This SARA protocol separately explored issues of the best specific regimens for second-line combination ART following first-line 2NRTI/NNRTI or triple NRTI regimens, specifically, which ARV combinations could best provide an optimised background regimen to support Aluvia.
It was a three centre open-label randomised trial in HIV infected adults receiving Aluvia containing second-line ART in Africa to evaluate the efficacy of maintenance monotherapy with ritonavir-boosted lopinavir (Aluvia tablets) following initiation with 24 weeks of combination therapy in second-line ART in Africa.
The main objective was to compare two strategies for second-line ART after 24 weeks of combination Aluvia (or Kaletra) containing ART: Arm 1: continued combination Aluvia-containing ART; Arm 2: maintenance with Aluvia monotherapy. Patients were randomized in a 1:1 ratio and followed up to 96 weeks. The initial data were encouraging and this was the basis for a larger clinical end-point trial called EARNEST (described below).
