Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002127
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Phase II Parallel Group Randomized Placebo-Controlled Study of the Safety and Efficacy of Thalidomide in Reducing Weight Loss in Adults With HIV Wasting Syndrome
Sponsor:
Celgene Corporation
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase II Parallel Group Randomized Placebo-Controlled Study of the Safety and Efficacy of Thalidomide in Reducing Weight Loss in Adults With HIV Wasting Syndrome
Status:
COMPLETED
Status Verified Date:
1997-07
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 evaluate the safety antiviral and anti-TNF-alpha activity and preliminary efficacy of thalidomide in reducing weight loss in patients with HIV wasting syndrome
Detailed Description:
Patients are randomized to receive either thalidomide at 1 of 2 doses or placebo for 8 weeks Patients who respond may continue in double-blinded treatment for an additional 4 weeks nonresponding patients may receive thalidomide for up to 4 weeks Per amendment patients may receive thalidomide for more than 12 weeks on a compassionate basis
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 |
|---|---|---|---|
| W-001 | None | None | None |