Effect of Adding Raltegravir to Intensify ART in Advanced HIV Disease in Africa: Results of the REALITY Trial

The risk for death after starting potent ART in sub-Saharan Africa for persons with advanced HIV disease remains high (about 10%). Initial treatment in that setting is complicated by the risk for the immune reconstitution inflammatory syndrome (IRIS). In this study, researchers evaluated whether adding raltegravir (a well-tolerated drug associated with rapid decrease in HIV levels) to standard three-drug ART would improve clinical outcomes. In a 2×2×2 factorial, open-label, parallel-group trial, treatment-naive HIV+ persons aged ≥5 years with CD4 counts <100 cells/mm³ from eight African HIV clinics were randomized 1:1 to receive standard triple-ART, +/−12 weeks of raltegravir, and followed for 48 weeks. From June 2013 to April 2015, 1805 pe…