Study design and participants
allergy, psychiatric, substance abuse
ALLERGY
RADIANT-TB was a phase 2b, randomised, double-blind, non-comparative, placebo-controlled trial at a single clinical site in Khayelitsha, Cape Town, South Africa. National regulatory and ethical approval (Human Research Ethics Committee of the University of Cape Town) were obtained before commencing the study. The detailed study protocol plan has been published online.Patients were referred to the study from three primary care clinics in Khayelitsha. Inclusion criteria were age older than 18 years, seropositivity for HIV-1, plasma HIV-1 RNA greater than 1000 copies per mL, CD4 count greater than 200 cells per μL (subsequently changed to more than 100 cells per μL), ART naivety or first-line ART interruption (with ART duration <6 months or HIV-1 RNA <50 copies per mL <6 months before interruption), and being on rifampicin-based antituberculosis therapy for less than 3 months. Women of childbearing potential were placed on appropriate contraceptives for the duration of the study. Among the exclusion criteria were alanine aminotransferase more than three times the upper limit of normal, allergy or intolerance to one of the drugs in the regimen, and an active psychiatric condition or substance abuse judged likely to affect adherence. All participants gave written informed consent (in English or isiXhosa) before enrolment. Sex was self-reported, selecting either a male or female option.