Randomized Clinical Trial Comparing 4RIF vs. 9INH for LTBI Treatment-effectiveness
Status:
Completed
Trial end date:
2017-04-01
Target enrollment:
Participant gender:
Summary
On a global scale, tuberculosis (TB) is the single most important infectious cause of
morbidity and mortality. The World Health Organization has estimated that one-third of the
entire world's population carries latent TB infection. A key TB control strategy is therapy
of latent TB infection (LTBI). The current standard regimen is 9 months of Isoniazid (9INH).
This regimen has excellent efficacy if taken regularly, but its effectiveness is
substantially reduced by poor compliance. Serious side effects, such as hepato-toxicity can
occur. Three shorter alternatives have been recommended: 6 months INH (6INH), 2 months
Rifampin - Pyrazinamide (2RIF-PZA) and 4 months Rifampin (4RIF). The regimen of 6INH is less
efficacious than 9INH, while 2RIF-PZA has been largely abandoned because of serious toxicity.
Based on some evidence in treatment of LTBI, and extrapolating from extensive experience with
treatment of active TB, it is believed that 4RIF has similar efficacy as 9INH. Therefore, the
investigators are initiating the first multi-site international randomized trial that will
compare the effectiveness of 4RIF and 9INH in preventing active tuberculosis.