In this open, non-inferiority trial in three centres in Uganda and one in Zimbabwe, 3321 symptomatic, ART-naive, HIV-infected adults with CD4 counts less than 200 cells per μL starting ART were randomly assigned to laboratory and clinical monitoring (LCM; n=1659) or clinically driven monitoring (CDM; n=1662) by a computer-generated list. Haematology, biochemistry, and CD4-cell counts were done every 12 weeks.
The Development of AntiRetroviral Therapy in Africa (DART) trial was designed to investigate whether delivery of ART with or without routine monitoring of CD4-cell counts for efficacy, and haematology and biochemistry for safety, led to similar outcomes in HIV-infected patients receiving ART who had already fulfilled clinical and CD4-count criteria to start ART.
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