Raltegravir Non-Inferior to Nucleoside Based Regimens in SECOND-LINE Therapy with Lopinavir/Ritonavir over 96 Weeks: A Randomised Open Label Study for the Treatment Of HIV-1 Infection

Janaki Amin, Mark A Boyd, Nagalingeswaran Kumarasamy, Cecilia L Moore, Marcello H Losso, Chidi A Nwizu, Lerato Mohapi, Stephen J Kerr, Annette H Sohn, Hedy Teppler, Boris Renjifo, Jean-Michel Molina, Sean Emery and David A Cooper

PLOS ONE, 2015, vol. 10, issue 2, 1-13

Abstract: Objective: To determine the durability over 96 weeks of safety and efficacy of lopinavir/ritonavir (LPV/r) and raltegravir (RAL) which was demonstrated to have non-inferior efficacy relative to a regimen of LPV/r with nucleoside/nucleotide reverse transcriptase inhibitors (N(t)RTIs) (Control) in primary analysis at 48 weeks. Design: Open label, centrally randomised trial. Setting: Recruitment was from 37 primary and secondary care sites from Africa, Asia, Australia, Europe and Latin America. Subjects: 541 HIV-1 infected adults virologically failing first-line non-NRTI + 2N(t)RTI, with no previous exposure to protease inhibitors or integrase strand transfer inhibitors were analysed, 425 completed 96 weeks follow up on randomised therapy. Intervention: Randomisation was 1:1 to Control or RAL. Main outcome measures: Differences between the proportion of participants with plasma HIV-1 RNA (VL)

Date: 2015
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Persistent link: https://EconPapers.repec.org/RePEc:plo:pone00:0118228

DOI: 10.1371/journal.pone.0118228

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