Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001282
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
A Phase III Study of the Combination of Azidothymidine and Interleukin-2 IL-2 in the Treatment of HIV-Infected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase III Study of the Combination of Azidothymidine and Interleukin-2 IL-2 in the Treatment of HIV-Infected Patients
Status:
COMPLETED
Status Verified Date:
2002-04
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:
This study will evaluate the long-term toxicity and obtain preliminary information about long-term efficacy of the combination of antiretroviral therapies and interleukin-2 IL-2 a cytokine with immunomodulatory properties Currently 73 patients have been approved to receive IL-2 at a starting dose of 18 MIUd for 5 days Multiple courses of IL-2 will be administered at approximately 2 month intervals Clinical laboratory immunologic and viral parameters will be closely monitored during this time for evidence of toxicity and preliminary evidence of efficacy
Detailed Description:
This study will evaluate the long-term toxicity and obtain preliminary information about long-term efficacy of the combination of antiretroviral therapies and interleukin-2 IL-2 a cytokine with immunomodulatory properties Currently 73 patients have been approved to receive IL-2 at a starting dose of 18 MIUd for 5 days Multiple courses of IL-2 will be administered at approximately 2 month intervals Clinical laboratory immunologic and viral parameters will be closely monitored during this time for evidence of toxicity and preliminary evidence of efficacy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 91-I-0143 | None | None | None |