The Ethics of Switch/Simplify in Antiretroviral Trials: Non-Inferior or Just Inferior?

1. CarrAAminJ 2009 Efficacy and tolerability of initial antiretroviral therapy: a systematic review. AIDS 23 343 353

2. ArribasJRDelgadoRArranzAMuñozRPortillaJ 2009 Lopinavir-ritonavir monotherapy versus lopinavir-ritonavir and 2 nucleosides for maintenance therapy of HIV: 96-week analysis. J Acquir Immune Defic Syndr 51 147 152

3. KatlamaCFenskeSGazzardBLazzarinAClumeckN 2003 TRIZAL study: switching from successful HAART to Trizivir (abacavir-lamivudine-zidovudine combination tablet): 48 weeks efficacy, safety and adherence results. HIV Med 4 79 86

4. GulickRMRibaudoHJShikumaCMLalamaCSchackmanBR 2006 Three- vs four-drug antiretroviral regimens for the initial treatment of HIV-1 infection: a randomized controlled trial. JAMA 296 769 781

5. SorianoVGarcía-GascoPVispoERuiz-SanchoABlancoF 2008 Efficacy and safety of replacing lopinavir with atazanavir in HIV-infected patients with undetectable plasma viraemia: final results of the SLOAT trial. J Antimicrob Chemother 61 200 205

6. MalanDRKrantzEDavidNWirtzVHammondJ 2008 Efficacy and safety of atazanavir, with or without ritonavir, as part of once-daily highly active antiretroviral therapy regimens in antiretroviral-naive patients. J Acquir Immune Defic Syndr 47 161 167

7. World Medical Association 2008 October World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. Available: http://www.wma.net/en/30publications/10policies/b3/17c.pdf. Accessed 5 June 2011

8. CarrAHudsonJChuahJMallalSLawM 2001 HIV protease inhibitor substitution in patients with lipodystrophy: a randomised, multicentre, open-label study. AIDS 15 1811 1822

9. WatersLFisherMWinstonAHiggsCHadleyW 2011 A phase IV, double-blind, multicentre, randomized, placebo-controlled, pilot study to assess the feasibility of switching individuals receiving efavirenz with continuing central nervous system adverse events to etravirine. AIDS 25 65 71

10. EronJJYoungBCooperDAYouleMDeJesusE 2010 Switch to a raltegravir-based regimen versus continuation of a lopinavir-ritonavir-based regimen in stable HIV-infected patients with suppressed viraemia (SWITCHMRK 1 and 2): two multicentre, double-blind, randomised controlled trials. Lancet 375 396 407

11. ArribasJRHorbanAGerstoftJFätkenheuerGNelsonM 2010 The MONET trial: darunavir/ritonavir with or without nucleoside analogues, for patients with HIV RNA below 50 copies/ml. AIDS 24 223 230