Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000986
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of Interleukin-2 Plus Zidovudine in Patients With AIDS or AIDS Related Complex
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Safety Tolerance and Immunological Study of a Combination of Recombinant Interleukin 2 and Zidovudine in Patients With AIDS or AIDS Related Complex
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:
To test the safety and tolerance of three different doses of recombinant human interleukin 2 aldesleukin IL-2 when it is given for five consecutive days to patients with AIDS or AIDS related complex ARC who have also received zidovudine AZT for at least 6 weeks just before beginning the IL-2 treatment
AZT is an antiviral drug which has been shown to be beneficial in some patients with AIDS IL-2 is a substance found naturally in the body that boosts the bodys immune response to invading organisms and tumor cells These two drugs when administered together may have a mutually helpful effect in treating AIDS patients but before this effect can be studied it is important to understand the proper dose and any side effects that may occur when these drugs are used together The study will show how much AZT and IL-2 patients can safely take at the same time and how the two drugs will interact with each other
AZT is an antiviral drug which has been shown to be beneficial in some patients with AIDS IL-2 is a substance found naturally in the body that boosts the bodys immune response to invading organisms and tumor cells These two drugs when administered together may have a mutually helpful effect in treating AIDS patients but before this effect can be studied it is important to understand the proper dose and any side effects that may occur when these drugs are used together The study will show how much AZT and IL-2 patients can safely take at the same time and how the two drugs will interact with each other
Detailed Description:
AZT is an antiviral drug which has been shown to be beneficial in some patients with AIDS IL-2 is a substance found naturally in the body that boosts the bodys immune response to invading organisms and tumor cells These two drugs when administered together may have a mutually helpful effect in treating AIDS patients but before this effect can be studied it is important to understand the proper dose and any side effects that may occur when these drugs are used together The study will show how much AZT and IL-2 patients can safely take at the same time and how the two drugs will interact with each other
AMENDED Note that the dose of AZT changed 900214 to reflect new dose recommendations Original design Six weeks before beginning treatment with IL-2 patients are given AZT daily There are three patient groups one for each dose level of IL-2 On the first day of treatment with the two drugs together patients are admitted to Presbyterian University Hospital where AZT is administered orally every 4 hours and IL-2 is given once a day as a single injection under the skin Clinical and laboratory safety data from the first two patients enrolled in each treatment group will be analyzed prior to enrolling additional patients in each group All patients are expected to stay in the hospital for at least 5 days and some may stay longer if serious side effects develop AZT treatment will continue after the patient leaves the hospital for an additional 10 weeks Follow-up visits are scheduled for days 6 8 and 15 for safety immunologic and virologic evaluations Thereafter patients are followed by telephone interview every other week and come into the clinic if a change in health is reported At weeks 10 and 20 patients are also evaluated in a follow-up clinic visit
AMENDED Note that the dose of AZT changed 900214 to reflect new dose recommendations Original design Six weeks before beginning treatment with IL-2 patients are given AZT daily There are three patient groups one for each dose level of IL-2 On the first day of treatment with the two drugs together patients are admitted to Presbyterian University Hospital where AZT is administered orally every 4 hours and IL-2 is given once a day as a single injection under the skin Clinical and laboratory safety data from the first two patients enrolled in each treatment group will be analyzed prior to enrolling additional patients in each group All patients are expected to stay in the hospital for at least 5 days and some may stay longer if serious side effects develop AZT treatment will continue after the patient leaves the hospital for an additional 10 weeks Follow-up visits are scheduled for days 6 8 and 15 for safety immunologic and virologic evaluations Thereafter patients are followed by telephone interview every other week and come into the clinic if a change in health is reported At weeks 10 and 20 patients are also evaluated in a follow-up clinic visit
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 |
|---|---|---|---|
| 11041 | REGISTRY | DAIDS ES Registry Number | None |