Accumulating evidence suggests that generalised chronic immune activation is the major mechanism underlying HIV pathogenesis. While viral load is a strong predictor of the rate of CD4 T cell decline and clinical progression, T cell activation marker expression is also increased during HIV-1 infection. This increase diminishes in tandem with declining viraemia following initiation of ART.
The aim of the immunophenotyping substudy is to determine the differences in frequency of T cell activation marker expression in patients randomised to the different treatment arms of EARNEST. Relevant data will be obtained by immunophenotyping additional T-cell subsets in 300 EARNEST participants. Only the JCRC site in Kampala, Uganda, and at UZCRC in Harare, Zimbabwe, will be enrolling patients into this substudy.