Virology Substudy

There is evidence that the novel mechanism of action of HIV integrase inhibitors such as raltegravir may fundamentally alter early viral kinetics following initiation of ART. Raltegravir has been shown to result in a more rapid fall of viral load than has been seen hitherto with the other classes of drugs.

The substudy therefore aims to assess and compare the rapidity of initial virological response between the three treatment arms of EARNEST, and to determine whether the presence of detectable viral load at an early time point predicts subsequent treatment failure. All sites are participating in this substudy, but only a subset of trial participants are included in the analysis.

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