Antiretroviral therapy: Phase III data

Researchers at the hospital system and colleagues reported data from the open-label, Cambodian Phase III CAMELIA trial in 661 patients showing that initiating ART 2 weeks after the start of TB treatment significantly improved survival, the primary endpoint, at a median follow-up of 25 months compared to initiating ART 8 weeks after the start of TB treatment. Specifically, the rate of death in the earlier ART treatment arm was 18% vs. 27% in the later ART treatment arm (p=0.006). The trial enrolled HIV-infected patients with a baseline CD4+ T cell count of <=200 cells/mm 3 who had not been previously exposed to antiretroviral drugs and who had newly diagnosed TB. Patients were randomized to receive ART starting 2 or 8 weeks after beginning a standard 6-month TB regimen consisting of isoniazid, rifampicin, ethambutol and pyrazinamide for 2 months followed by isoniazid and rifampicin for 4 months. The French National Agency for Research on AIDS and Viral Hepatitis and NIH's National Institute of Allergy and Infectious Diseases (NIAID) sponsored the trial. Data were published in the New England Journal of Medicine. ...