Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002449
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
Safety and Effectiveness of L2-7001 Interleukin-2 in HIV-Positive Patients Receiving Anti-HIV Therapy
Sponsor:
Chiron Corporation
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Bridging Dose-Escalation Study of the Safety Pharmacokinetic Properties and Immunologic Effect of Subcutaneous L2-7001 Recombinant Human Interleukin-2 in Patients Infected With HIV With CD4 T-Cell Counts of 300 to 500 Cellsmm3 and Viral Burden Under 10000 CopiesMl on Active Antiretroviral Therapy ART
Status:
UNKNOWN
Status Verified Date:
2001-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
The purpose of this study is to see if it is safe and effective to give HIV-positive patients L2-7001 a type of interleukin-2 plus anti-HIV therapy Interleukin-2 IL-2 is a substance naturally produced by the bodys white blood cells that plays an important role in helping the body fight infection IL-2 may be able to boost the immune systems of people with HIV infection
Detailed Description:
This study takes place in two phases Phase A consists of an open-label dose-escalation of L2-7001 through four dose levels Ascending dose cohorts of five patients are studied The safety and tolerability of L2-7001 is assessed in preparation for the second phase of the study and to estimate an MTD Phase B involves randomization of 190 patients to a one of three dose levels of L2-7001 plus ART b one of two dosing levels of Proleukin plus ART or c ART alone L2-7001 and Proleukin are given SC every 12 hours for the first 5 days of an 8-week cycle for three cycles Serum IL-2 levels soluble IL-2 receptor levels and levels of pro-inflammatory cytokines are evaluated in 8 patients randomized to each treatment cohort of Phase B All patients completing this phase of the protocol are eligible to be screened for enrollment in a maintenance use protocol which will allow for access to L2-7001
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 |
|---|---|---|---|
| CS-MM-9901 | None | None | None |