Background: To evaluate clinical outcomes after either immediate or deferred initiation of antiretroviral therapy in\nHIV-1-infected patients, presenting late with pneumocystis pneumonia (PCP) or toxoplasma encephalitis (TE).\nMethods: Phase IV, multicenter, prospective, randomized open-label clinical trial. Patients were randomized into an\nimmediate therapy arm (starting antiretroviral therapy (ART) within 7 days after initiation of OI treatment) versus a\ndeferred arm (starting ART after completing the OI-therapy). All patients were followed for 24 weeks. The rates of clinical\nprogression (death, new or relapsing opportunistic infections (OI) and other grade 4 clinical endpoints) were compared,\nusing a combined primary endpoint. Secondary endpoints were hospitalization rates after completion of OI\ntreatment, incidence of immune reconstitution inflammatory syndrome (IRIS), virologic and immunological outcome,\nadherence to proteinase-inhibitor based antiretroviral therapy (ART) protocol and quality of life.\nResults: 61 patients (11 patients suffering TE, 50 with PCP) were enrolled. No differences between the two therapy\ngroups in all examined primary and secondary endpoints could be identified: immunological and virologic outcome\nwas similar in both groups, there was no significant difference in the incidence of IRIS (11 and 10 cases), furthermore 9\nevents (combined endpoint of death, new/relapsing OI and grade 4 events) occurred in each group.\nConclusions: In summary, this study supports the notion that immediate initiation of ART with a ritonavir-boosted\nproteinase-inhibitor and two nucleoside reverse transcriptase inhibitors is safe and has no negative effects on incidence\nof disease progression or IRIS, nor on immunological and virologic outcomes or on quality of life.
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