Clinical Trials - TB - Completed studies

Completed TB studies

The clinical trials that CHRU has completed in TB are listed below:

NCT00864383

Protocol number title: A randomized placebo-controlled double-blind trial comparing two treatment shortening regimens with the standard TB regimen for the treatment of adults with pulmonary tuberculosis.

REMoxTB was a global Phase 3 clinical trial to determine whether a moxifloxacin-containing TB treatmentregimen could reduce the time needed to treat drug-sensitive TB patients from 6 months or longer to 4 months. It was the first regulatory study to confirm the safety of daily moxifloxacin over four months of therapy. Its safety, combined with its activity against TB, supports the continued clinical testing of moxifloxacin as a component of other, novel regimens, such as PaMZ. It was thought that there were regional differences in patients’ response to treatment across the world. The trial demonstrated no evidence that different populations respond differently to treatment.

PI Interventional / Observational Closed/ Ongoing Start/
end date
Network Funders/ sponsors
Prof Sanne Interventional Closed 2010/2013 N/A TB Alliance

NCT00108862

Protocol number title: ART Timing in New TB Patients

This study sought to establish if, in patients starting treatment for TB, the immediate initiation of ART (within 2 weeks) could reduce mortality and morbidity, compared to the early initiation of ART (8-12 weeks). Key conclusions include:

  • Both immediate and early ART strategies are safe and do not jeopardize CD4 or viral suppression rates
  • In patients with CD4 count of less than 50, ART should be started within 2 weeks
  • Delays increase AIDS and death
  • TB-Immune Reconstitution Inflammatory Syndrome (IRIS) is more common in those receiving immediate ART but does not increase mortality.
  • Implementation this study’s findings should be a high priority in HIV and TB programs and will require coordination with hospital and outpatient programs.
PI Interventional / Observational Closed/ Ongoing Start/
end date
Network Funders/ sponsors
Prof Sanne, Dr Ive and Dr Firnhaber Interventional Closed 2006/ 2010 AIDS Clinical Trials Group (ACTG) National Institutes of Health (NIH)

NCT00865826

Protocol number title:  Sensitivity and Specificity of Mycobacterium Tuberculosis Screening and Diagnostics in HIV-Infected Individuals

PI Interventional / Observational Closed/ Ongoing Start/
end date
Network Funders/ sponsors
Dr Ive Observational Closed 2009/2011 AIDS Clinical Trials Group (ACTG) National Institutes of Health (NIH))

NCT00959088

Protocol number title: Faster identification of TB and RIF Resistance in non-US HIV-Infected TB Suspects

PI Interventional / Observational Closed/ Ongoing Start/
end date
Network Funders/ sponsors
Dr Sanne/Dr Firnhaber Observational Closed 2009/2012 AIDS Clinical Trials Group (ACTG) National Institutes of Health (NIH))

NCT01380080

Protocol number title: Reducing Early Mortality and Early Morbidity by Empiric Tuberculosis Treatment Regimens

PI Interventional / Observational Closed/ Ongoing Start/
end date
Network Funders/ sponsors
Dr Badal-Faesen Interventional Closed 2011/2016 AIDS Clinical Trials Group (ACTG) National Institutes of Health (NIH))

NCT01404312

Protocol number title: Short-course rifapentine/isoniazid for treatment of latent TB in HIV-infected individuals.

This randomized, open-label trial showed that a 1-month regimen of daily rifapentine plus isoniazid (also known as “1HP”) was non-inferior to daily isoniazid for nine months as TPT in HIV-positive individuals. The 1-month regimen was also found to be safe, with fewer adverse events and a better completion rate than the traditional 9-month regimen. This study provides strong evidence that national programs should consider the 1-month regimen used in this study as an option for TPT in people living with HIV. However, cost of the 1HP regimen may be a barrier and there still remain gaps in evidence around its use with pregnant and breastfeeding women, children, and those on a dolutegravir-based regimen.

PI Interventional / Observational Closed/ Ongoing Start/
end date
Network Funders/ sponsors
Dr Mwelase Interventional Closed 2012 –2018 AIDS Clinical Trials Group (ACTG) National Institutes of Health (NIH))

NCT01587469

Protocol number title: Xpert MTB/RIF vs Standard TB Diagnostics in TB Suspects.

CHRU took part in Study A5295 which lead to FDA approval of the expanded indication for the use of Xpert MTB/RIF. The data gathered from this study contribute to more rapid and reliable TB testing. Xpert testing has been incorporated into several ongoing clinical trials conducted by the ACTG Network, aimed at making TB treatment shorter and more effective.

PI Interventional / Observational Closed/ Ongoing Start/
end date
Network Funders/ sponsors
Dr Firnhaber Observational Closed 2012/2014 AIDS Clinical Trials Group (ACTG) National Institutes of Health (NIH))

NCT01924286

Protocol number title: TB –related Immune Reconstitution Syndrome in HIV infected South Africans.

PI Interventional / Observational Closed/ Ongoing Start/
end date
Network Funders/ sponsors
Dr Conradie Interventional Closed 2007/2008 Wistar Institute National Institutes of Health (NIH))

NCT01498419

Protocol number title: A Phase II Open-Label Partially Randomized Trial to Evaluate the Efficacy, Safety and Tolerability of the combination of moxifloxacin plus PA-824 plus pyrazinamide after 8 weeks of treatment in Adult Patients with Newly Diagnosed Drug-Sensitive or Multi Drug-Resistant, Smear-Positive Pulmonary Tuberculosis.

PI Interventional / Observational Closed/ Ongoing Start/
end date
Network Funders/ sponsors
Dr Ive Interventional Closed 13 Apr 2012/31 Dec 2013 TB Alliance Global Alliance for TB Drug Development

NCT02193776

Protocol number title: A Phase 2 Open‐Label Partially Randomized Trial to Evaluate the Efficacy, Safety and Tolerability of combinations of bedaquiline, moxifloxacin, PA‐824 and pyrazinamide during 8 weeks of treatment in Adult Subjects with Newly Diagnosed Drug‐Sensitive or Multi Drug‐Resistant, Smear‐Positive Pulmonary Tuberculosis.

PI Interventional / Observational Closed/ Ongoing Start/
end date
Network Funders/ sponsors
Dr Rassool (DS TB) Interventional Closed 2014 TB Alliance Global Alliance for TB Drug Development

NCT02342886

Protocol number title: A Phase 3 Open-Label Partially Randomized Trial to Evaluate the Efficacy, Safety and Tolerability of the Combination of Moxifloxacin plus PA-824 plus Pyrazinamide after 4 and 6 months of Treatment in Adult Subjects with Drug-Sensitive Smear-Positive Pulmonary Tuberculosis and after 6 months of Treatment in Adult Subjects with Multi-Drug Resistant, Smear-Positive Pulmonary Tuberculosis

PI Interventional / Observational Closed/ Ongoing Start/
end date
Network Funders/ sponsors
Dr Conradie (MDR TB) Interventional Closed 2016 TB Alliance Global Alliance for TB Drug Development

NCT01785186

Protocol number title: A multiple arm, multiple stage (MAMS), phase 2, open label, randomized, controlled clinical trial to evaluate four treatment regimens including two doses of SQ109, an increased dose of rifampicin, and moxifloxacin in adult subjects with newly diagnosed, smear-positive pulmonary tuberculosis.

PI Interventional / Observational Closed/ Ongoing Start/
end date
Network Funders/ sponsors
Dr Mellet Interventional Closed 2014 TB Alliance Michael Hoelscher/
Sequella, Inc./
European and Developing Countries Clinical Trials Partnership (EDCTP) and others

NCT03568383

Protocol number title: Study of MDR TB Cases and Their Household Contacts: Operational Feasibility to Inform PHOENIx Trial Design.

PI Interventional / Observational Closed/ Ongoing Start/
end date
Network Funders/ sponsors
Dr Conradie Interventional Observational 2013 AIDS Clinical Trials Group (ACTG) National Institutes of Health (NIH))