Immediate ART in Subjects with Opportunistic Diseases

Sample size was calculated using formula, of difference in proportions formula using a beta of 0.1, alpha of 0.05 and an expected difference in mortality of 20%, The sample size is 225 subjects in each group. Informed consent will be obtained. Patients will be allocated to each group (iART or cART) after randomization stratified by the CD4+ T cell count (less or more than 50 cells/mm3). Plasma viral load and CD4+ T cell count will be measured at study entry and at weeks 2, 4, 12, 24 and 48 after ART initiation. Clinical outcomes will be: mortality at 4, 12, 24, and 48 weeks, length of hospitalization (measured in days), clinical and microbiological cure of the opportunistic disease, incidence and severity of immune reconstitution of inflammatory syndrome (IRIS), and adverse drug reactions and interactions. Once 50% of the sample size has completed 30 days of follow‐up, a preliminary analysis will be conducted to assess safety and efficacy of iART; if differences in the mortality are observed, the study will be terminated.