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 (0.025, 0.05 or 0.1 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 0.25, 0.5, 1, 6, 12, 18, 24 and 48 hours
after it) to see if a difference in blood levels of the drug can be detected.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)