A5349: TBTC S31

TBTC Study 31/ ACTG A5349

Rifapentine-Containing, Treatment-Shortening Regimens for Pulmonary Tuberculosis: A Randomized, Open-label, Controlled, Phase 3 Clinical Trial

Treatment Category: Tuberculosis   

Study Description
Tuberculosis (TB) is an important global health problem. The World Health Organization estimated that TB caused 9 million people to fall sick and 1.5 million deaths in 2013. TB is the leading cause of death among people with HIV. There are medicines and regimens to treat TB, but the current standard treatment is long and complicated. The length and complication of the current standard TB treatment regimen makes it difficult for many people with TB to finish a full course of therapy, and therefore it is a major obstacle to eliminating TB. Incomplete TB treatment can lead to increased illness and death, longer periods of infectiousness and transmission to others, and development of drug resistance. Therefore, developing shorter TB treatment regimens that are safe and well tolerated by participants could improve individual and public health. 

Although the United States has falling rates of tuberculosis (TB), which can be attributed to strong public health programs that is not the case in many other parts of the world.  For example, countries such as South Africa, Zimbabwe and Kenya experience TB rates of up to 300-times greater than the United States. These alarmingly high rates of active TB disease result in almost one-third of all HIV/AIDS-related deaths  Currently, treatment for TB takes at least six months and it is not uncommon for participants to stop therapy once they feel better prior to completing the treatment course.  This increases the risk of relapse and/or development of resistance to available TB drug regimens. It is clear, that by expediting TB treatments, enormous benefits will be reaped by not only participants, but also health care systems.  With that in mind, the ACTG Network has partnered with the Tuberculosis Trials Consortium (TBTC) to launch the latest treatment shortening regimen study, TBTC Study 31/ACTG A5349: Rifapentine-containing Treatment Shortening Regimens for Pulmonary Tuberculosis: A randomized, open-label, controlled, phase 3 clinical trial.

“Finding effective, shorter TB treatment regimens is the highest scientific priority for the ACTG Network’s TB Transformative Science Group (TSG),” said TB TSG Chair Richard Chaisson, MD, Professor of Medicine, Epidemiology and International Health, and Director, Centers for AIDS Research and Tuberculosis Research, Johns Hopkins University.  “Our collaboration with the TBTC will allow us to leverage our participant populations and resources with theirs, increasing the speed with which A5349 can be completed and answers obtained.”

More information about TBTC Study 31/ACTG A5349

Why is this study being done?
We are doing this study to find out if taking higher doses of a drug called rifapentine, alongside other TB drugs, for 4 months works as well as the standard 6-month TB treatment.

Who can join?
To enroll in this study, participants must meet all of the following criteria: 

  • Suspected pulmonary TB (TB in the lungs)
  • Age 12 years or older
  • A verifiable address or residence that is readily accessible for visiting
  • For all women, a negative pregnancy test
  • Individuals with HIV must have a CD4 T-cell count greater than or equal to 100 cells/mm3
  • Laboratory measurements involving blood draws done at or within 14 days prior to screening
  • Written informed consent

What do I need to do in the study?
Participants will be randomly assigned (by chance) to one of the three study arms. Depending on which arm you are assigned to, you will be taking the study drugs either for 17 weeks or 36 weeks. You will be on study for approximately 18 weeks.

What treatments or drugs are involved with this study?

Arm 1 (control regimen):

  • 8 weeks of daily treatment with rifampin, isoniazid, pyrazinamide, and ethambutol, followed by
  • 18 weeks of daily treatment with rifampin and isoniazid

Arm 2 (investigational regimen):

  • 8 weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and ethambutol, followed by
  • 9 weeks of daily treatment with rifapentine and isoniazid

Arm 3 (investigational regimen):

  • 8 weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and moxifloxacin, followed by
  • 9 weeks of daily treatment with rifapentine, isoniazid, and moxifloxacin

Participating ACTG Sites:

Study Status: