Patients were stratified by CD4+ cell count and antiretroviral therapy use at base line (yes or no). The median CD4 count was 470 cells/mm3, and 50% of patients were on ART. Only efavirenz-based or nevirapine-based ART was allowed during IPT therapy.
In the experimental arm, patients were randomized to 4 weeks of rifapentine 450 mg for those less than 45 kg, or 600 mg for those 45 kg or higher, plus 300 mg isoniazid daily, plus 25 mg vitamin B6, followed by 32 weeks of observation.
Patients in the control arm received isoniazid and vitamin B6 daily for 36 weeks.
A total of 1,498 patients assigned to standard-of-care isoniazid and 1,488 assigned to 1HP were available for the efficacy analysis.