A Phase II Study of the Safety and Preliminary Evidence for Microbiologic and Immunologic Activity of Recombinant Human Interleukin 2 Study (rhIL-2;PROLEUKIN®) in HIV-non-infected Adults with Pulmonary Tuberculosis
Information:
DMID Protocol Number: 98-002
|
Type of Study |
Phase 2 Clinical Trial |
|---|---|
|
Design |
Randomized, placebo-control clinical trial |
|
Project Site |
Kampala, Uganda |
|
Sample Size |
110 subjects with smear positive/culture confirmed pulmonary active tuberculosis |
|
Population |
HIV-uninfected, male or female, adults 18-50 years old with newly diagnosed initial episodes of smear positive/culture confirmed pulmonary tuberculosis |
|
Study Period |
1999-2002 |
Goal of Study:
This study is designed to evaluate the safety, microbiologic and immunologic activity of rhIL-2 in HIV negative adults with pulmonary tuberculosis using a two-arm randomized, placebo-control design comparing 6 months of standard short course chemotherapy plus twice daily intradermal injections of 12.5µg rhIL-2 vs standard short course chemotherapy plus twice daily intradermal injections of placebo-excipient.
Objectives of Study:
- To determine rate of sputum culture conversion after 1 and 2 months on anti-tuberculosis treatment
- To determine safety of tolerability and toxicity of daily intradermal rhIL-2
- To determine immunologic response measured by peripheral blood cytokines, cytokine receptors and lymphocytes
The results of this completed study can be found in:
Gehring A, Rojas RE, Canaday DH, Lakey D, Harding CV, Boom WH. The Mycobacterium tuberculosis 19-Kilodalton Lipoprotein Inhibits Gamma Interferon-Regulated HLA-DR and Fc R1 on Human Macrophages through Toll-Like Receptor 2. Infect Immun 2003; 71:4487-4497. PMCID: PMC166015.