Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001005
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Study of Zidovudine Plus Interleukin-2 in HIV-Infected Patients Who Have No Symptoms of Infection But Who Have Tender Lymph Nodes
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Interleukin-2 Augmentation of Specific Anti-HIV Immune Responses Phase I Trial of the Combination of 3-Azido-3-Deoxythymidine Zidovudine and Recombinant Interleukin-2 in Patients With Asymptomatic HIV Infection Associated With Lymphadenopathy Walter Reed Stage II
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:
AMENDED To investigate whether subcutaneous SC injection of IL-2 produces biological responses which parallel those observed with IV dosing Original design To evaluate the short-term effects of combined administration of zidovudine AZT and increasing doses of recombinant interleukin-2 aldesleukin IL-2 in patients infected with HIV who have lymphadenopathy but who are otherwise asymptomatic no other symptoms The first phase of this clinical trial will establish maximum tolerated dose MTD How quickly the drugs get into the blood and how long they remain there pharmacokinetics will also be studied at each dose as well as the effect on HIV
Since AZT has no effect on cells that contain inactive virus latently infected cells and these cells may act as viral reservoirs that a second agent that can destroy these infected cells would be useful in combination with AZT The different activities of AZT and IL-2 as well as the non-overlapping nature of their mechanisms of action and toxicity increase the theoretical benefits of combining AZT a drug which has clinically significant activity in HIV-related disease but cannot eliminate infected cells with IL-2 a drug which may enhance anti-HIV immunity destroy chronically infected cells and allow immune recognition of latently infected cells
Since AZT has no effect on cells that contain inactive virus latently infected cells and these cells may act as viral reservoirs that a second agent that can destroy these infected cells would be useful in combination with AZT The different activities of AZT and IL-2 as well as the non-overlapping nature of their mechanisms of action and toxicity increase the theoretical benefits of combining AZT a drug which has clinically significant activity in HIV-related disease but cannot eliminate infected cells with IL-2 a drug which may enhance anti-HIV immunity destroy chronically infected cells and allow immune recognition of latently infected cells
Detailed Description:
Since AZT has no effect on cells that contain inactive virus latently infected cells and these cells may act as viral reservoirs that a second agent that can destroy these infected cells would be useful in combination with AZT The different activities of AZT and IL-2 as well as the non-overlapping nature of their mechanisms of action and toxicity increase the theoretical benefits of combining AZT a drug which has clinically significant activity in HIV-related disease but cannot eliminate infected cells with IL-2 a drug which may enhance anti-HIV immunity destroy chronically infected cells and allow immune recognition of latently infected cells
Five patients who have already received and tolerated oral AZT for at least 8 weeks continue their AZT treatment and at the same time receive IL-2 on a schedule of 5 days on the drug 2 days off the drug The IL-2 is administered by 30-minute intravenous IV infusion according to this schedule for 4 weeks The first week of IL-2 treatment is on an inpatient basis and the remaining 3 weeks are on an outpatient basis Toxicity is monitored every week Maximum tolerated dose MTD is defined as the maximum dose at which 3 out of 5 patients experience Grade 3 or above toxicity during the course of IL-2 administration A second cohort of five patients will receive IV IL-2 If the MTD is not reached five additional patients will receive IV IL-2 All five patients in a given cohort must complete a full 4-week course of IL-2 before subsequent patients are entered at the next higher dose level After IV dosing is completed at these three levels additional 5-patient cohorts receive subcutaneous SC IL-2 according to the same schedule Each patient is restricted to one dosage group Patients are treated and followed for a total of 24 weeks Patients receive ibuprofen for fever and chills
Five patients who have already received and tolerated oral AZT for at least 8 weeks continue their AZT treatment and at the same time receive IL-2 on a schedule of 5 days on the drug 2 days off the drug The IL-2 is administered by 30-minute intravenous IV infusion according to this schedule for 4 weeks The first week of IL-2 treatment is on an inpatient basis and the remaining 3 weeks are on an outpatient basis Toxicity is monitored every week Maximum tolerated dose MTD is defined as the maximum dose at which 3 out of 5 patients experience Grade 3 or above toxicity during the course of IL-2 administration A second cohort of five patients will receive IV IL-2 If the MTD is not reached five additional patients will receive IV IL-2 All five patients in a given cohort must complete a full 4-week course of IL-2 before subsequent patients are entered at the next higher dose level After IV dosing is completed at these three levels additional 5-patient cohorts receive subcutaneous SC IL-2 according to the same schedule Each patient is restricted to one dosage group Patients are treated and followed for a total of 24 weeks Patients receive ibuprofen for fever and chills
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 |
|---|---|---|---|
| 11017 | REGISTRY | DAIDS ES Registry Number | None |