Clinical Trials | Tuberculosis Research Unit

Research Overview

TBRU\x92s mission for clinical trials includes potential interventions such as new vaccines, prophylactics or therapeutic regimens, using developed surrogate markers of M. tuberculosis infection, tuberculosis progression and/or host protection to validate the usefulness of these markers in clinical trials and evaluate safety, reactogenicity and efficacy of new regimens. This includes Phase I, and II clinical trials using potential new surrogate markers, evaluation of new assays for the rapid diagnosis of tuberculosis and drug susceptibility testing, and developing and implementing strategies for long-term follow-up. In addition investigators work closely with the trials sites and staff to also support TBRU pilot immunological and microbiological studies focusing on novel surrogate markers of response to TB treatment and correlates of protective immunity.

TBRU currently has three primary clinical trial sites located at Mulago Hospital, Makerere University, Kampala, the South African Tuberculosis Vaccine Initiative, University of Cape Town, Cape Town, South Africa (including the SATVI Brewelskloof Tuberculosis Hospital, Worcester, South Africa), and TASK Applied Sciences, Cape Town, South Africa.

Organization and Operation

New clinical trials are identified, considered, and developed with the Scientific Working Groups and the NIH sponsor. Dr. Henry Boom and Dr. John L. Johnson, at CWRU lead these new initiatives and development as indicated for TBRU clinical trials. Once a specific trial is determined for TBRU, a protocol team of investigators and staff from CWRU, the clinical field site, as well as additional TBRU investigators are convened for development and implementation of the final trial protocol. Clinical trials protocol teams work closely with the sponsor office during the development period and thereafter to assure all regulatory issues are appropriately addressed for these new studies.

Active and completed Clinical Trials

Below is a listing of active and completed clinical trials conducted by TBRU. For further details on these trials, please click the links provided in the short study title.

Click on a column header to sort by that column

Protocol Number	Study Title	Short Study Title	Project Site	Status
DMID 11-0006	Randomized, Open Label, Multiple Dose Phase 2a Study of the Early Bactericidal Activity of AZD5847 in Adults with Pulmonary Tuberculosis	AZD5847	South Africa	Active
DMID 08-0023	A Pilot Study to Evaluate Nucleic Acid Amplification and Other Tests to Monitor the Effectiveness of Tuberculosis Treatment	NAA2M	Uganda	Completed
DMID 07-0083	Phase I Study of Whether Preclearance of Latent M. tuberculosis (MTB) Infection With Isoniazid (INH) Enhances Specific Immune Responses to MTB Following Subsequent BCG Revaccination in Healthy, HIV-uninfected, Tuberculin Skin Test Positive Adults	BCG	South Africa	Active
DMID 01-553	Randomized, Open Label, Multiple Dose Phase I Study of the Early Bactericidal Activity of Linezolid, Gatifloxacin, Levofloxacin and Moxifloxacin in HIV-non-infected Adults with Initial Episodes of Smear-Positive Pulmonary Tuberculosis	EBA	Brazil	Completed
DMID 01-009	A Prospective Study of Shortening the Duration of Standard Short Course Chemotherapy from 6 Months to 4 Months in HIV-non-infected Patients with Fully Drug-Susceptible, Non-cavitary Pulmonary Tuberculosis with Negative Sputum Cultures after 2 Months of Anti-TB Treatment	TX	Brazil, Philippines, Uganda	Completed
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	IL2	Uganda	Completed
DMID 97-012	An Open Label Multiple Doses Study of the Safety and the Early Bactericidal Activity of KRM-1648 in the Treatment of Newly Diagnosed Adults with Smear-Positive Pulmonary Tuberculosis	KRM	Brazil	Completed
DMID 94-120	Safety and Preliminary Evidence for Microbiologic and Immunologic Activity of Heat-Killed Mycobacterium vaccaeImmunotherapeutic Agent as an Adjunct to Combination Chemotherapy for the Initial Treatment of Pulmonary Tuberculosis in HIV-non-infected Adults in Uganda	M. vaccae	Uganda	Completed

Further information on the following completed studies can be found at the U.S. government clinical trials site as follows; or can be searched by protocol number at http://clinicaltrials.gov.