Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000664
Status:
COMPLETED
Last Update Posted:
2008-08-04
First Post:
1999-11-02
Brief Title:
Safety and Efficacy of Polyethylene Glycolated IL-2 PEG IL-2 Plus Zidovudine in HIV Positive Asymptomatic and Symptomatic Individuals
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Safety and Efficacy of Polyethylene Glycolated IL-2 PEG IL-2 Plus Zidovudine in HIV Positive Asymptomatic and Symptomatic Individuals
Status:
COMPLETED
Status Verified Date:
1994-12
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 determine the safety of polyethylene glycolated IL-2 PEG IL2 administered weekly or biweekly per amendment in a setting of oral zidovudine AZT To determine the effect of PEG IL2 in combination with AZT on parameters assessing the immune system as well as HIV virus and antibody titers To evaluate a chronic dosing study phase offered to patients who complete the initial 25-week regimen
Recent research has focused on enhancing cell-mediated immunity and reducing or eliminating viral replication reproduction and growth A main thrust of current treatment is the combination of antiviral drugs that may be more effective when combined than when each is used alone
Recent research has focused on enhancing cell-mediated immunity and reducing or eliminating viral replication reproduction and growth A main thrust of current treatment is the combination of antiviral drugs that may be more effective when combined than when each is used alone
Detailed Description:
Recent research has focused on enhancing cell-mediated immunity and reducing or eliminating viral replication reproduction and growth A main thrust of current treatment is the combination of antiviral drugs that may be more effective when combined than when each is used alone
Four groups are studied for a period of at least 25 weeks Patients are observed for a minimum of 6 hours after infusion of PEG IL2 The 4 groups of patients are Group A - asymptomatic with T4 count 400 cellsmm3 7 patients Group B - asymptomatic with T4 count between 200 and 400 cellsmm3 7 patients Group C - asymptomatic with T4 count 200 cellsmm3 5 patients Group D - diagnosed as having AIDS related complex ARC or AIDS 7 patients All patients receive AZT After a minimum 2-week period of AZT patients receive an infusion of PEG IL-2 at 3 consecutive weekly intervals followed by a 3-week period of AZT alone This cycle 3 weeks of AZT and PEG IL-2 followed by 3 weeks of AZT alone is repeated a total of three times for a total of 18 weeks followed by 8 weeks of AZT alone
PER AMENDMENT Ten patients may qualify for one of two groups Group 1 - T4 count 200 - 400 cellsmm3 and meet all criteria established for Group B of the original protocol Group 2 - T4 count 200 cellsmm3 and meet all criteria established for Groups C and D of original protocol Patients will receive an amended schedule of PEG IL2 IV every other week for eight doses with dose escalation every other week for eight weeks permitted only in Group 2 patients who failed to show a 20 percent rise in T4 count at week 9 and who suffered no CNS or other adverse events at the lower dose
PER ADDITIONAL AMENDMENT Up to 10 additional patients may be treated at each dose of PEG IL2 on the biweekly schedule Patients who respond to treatment on the biweekly schedule are eligible for an additional 9 weeks at their current dose
Four groups are studied for a period of at least 25 weeks Patients are observed for a minimum of 6 hours after infusion of PEG IL2 The 4 groups of patients are Group A - asymptomatic with T4 count 400 cellsmm3 7 patients Group B - asymptomatic with T4 count between 200 and 400 cellsmm3 7 patients Group C - asymptomatic with T4 count 200 cellsmm3 5 patients Group D - diagnosed as having AIDS related complex ARC or AIDS 7 patients All patients receive AZT After a minimum 2-week period of AZT patients receive an infusion of PEG IL-2 at 3 consecutive weekly intervals followed by a 3-week period of AZT alone This cycle 3 weeks of AZT and PEG IL-2 followed by 3 weeks of AZT alone is repeated a total of three times for a total of 18 weeks followed by 8 weeks of AZT alone
PER AMENDMENT Ten patients may qualify for one of two groups Group 1 - T4 count 200 - 400 cellsmm3 and meet all criteria established for Group B of the original protocol Group 2 - T4 count 200 cellsmm3 and meet all criteria established for Groups C and D of original protocol Patients will receive an amended schedule of PEG IL2 IV every other week for eight doses with dose escalation every other week for eight weeks permitted only in Group 2 patients who failed to show a 20 percent rise in T4 count at week 9 and who suffered no CNS or other adverse events at the lower dose
PER ADDITIONAL AMENDMENT Up to 10 additional patients may be treated at each dose of PEG IL2 on the biweekly schedule Patients who respond to treatment on the biweekly schedule are eligible for an additional 9 weeks at their current dose
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 |
|---|---|---|---|
| FDA 70A | None | None | None |
| CS-PG89-36 | None | None | None |