The objective of the SIMPATAZ study was to determine the effectiveness and safety of ATV-containing regimens in patients whose physician has recommended simplification of their ARV treatment to improve ease of administration, patient satisfaction, tolerability, or lipid profile, while maintaining Selleckchem RAD001 virological suppression. SIMPATAZ was a multicentre, prospective, noninterventional, post-authorization, investigator-sponsored study that enrolled patients taking stable PI-based treatment whose physician recommended simplification of their ARV drug regimen to a boosted

ATV-containing regimen (ATV 300 mg/ritonavir 100 mg once daily). Recruitment started in July 2005 and finished in October 2006. The study was conducted at 32 sites throughout Spain, and the protocol

was approved by the Spanish Agency for Medicines and Healthcare Products and by the ethics committees at the participating sites. Patients were followed up every 4 months for 1 year. At each visit, patients underwent a routine physical examination and data were collected on HIV RNA level, CD4 cell MG-132 count, liver function, glucose levels, lipid values [total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol and triglycerides], adverse reactions, adherence and satisfaction. Adherence was measured using a validated simplified medication adherence questionnaire (SMAQ) [20], with six qualitative questions on adherence and pills missed during the last week and past 3 months. Satisfaction with ARV treatment was evaluated using an ad hoc questionnaire with six items on a visual scale (1=not satisfied to 5=very

satisfied) for different treatment-related aspects such as ease of administration, tolerability, and disease control as perceived by the patient. Eligible patients were HIV-1-infected adults who had been on their current PI-based regimen (unchanged) for at least 6 months and who had an HIV RNA level below the limit of quantification (LOQ) for at least 4 months before simplification. The decision to switch to an ATV-containing regimen was made before inclusion, and each participant provided signed informed consent. Amino acid Patients were excluded if they were pregnant, had not taken ARV drugs before the study or had previously taken ARV drugs not boosted with ritonavir, or if their life expectancy was<12 months. Other exclusion criteria were noncontrolled diabetes mellitus, current alcohol or drug abuse, acute hepatitis at the beginning of the study or advanced liver disease, specified heart conduction system abnormalities, triglycerides ≥1250 mg/dL, serum creatinine higher than twice the upper limit of normal, aminotransferase levels higher than five times the upper limit of normal, and serum bilirubin levels higher than 3 times the upper limit of normal.