mycobacterial infections and limits progression of HIV immunodeficiency
III Evaluate whether thalidomide stimulates immunity in patients with HIV andor mycobacterial infections
Detailed Description:
PROTOCOL OUTLINE This is a randomized double blind study Patients are stratified by type of infection
Patients are randomly assigned to oral thalidomide or placebo Therapy is administered daily for up to 8 weeks beginning the night before antitubercular treatment is initiated
Patients are randomly assigned to oral thalidomide or placebo Therapy is administered daily for up to 8 weeks beginning the night before antitubercular treatment is initiated
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 |
|---|---|---|---|
| RU-0300395 | None | None | None |