The SAPIT trial provides essential evidence on risks and benefits of integrated and sequential treatment of HIV and tuberculosis.

Abstract

Boulle et al.(1) queried whether a clinical trial was needed to provide the evidence for the mortality benefits of antiretroviral therapy (ART) initiation during tuberculosis (TB) treatment. While several experts, including foremost TB-HIV scientists from South Africa (2) and the USA,(3) senior World Health Organization (WHO) (4) and UNAIDS (5) officials at the time the study was initiated, the 2003 WHO AIDS Treatment Guidelines Committee Chair (3), the Chair of the Ethics Committee (6) and the researchers,(7) have previously addressed the points raised, the SAPIT (Starting Antiretroviral Therapy at Three Points in Tuberculosis) research team welcomes the opportunity also to address the comments. We hold Boulle and his colleagues in high regard and appreciate their contributions to the field of HIV and tuberculosis co-infection. More importantly, we share with them the common goal of rigorously and relentlessly seeking answers to critically important research questions as we confront the devastating dual AIDS and tuberculosis epidemics. The SAPIT trial,(8) which was developed in 2004, set out to assess whether integrating tuberculosis and AIDS treatment would lead to improved outcomes compared with the widely practised approach of treating them sequentially. The trial’s Safety Monitoring Committee halted the sequential treatment arm in September 2008 because of a 56% lower mortality rate in the integrated treatment arm. We systematically address the queries on equipoise and standard of care.