Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001763
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Subcutaneously Administered Interleukin-12 Therapy in HIV-Infected Patients With Disseminated Mycobacterium Avium Complex Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Subcutaneously Administered Interleukin-12 Therapy in HIV-Infected Patients With Disseminated Mycobacterium Avium Complex Infection
Status:
COMPLETED
Status Verified Date:
1999-04
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:
Disseminated infection with Mycobacteria avium complex MAC is one of the most common systemic bacterial infections in advanced stages of the acquired immunodeficiency syndrome AIDS Current therapy for disseminated MAC infection in HIV patients consists of multidrug chemotherapy regimens are often accompanied by toxicities and many patients become intolerant of one or more agents Macrolides are the essential component of successful therapy yet macrolide resistant strains are being recognized with increasing frequency Thus there is an interest in identifying additional therapeutic interventions for disseminated MAC in HIV-infected patients Interleukin-12 IL-12 is a central regulatory cytokine in cell-mediated immunity IL-12 enhances the cytolytic activity of cytotoxic T and NK cells and induces interferon-gamma IFN gamma production from T and NK cells This open-label Phase I study is designed to evaluate the safety and immunologicmicrobiologic effects of interleukin-12 administration in HIV-infected patients with concomitant disseminated Mycobacterium avium MAC infection Fifteen patients with documented disseminated MAC will be randomized to receive double-blinded placebo or escalating doses of IL-12 in addition to anti-MAC chemotherapy and standard anti-retroviral therapy for six weeks IL-12 will be administered subcutaneously with escalating doses every month over the dose range of 30 ngkg 100 ngkg and 300 ngkg or until an individual maximum tolerated dose IMTD is reached Should a patient receive 2 consecutive blood cultures negative for MAC during the course of the study at a lower dose then heshe will not be further dose escalated Those patients receiving placebo after 6 weeks will be crossed over to receive the full treatment course of IL-12 Each new dose or dose escalation will take place on an inpatient basis Once a patient is clinically stable at a dose the patient will be maintained at that dose as an outpatient for the remainder of the month Total IL-12 administration will not exceed 12 weeks or 24 total doses
Detailed Description:
Disseminated infection with Mycobacteria avium complex MAC is one of the most common systemic bacterial infections in advanced stages of the acquired immunodeficiency syndrome AIDS Current therapy for disseminated MAC infection in HIV patients consists of multidrug chemotherapy regimens are often accompanied by toxicities and many patients become intolerant of one or more agents Macrolides are the essential component of successful therapy yet macrolide resistant strains are being recognized with increasing frequency Thus there is an interest in identifying additional therapeutic interventions for disseminated MAC in HIV-infected patients Interleukin-12 IL-12 is a central regulatory cytokine in cell-mediated immunity IL-12 enhances the cytolytic activity of cytotoxic T and NK cells and induces interferon-gamma IFN gamma production from T and NK cells This open-label Phase I study is designed to evaluate the safety and immunologicmicrobiologic effects of interleukin-12 administration in HIV-infected patients with concomitant disseminated Mycobacterium avium MAC infection or localized MAC infection Fifteen patients with documented disseminated MAC will be randomized to receive double-blinded placebo or escalating doses of IL-12 in addition to anti-MAC chemotherapy and standard anti-retroviral therapy for six weeks IL-12 will be administered subcutaneously with escalating doses every month over the dose range of 30 ngkg 100 ngkg and 300 ngkg or until an individual maximum tolerated dose IMTD is reached Should a patient receive 2 consecutive blood cultures negative for MAC during the course of the study at a lower dose then heshe will not be further dose escalated Likewise patients with localized disease will not be further dose escalated if symptomsevidence of localized infection resolve as assessed by the principal investigator Those patients receiving placebo after 6 weeks will be crossed over to receive the full treatment course of IL-12 Each new dose or dose escalation will take place on an inpatient basis Once a patient is clinically stable at a dose the patient will be maintained at that dose as an outpatient for the remainder of the month Total IL-12 administration will not exceed 12 weeks or 24 total doses
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 |
|---|---|---|---|
| 98-I-0091 | None | None | None |