Analyses were performed using intent-to-treat principles based on

Analyses were performed using intent-to-treat principles based on randomized treatment assignment. Analyses RG7204 mw included all available

data and missing values were ignored. Between-group statistical comparisons used the Wilcoxon rank-sum test for continuous variables and Fisher’s exact test for categorical variables. Within-group changes, from baseline to week 48, were investigated using the Wilcoxon signed rank-sum test. Additional analyses (as-treated) were performed which censored values after a change in any component of the treatment regimen. From March 2007 to April 2008, a total of 225 patients from the MONOI study were randomized. Of these, 156 patients (69%) – 81 patients from the darunavir/r triple-therapy group and 75 from the darunavir/r monotherapy group – were enrolled in the fat distribution substudy and underwent a DEXA scan at baseline. During follow-up, 141 and 129 patients had a DEXA evaluation at week 48 and week 96, respectively. Overall, 121 patients had a complete fat tissue evaluation, including measurements at baseline, week 48 and week 96. Eight patients were evaluated at baseline and week 96. The missing data for fat evaluation are summarized

in Figure 1. Of the initial 156 patients receiving darunavir/r at 600 mg bid, 92% switched to darunavir/r at 800/100 at week 48 in both treatment groups, as specified in the protocol. Over the 96 weeks of follow-up, 24 patients had a treatment modification, including, selleck products in the darunavir/r monotherapy group, a change from darunavir to atazanavir (one patient), raltegravir (one patient) or nevirapine (one patient), and

resumption of NRTIs, including tenofovir or abacavir (10 patients) and zidovudine (two patients); and in the darunavir/r triple-therapy arm, a switch from tenofovir to zidovudine (one patient), from zidovudine to abacavir (one patient) and from zidovudine to tenofovir (six patients), Carnitine palmitoyltransferase II and tenofovir discontinuation (one patient). Baseline patient characteristics were well matched between the two treatment groups (Table 1). Patients enrolled in the fat distribution substudy did not significantly vary from the total patient population. They were middle-aged (median 45 years), with a median duration of exposure to antiretroviral therapy (ART) of 9 years for NRTI regimens, 7.7 years for nonnucleoside reverse transcriptase inhibitors (NNRTIs), and 5.8 years for PIs. Sixty-nine patients (44%) had been exposed to all three classes of drugs. At enrolment, ART therapy for the 156 patients consisted of an NRTI regimen that included tenofovir in 41% of patients, abacavir in 20.5% and thymidine analogues in 32.6%. The NRTI backbone regimen was associated with a PI in 72.4% of patients and with an NNRTI in 27.5%. It should be noted that, during the first 48 weeks of the study, in the darunavir/r triple-therapy arm, 17 patients (21%) received a thymidine analogue, in most cases zidovudine.

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