Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000949
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
A Study to Evaluate the Effects of Giving Proleukin rIL-2 to HIV-Positive Patients With CD4 Counts Greater Than 300 Cellsmm3
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Open-Label Study of the Impact of Two Doses of Subcutaneous Recombinant IL-2 Proleukin on Viral Burden and CD4 Cell Count in Patients With HIV-1 Infection and CD4 Cell Counts Greater Than or Equal to 300mm3
Status:
COMPLETED
Status Verified Date:
2021-10
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:
The purpose of this study is to examine how rIL-2 affects HIV-positive patients with CD4 counts over 300 cellsmm3 who are on anti-HIV drug therapy The drug rIL-2 has been shown to increase CD4 cell counts which help the body fight off HIV
There is strong evidence that rIL-2 increases CD4 cell counts cells of the immune system that fight infection This study examines the effect of 2 different amounts of rIL-2 on CD4 cell count and the amount of HIV in the blood viral burden
There is strong evidence that rIL-2 increases CD4 cell counts cells of the immune system that fight infection This study examines the effect of 2 different amounts of rIL-2 on CD4 cell count and the amount of HIV in the blood viral burden
Detailed Description:
There is substantial evidence that rIL-2 increases CD4 cell count Whether or not rIL-2 delays progression to AIDS and extends survival is currently unknown such clinical benefits of rIL-2 can only be established in a large long-term randomized trial This study examines the effect of two different rIL-2 doses on HIV viral burden and CD4 cell count and provides additional information on optimal dosing safety and antiviral activity of rIL-2
Patients are randomized to receive one of two subcutaneous sc doses of recombinant rIL-2 or no rIL-2 Those patients who take rIL-2 initially receive three courses of treatment For this study a course is defined as eight calendar weeks including the five-day period of sc rIL-2 administration Additional courses are given no more frequently than every 6 weeks in order to maintain a CD4 count of at least twice its baseline level or at least 1000 cellsmm3 Follow-up will continue for all patients until a common closing date of 12 months following enrollment of the last patient
Patients are randomized to receive one of two subcutaneous sc doses of recombinant rIL-2 or no rIL-2 Those patients who take rIL-2 initially receive three courses of treatment For this study a course is defined as eight calendar weeks including the five-day period of sc rIL-2 administration Additional courses are given no more frequently than every 6 weeks in order to maintain a CD4 count of at least twice its baseline level or at least 1000 cellsmm3 Follow-up will continue for all patients until a common closing date of 12 months following enrollment of the last patient
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11615 | REGISTRY | DAIDS ES Registry ID | None |