SAEFRIF clinical trial:
The “Safety and Efficacy of High Dose Rifampicin in Tuberculosis (TB)-HIV Co-infected Patients on Efavirenz- or Dolutegravir-based Antiretroviral Therapy” (SAEFRIF) clinical trial (NCT03982277) was performed at the Infectious Disease Institute at Makerere University, Uganda. The data presented in this paper provide preliminary data on liver safety from 64 trial participants. A full report on pre-defined study end-points will be provided on trial completion. This trial was approved by a local research and ethics committee, the National Drug Authority and the Uganda National Council for Science and Technology.
Inclusion criteria were HIV-infected patients aged ≥18 years who were due to initiate rifampicin-containing therapy for newly diagnosed active TB, and were either already taking or planning to start efavirenz (EFV)-based or dolutegravir (DTG)-based ART. Exclusion criteria were patients who have rifampicin resistant TB, pregnant women, women of reproductive age on DTG who decline the use of effective contraceptive, patients with liver disease, ALT > x5 ULN or glomerular filtration rate < 50 ml/min.
The trial protocol is described in Nabisere et al. , 2020. Patients were randomised to one of 4 arms of the trial for the first 2 months of treatment, either the standard (10 mg/kg) or high dose (35 mg/kg) rifampicin alongside standard doses of the other first line TB drugs and either EFV- or DTG-based ART. Baseline blood samples (serum) were collected at baseline and weeks 2, 4, 6, and 8 of treatment.