Ignite Creation Date:
2024-05-05 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001036
Status:
COMPLETED
Last Update Posted:
2008-07-30
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of a Type of Interleukin-2 Plus Zidovudine Plus Thymosin in HIV-Positive Patients With and Without Symptoms of Infection
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 and Thymosin Alpha 1 in HIV-Positive Asymptomatic and Symptomatic Individuals
Status:
COMPLETED
Status Verified Date:
1996-10
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 thymosin alpha 1 given twice weekly in a regimen of daily oral zidovudine AZT and biweekly polyethylene glycolated interleukin-2 PEG IL-2 To determine the effect of thymosin alpha 1 and PEG IL-2 in combination with AZT on immunologic and pharmacokinetic markers
AIDS is characterized by diminished T helper cell number and function Thymosin alpha 1 appears to both increase IL-2 receptors on lymphocytes in vitro and enhance lymphocyte maturation in vivo thus the drug may further enhance the CD4 T cell levels in patients receiving AZT and PEG IL-2
AIDS is characterized by diminished T helper cell number and function Thymosin alpha 1 appears to both increase IL-2 receptors on lymphocytes in vitro and enhance lymphocyte maturation in vivo thus the drug may further enhance the CD4 T cell levels in patients receiving AZT and PEG IL-2
Detailed Description:
AIDS is characterized by diminished T helper cell number and function Thymosin alpha 1 appears to both increase IL-2 receptors on lymphocytes in vitro and enhance lymphocyte maturation in vivo thus the drug may further enhance the CD4 T cell levels in patients receiving AZT and PEG IL-2
Patients are stabilized on oral AZT daily for 8 weeks and then begin receiving bolus infusions of PEG IL-2 every other week for at least four doses Thymosin alpha 1 given SC is then added to this regimen twice weekly for 4 weeks If no significant toxicity occurs thymosin alpha 1 is increased to and administered along with scheduled doses of PEG IL-2 for an additional 8 weeks
Patients are stabilized on oral AZT daily for 8 weeks and then begin receiving bolus infusions of PEG IL-2 every other week for at least four doses Thymosin alpha 1 given SC is then added to this regimen twice weekly for 4 weeks If no significant toxicity occurs thymosin alpha 1 is increased to and administered along with scheduled doses of PEG IL-2 for an additional 8 weeks
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?: