IL-2 (Proleukin®) - DMID 98-002

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


DMID Protocol Number: 98-002

Type of Study

Phase 2 Clinical Trial


Randomized, placebo-control clinical trial

Project Site

Kampala, Uganda

Sample Size

110 subjects with smear positive/culture confirmed pulmonary active tuberculosis


HIV-uninfected, male or female, adults 18-50 years old with newly diagnosed initial episodes of smear positive/culture confirmed pulmonary tuberculosis

Study Period


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:

  1. To determine rate of sputum culture conversion after 1 and 2 months on anti-tuberculosis treatment
  2. To determine safety of tolerability and toxicity of daily intradermal rhIL-2
  3. 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.