Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001997
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
Safety and Efficacy of Polyethylene Glycolated IL-2 PEG IL-2 Plus Zidovudine or Dideoxyinosine in HIV Positive Asymptomatic and Symptomatic Individuals
Sponsor:
Chiron Corporation
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
Safety and Efficacy of Polyethylene Glycolated IL-2 PEG IL-2 Plus Zidovudine or Dideoxyinosine in HIV Positive Asymptomatic and Symptomatic Individuals
Status:
COMPLETED
Status Verified Date:
1991-07
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 investigate the safety of polyethylene glycolated interleukin-2 PEG IL-2 given subcutaneously in conjunction with antiviral treatment and to explore the effects of treatment on surrogate markers of efficacy and incidence of opportunistic infection and other clinical markers of HIV disease
Detailed Description:
Four escalating doses of PEG IL-2 are studied Patients are stratified by CD4 level CD4 levels in Group A are 200 to 500 cellsmm3 in Group B - 1 to less than 200 cellsmm3 Further stratification is by p24 positive or negative antiviral therapy for more or less than a year and zidovudine AZT versus didanosine ddI The duration of PEG IL-2 treatment is a maximum of 28 weeks This is an outpatient study patients will be observed for four hours after the first dose of PEG IL-2 and for one hour after subsequent doses
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-PG91-07 | None | None | None |