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HIV and AIDS
48 weeks of treatment. Treatment response is defined as a viral load of compared for signs and symptoms of lypodystrophy as well as lipid
less than 50 HIV-RNA copies/ml measured in plasma at two consecutive and glycaemic abnormalities.
visits prior to week 48 and without subsequent rebound or change of
antiretroviral therapy prior to week 48. The main inclusion and Current Status
exclusion criteria are summarised in Table 1. The ArTEN trial was initiated in 2006 and has recruited patients in
Germany, Spain, Switzerland, Portugal, Romania, Poland, the UK, Italy,
Prior to randomisation, all patients underwent drug-resistance Argentina and Mexico. Patient enrolment was completed in February
testing, mainly to exclude subjects with mutations that could 2008 and results on the primary end-point are expected to be available
compromise response to NNRTIs (see Figure 1). Patients had been during the first quarter of 2009. Since the initiation of the study, an
randomised to receive 200mg of NVP twice a day (BID), 400mg of independent virology data and safety monitoring board (DSMB) has
NVP daily (QD) or 300mg of ATZ boosted with 100mg of ritonavir, conducted three reviews of the clinical data to ensure patient safety. The
with a backbone regimen of TDF/FTC (Truvada). Patients in the NVP most recent review, in July 2008, included data from 561 patients at up
arms started their treatment with 200mg QD and increased to either to 56 weeks after initiation of therapy. Based on the data provided, the
200mg BID or 400mg QD after two weeks. Patients are being DSMB did not identify any safety concerns that would warrant
observed for a period of 48 weeks, with a planned extension period modification of the ArTEN study as currently designed. The first
of up to 144 weeks. Patients also had the opportunity to voluntarily presentation of the ArTEN results is scheduled for July 2009 at the IAS
participate in a metabolic substudy in which NVP and ATZ/r are meeting in Cape Town, South Africa. ■
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44 EUROPEAN INFECTIOUS DISEASE
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