Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002157
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
Compassionate Use Study of Two Dose Levels of Thalidomide in Adults With HIV Wasting Syndrome
Sponsor:
Celgene Corporation
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
Compassionate Use Study of Two Dose Levels of Thalidomide in Adults With HIV Wasting Syndrome
Status:
COMPLETED
Status Verified Date:
1998-12
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:
To allow patients with HIV-associated wasting to receive thalidomide treatment at 1 of 2 doses To gain safety and efficacy data from a broader base of patients with HIV-associated wasting in order to support Celgenes pivotal placebo-controlled study
Detailed Description:
Patients are randomized to receive thalidomide at 1 of 2 doses for 12 weeks initially with response assessed at weeks 2 4 8 and 12 Patients failing the low dose will be eligible to increase the dose to the higher dose Treatment may continue indefinitely After 12 weeks patients continuing treatment are evaluated every 2 months for up to 6 additional months then every 6 months thereafter
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-002 | None | None | None |