Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002017
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
Immunomodulation of HIV-1 Infected Individuals With PEG-Interleukin-2
Sponsor:
Rockefeller University
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
Immunomodulation of HIV-1 Infected Individuals With PEG-Interleukin-2
Status:
COMPLETED
Status Verified Date:
1991-08
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 and immunological effects of polyethylene glycolated-interleukin-2 PEG-IL-2 on asymptomatic without symptoms HIV-seropositive patients who are taking zidovudine AZT To enhance measures of immune function with well-tolerated doses of PEG-IL-2 an immunomodulator in a regimen designed to allow its use in outpatients with normal daily activity ie full-time employment etc Recombinant IL-2 without PEG modification was administered to HIV-infected patients by daily intradermal injection At the low doses used this was non-toxic well-tolerated and gave a systemic response as measured by natural killer cell and lymphokine-activated killer cell activity but required daily administration In the current study the PEG modification of IL-2 is used since it has a much longer prolonged half-life compared with the non-PEG compound without loss of functional activity
Detailed Description:
Recombinant IL-2 without PEG modification was administered to HIV-infected patients by daily intradermal injection At the low doses used this was non-toxic well-tolerated and gave a systemic response as measured by natural killer cell and lymphokine-activated killer cell activity but required daily administration In the current study the PEG modification of IL-2 is used since it has a much longer prolonged half-life compared with the non-PEG compound without loss of functional activity
In the first dose-escalation phase of the study PEG-IL-2 is injected into the skin of the back by either the intradermal ID or subcutaneous SC route to establish an optimal dose which when given ID results in local induration or 25 mm without significant toxicity The ID and SC routes are compared for systemic effect and toxicity In the second phase of the study the PEG-IL-2 is administered for 6-8 weeks using the optimal dosage frequency and route determined in the initial phase probably 2-3 times per week while local and systemic effects are monitored These include measures of viral titer peripheral blood mononuclear cell phenotype CBC and CD4 counts and in vitro cytotoxicity assays
In the first dose-escalation phase of the study PEG-IL-2 is injected into the skin of the back by either the intradermal ID or subcutaneous SC route to establish an optimal dose which when given ID results in local induration or 25 mm without significant toxicity The ID and SC routes are compared for systemic effect and toxicity In the second phase of the study the PEG-IL-2 is administered for 6-8 weeks using the optimal dosage frequency and route determined in the initial phase probably 2-3 times per week while local and systemic effects are monitored These include measures of viral titer peripheral blood mononuclear cell phenotype CBC and CD4 counts and in vitro cytotoxicity assays
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 |
|---|---|---|---|
| COH-010-0790 | None | None | None |