Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001407
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Interferon Gamma for Drug Resistant Tuberculosis
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Treatment of Multiply Drug Resistant Tuberculosis With Interferon Gamma A Phase III Dose Escalation Trial
Status:
COMPLETED
Status Verified Date:
2003-05
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:
This study will determine what dose of recombinant interferon-gamma is safe and effective for treating multiple drug-resistant tuberculosis Recombinant interferon-gamma is a genetically engineered form of a substance normally produced by the body and is used to boost immune function
Patients 5 years of age and older with multiply drug-resistant tuberculosis may be eligible for this study
Participants will be admitted to either the NIH Clinical Center in Bethesda Maryland the Texas Center for Infectious Diseases in San Antonio or the South Texas Hospital or Valley Baptist Hospital both in Harlingen Texas On admission patients will have a medical history physical examination blood and urine tests sputum culture X-rays pulmonary function tests and a computed tomography CT scan CT produces 3-dimensional images of body tissues and organs in small sections For the procedure the patient lies still on a table surrounded by the scanner
All patients will continue treatment with anti-tuberculosis antibiotics during and after the study period and may elect whether or not to take gamma interferon in addition to the antibiotic Five patients will receive only antibiotic treatment and 5 each will receive one of 3 doses 0025 005 or 01 milligrams per square meter of body surface area of interferon-gamma injected under the skin 3 times a week The patient or caregiver will be taught to give the injections which are similar to insulin injections for diabetes
Patients will be in isolation in the hospital from the start of therapy until sputum samples show no evidence of tuberculosis for 3 consecutive weeks Following that they will repeat the tests done on admission except CT during follow-up visits 1- to 2-day hospitalizations at 3 6 9 12 15 18 and 24 months after the start of therapy Patients taking interferon gamma will have blood drawn more frequently monthly for the first 6 months and patients with lung infection will have sputum samples collected more frequently-weekly for the first 3 months or until three consecutive negative samples are obtained and then monthly throughout the course of therapy Patients with lung infection will also have repeat CT scans at 6 and 12 months while on interferon gamma In one or two patients on the drug blood will be drawn frequently following one injection of gamma interferon just before the injection and again at 025 05 1 6 12 18 24 and 48 hours after it to see if a difference in blood levels of the drug can be detected
Patients 5 years of age and older with multiply drug-resistant tuberculosis may be eligible for this study
Participants will be admitted to either the NIH Clinical Center in Bethesda Maryland the Texas Center for Infectious Diseases in San Antonio or the South Texas Hospital or Valley Baptist Hospital both in Harlingen Texas On admission patients will have a medical history physical examination blood and urine tests sputum culture X-rays pulmonary function tests and a computed tomography CT scan CT produces 3-dimensional images of body tissues and organs in small sections For the procedure the patient lies still on a table surrounded by the scanner
All patients will continue treatment with anti-tuberculosis antibiotics during and after the study period and may elect whether or not to take gamma interferon in addition to the antibiotic Five patients will receive only antibiotic treatment and 5 each will receive one of 3 doses 0025 005 or 01 milligrams per square meter of body surface area of interferon-gamma injected under the skin 3 times a week The patient or caregiver will be taught to give the injections which are similar to insulin injections for diabetes
Patients will be in isolation in the hospital from the start of therapy until sputum samples show no evidence of tuberculosis for 3 consecutive weeks Following that they will repeat the tests done on admission except CT during follow-up visits 1- to 2-day hospitalizations at 3 6 9 12 15 18 and 24 months after the start of therapy Patients taking interferon gamma will have blood drawn more frequently monthly for the first 6 months and patients with lung infection will have sputum samples collected more frequently-weekly for the first 3 months or until three consecutive negative samples are obtained and then monthly throughout the course of therapy Patients with lung infection will also have repeat CT scans at 6 and 12 months while on interferon gamma In one or two patients on the drug blood will be drawn frequently following one injection of gamma interferon just before the injection and again at 025 05 1 6 12 18 24 and 48 hours after it to see if a difference in blood levels of the drug can be detected
Detailed Description:
This is a phase III controlled open label dose escalation study to determine the tolerance toxicity and clinical effect of the administration of interferon-gamma on the clinical condition and immune function of patients with multiply drug resistant M tuberculosis infections MDRTB The study drug interferon gamma will be administered subcutaneously three times a week at three dose levels 0025 mgm2 005 mgm2 01 mgm2 for one year in addition to anti-tuberculous medications as determined by in vitro sensitivities
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 |
|---|---|---|---|
| 94-I-0149 | None | None | None |