Leronlimab vs Maraviroc

NCT02859961 · Phase 2/3 · completed

Although participants were randomized to dose groups, the study was open-label with no blinding and had no placebo or active-drug control arm - all arms received leronlimab, just at different doses, so there was no true comparator to establish efficacy against. The primary result was reported as simple percentages per dose group with no significance testing, and over half of enrolled participants discontinued before week 48, so this cannot be read as controlled evidence that leronlimab prevents virologic failure better than an alternative.

NCT00098293 · Phase 3 · completed

This was a large, randomized, quadruple-blind, active-controlled trial comparing maraviroc with efavirenz, but its primary viral-load results were mixed rather than consistently meeting the prespecified non-inferiority margins. The primary endpoint was a virologic surrogate, and the once-daily maraviroc arm was terminated early after an interim analysis found that non-inferiority criteria were not met.