Viral and immunologic dynamics and inflammation sub-study

The objective of this sub-study was to study the relationship between the viral decay and immunologic parameters, to compare the efficacy to reduce specific immune activation and inflammation makers between the two treatment arms, and to study the association between residual viral replication, proviral DNA, immune activation, endothelial activation, and inflammation.

By using highly sensitive markers of immune activation, this sub-study provided a unique opportunity to evaluate if the new drug combinations were better or more sustainable at reducing immune activation than more conventional regimes.

The sample size for this sub-study was 40 patients per arm (80 in total) from selected participating sites.