Several studies have evaluated protease inhibitor (PI) monotherapies as a maintenance strategy for patients with suppressed HIV viraemia, and shown that viral suppression selleck compound can be maintained in over 80% of cases without viral resistance emergence
in the event of viral rebound, with a potential benefit in terms of peripheral fat tissue evolution [11-14]. Two recent randomized studies have investigated darunavir/ritonavir (darunavir/r) as a maintenance strategy. The MONET study demonstrated, at week 48, the similarity of darunavir/r monotherapy to standard triple therapy consisting of darunavir/r plus two NRTIs, with darunavir/r monotherapy having an efficacy rate > 85% . Similarly, the MONOI-ANRS 136 study has shown a high efficacy rate, with HIV viral loads maintained below 400 HIV-1 RNA copies/ml in 99% of the per protocol population receiving a darunavir/r triple-drug regimen compared with 94% of those receiving darunavir/r monotherapy . Because the majority c-Met inhibitor of patients included in the MONOI study received treatment with a nonthymidine nucleoside analogue backbone, and because darunavir/r has been associated with
a good tolerability profile [17-22] in both naïve and experienced patients, it was important to evaluate whether darunavir/r monotherapy could be beneficial in terms of fat distribution and metabolic parameters in long-term HIV-infected patients. Therefore, the aim of the MONOI-ANRS 136 body composition substudy was to evaluate the evolution of body fat composition over 96 weeks in the two treatment strategy groups, namely darunavir/r monotherapy and darunavir/r triple therapy with two NRTIs. The MONOI-ANRS 136 study enrolled adult HIV-infected patients who had been on a stable triple-antiretroviral drug regimen for at least 18 months and who had suppressed viraemia, defined as HIV-1 RNA <400 copies/mL for the previous 18 months, and <50 copies/mL at screening. Patients also had a CD4 count nadir >100 cells/μL and no virological failure during treatment with a prior
PI-containing regimen, and no prior HIV-related neurological disease. Oxalosuccinic acid Patients were recruited from 32 clinical sites in France. The protocol was approved by the Ethics Committee of the Pitié-Salpêtrière Hospital and the French Health Product-Safety Agency (AFSSAPS). All patients provided written informed consent. MONOI was a multicentre, randomized, comparative, 96-week open-label trial that had a primary endpoint of efficacy at week 48. After an initial phase of 8 weeks, during which each patient received darunavir/r at 600/100 mg twice daily in combination with two NRTIs, patients were randomly assigned, 1:1, to either continue the triple-drug darunavir-containing regimen (darunavir/r triple therapy) or discontinue the two NRTIs (darunavir/r monotherapy).