Implementing antiretroviral therapy in resource constrained settings: The START Trial - (STarting AntiRetroviral Therapy) This is a two-armed randomized, open-label clinical trial evaluating whether the integration of HIV-1 care into existing tuberculosis care services is feasible and practical in resource poor settings. The primary objective is to assess the effectiveness of integrated tuberculosis and HIV-1 care provision versus sequential treatment of TB and HIV-1, by comparing the 18 month incidence of subsequent AIDS-defining illnesses or mortality among subjects with pulmonary TB co-infected with HIV-1. The study is condcuted in 2 phases. The first phase represents the duration of TB therapy. The second phase represents the period after completion of TB therapy. Subjects randomized into the integrated arm will receive antiretroviral therapy in conjunction with tuberculosis therapy upon randomization. Subjects randomiszed to the sequential arm will complete tuberculosis treatment and then start antiretroviral therapy after approximately 6 months of tuberculosis treatment. Since tuberculosis is the commonest presenting illness in AIDS patients in much of the developing world, the integration of HIV and tuberculosis care is an efficient method of identifying those in greatest need of antiretroviral therapy. 720 eligible participants, who are co-infected with HIV and tuberculosis, will be randomised to either the integrated arm, where both anti-tuberculosis and antiretroviral drugs are provided through directly observed therapy supplemented with an adherence counselling program,

The START Team: or the sequential arm where they receive standard anti-tuberculosis treatment. Upon completion of tuberculosis therapy, the participants in both study arms are provided ongoing HIV care, which includes self-administered anti-retroviral therapy. The findings of this study could have a major impact in South Africa and other countries in the developing world as it would provide an affordable and effective strategy for the successful implementation of antiretroviral therapy.