In contrast, most prospective studies of HAART-treated patients have not found accelerated bone loss during treatment [3–5] except for studies monitoring BMD immediately after HAART initiation, which found BMD loss up to 1 year after treatment initiation
[6,7]. However, a BMD substudy from the Strategies for Management of Antiretroviral Therapies (SMART) study [8] showed a larger BMD loss in patients on continuous HAART compared with patients in the CD4-guided treatment interruption arm [9], indicating that HAART is a risk factor for accelerated bone loss. Thus the results of prospective studies have not been conclusive and there are only a few randomized studies that have measured BMD at specific bone sites [10] with sufficient follow-up ABT-263 research buy [7,9]
to evaluate the long-term consequences of ongoing HAART on BMD. The primary aim of the present study was to compare changes in BMD over 144 weeks in HIV-infected patients initiating either nucleoside reverse transcriptase inhibitor (NRTI)-sparing or protease inhibitor-sparing HAART. The secondary aim was to identify factors associated with changes in BMD. In the open-labelled multicentre investigator-initiated SPAR trial (Comparison of Nucleoside Reverse Transcriptase Inhibitor-Sparing and BIBW2992 order Protease Inhibitor-Sparing Highly Active Antiretroviral Therapy in Antiretroviral-Naïve HIV Infected Patients), 104 HAART-naïve patients were randomized 1:1 to an NRTI-sparing regimen consisting of lopinavir/ritonavir 533/133 mg twice daily and efavirenz 600 mg once daily or a protease inhibitor (PI)-sparing regimen consisting of zidovudine/lamivudine 150/300 mg twice daily and efavirenz 600 mg once daily with 144 weeks of follow-up. Randomization was stratified by centre. A new lopinavir tablet formulation was
Hydroxychloroquine purchase licensed in Denmark in 2006 and a protocol amendment of February 2006 allowed lopinavir/ritonavir 533/133 mg capsules to be substituted with lopinavir/ritonavir tablets 400/100 mg. In contrast to lopinavir/ritonavir capsules, the tablet formulation of lopinavir/ritonavir does not require dose adjustments for concomitant use with efavirenz in antiretroviral-naïve patients [11]. We measured plasma concentrations of lopinavir for the new dose of 400/100 mg tablets twice daily to ensure that the plasma lopinavir concentrations were within the therapeutic range. The primary endpoint of the SPAR study was changes in peripheral fat mass assessed by regional dual energy X-ray absorptiometry (DEXA) scans. Three of five centres participated in the BMD substudy, and enrolled patients had site-specific DEXA scans performed to evaluate spine and hip BMD at baseline and at weeks 24, 48, 96 and 144.