Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002104
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
Placebo-Controlled Trial of Safety and Efficacy of Thalidomide in Patients With Infections Due to Mycobacterium andor HIV
Sponsor:
Aaron Diamond AIDS Research Center
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
Placebo-Controlled Trial of Safety and Efficacy of Thalidomide in Patients With Infections Due to Mycobacterium andor HIV
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 demonstrate in patients with tubercular or nontubercular mycobacterium infections with or without HIV infection the safety of thalidomide use as judged by symptoms physical exam and studies of microbiologic immunologic hematologic renal and hepatic status To demonstrate efficacy of the drug as judged by status of fever nutrition tuberculosis lesions and immune responses
Detailed Description:
Patients are randomized to receive thalidomide or placebo orally at 9 PM the night before beginning anti-tuberculosis chemotherapy and continuing nightly for 7 nights Patients are followed for 28 days Patients are stratified according to HIV status and stage of HIV infection
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?: