Interleukin-12 in the Treatment of Severe Nontuberculous Mycobacterial Infections
Status:
Completed
Trial end date:
2003-07-01
Target enrollment:
Participant gender:
Summary
This study will test the safety and effectiveness of a drug called interleukin-12 (IL-12) in
fighting severe infectious (other than tuberculosis) caused by a group of bacteria called
mycobacteria. IL-12 is similar to a substance the body produces naturally to strengthen
immune function (infection-fighting ability). It works by stimulating white blood cells to
increase production of a chemical called interferon gamma, which can improve or cure
mycobacterial infections in some patients.
In previous studies, IL-12 has improved immune function against mycobacteria in test tube
experiments and in mice. A recent study of three patients with mycobacterial infections
treated with the drug showed encouraging results. The drug has also been studied more
extensively in patients with cancer, HIV infection and hepatitis C.
Patients in this study will receive IL-12 injections under the skin twice a week for one
year. They will be taught how to self-administer the drug, but a home care nurse or a
physician may also give the injections. The drug dosage will be increased each week to
determine the safest and most effective dose for fighting this infection. If intolerable side
effects develop at a certain dose, the previous dose level will be used for the next
injection. That dose will then be used for the rest of the study, unless unacceptable side
effects develop at that level, in which case the dose will again be lowered. Patients will
receive an antibiotic against mycobacteria.
Physical examinations and blood and urine tests will be done once a month for at least the
first year and then every 3 months the following year to evaluate kidney, liver, and immune
function. The first evaluation-at the start of the study-is done on an inpatient basis.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)