Lopinavir/ritonavir monotherapy after 24 weeks of second-line antiretroviral therapy in Africa: a randomized controlled trial (SARA).

Background: Boosted protease inhibitor (bPI) monotherapy (bPImono) potentially has substantial cost, safety and operational benefits. It has never been evaluated as second-line antiretroviral therapy (ART) in Africa.

Methods: After 24 weeks of lopinavir/ritonavir-containing second-line therapy, DART participants were randomized to remain on combination therapy (CT), or change to bPImono maintenance (SARA trial; ISRCTN53817258).

Nevirapine clearance from plasma in African adults stopping therapy: a pharmacokinetic substudy.

Objective: To measure nevirapine elimination in African adults undertaking a structured treatment interruption (STI) in the DART trial.

Design: Cohort (16 women, 5 men; median weight 61 kg) within a randomized trial of management strategies.

Methods: Plasma nevirapine was measured by validated high performance liquid chromatography at 0,1,2,3 and 4 weeks after stopping the drug in a subset of patients undertaking an STI.