Pharmacokinetics and Safety of Double-dose Dolutegravir When Used With Rifapentine for HIV-associated Tuberculosis

A5406 hypothesizes that dolutegravir (DTG) 50 mg taken twice daily will provide adequate exposures to maintain viral suppression when dosed with rifapentine (RPT) 1200 mg for HIV-associated TB.

This is an open-label, single arm, phase II, multicenter PK study to investigate the effect of daily RPT 1200 mg on DTG exposure in participants with HIV-associated TB. Adults with HIV with newly diagnosed DS-TB who are not currently on ART will be recruited around the time of DS TB diagnosis. At study entry, the 2HPZM/2HPM regimen will be initiated for anti-tuberculosis (anti-TB) therapy and continued for 17 weeks.