Stephen’s AIDS Research (SSAR) 2004/0002 study] conducted at Chelsea and Westminster Hospital (London, UK) comparing the same regimens in treatment-naïve patients. The primary aim of that study was to assess the effects on fasting lipids and glucose disposal using euglycaemic hyperinsulinaemic clamps [19]. All 32 patients from that trial were co-enrolled in the BASIC trial and their
follow-up was extended to 48 weeks. Patients were eligible for inclusion if they were HIV-1 infected, ≥18 years Antiinfection Compound Library purchase old, male or non-pregnant female and naïve to antiretroviral therapy, and if they had an indication for initiating cART. Dyslipidaemia at baseline and/or the use of lipid-lowering drugs was not an exclusion criterion for participation in the BASIC trial; however, patients included in the SSAR 2004/0002 study were not allowed to have diabetes mellitus or to receive metabolically Forskolin mouse active medications. The study was approved by the ethics committees of all participating centres, and each patient provided written informed consent. The primary outcome was to demonstrate noninferiority of SQV/r compared with ATV/r with respect to the change in fasting TC after 24 weeks. Secondary outcome measures were differences in changes in metabolic abnormalities, including other lipid parameters
and insulin sensitivity, body composition, renal function, virological and immunological efficacies and overall safety over 48 weeks. Randomization was performed using a computer-generated centralized
schedule. Blood samples were drawn fasting in all patients at baseline and at weeks 4, 12, 24, 36 and 48, except for at week 12 in the SSAR 2004/0002 patients, for whom the original protocol did not include sampling at this time-point. Body composition Lck and markers of glucose metabolism were assessed at baseline and at weeks 24 and 48. A full physical examination was performed at screening, week 24 and week 48, and weight, renal function, immunology, virology and safety at every visit. Fasting lipids, including TC, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides (TG), apolipoprotein A1 (apoA1), apolipoprotein B (apoB), glucose and insulin, were all measured centrally using stored frozen serum samples (Medpace Reference Laboratories, Leuven, Belgium). Cardiovascular risk was assessed using the Framingham risk score at baseline, week 24 and week 48, with the exception of the SSAR 2004/0002 study participants, for whom information about blood pressure was lacking. Total and regional body fat was assessed by dual-energy X-ray absorptiometry (DXA), and visceral (VAT), subcutaneous (SAT) and total abdominal adipose tissue (TAT) by single-slice abdominal computed tomography (CT) scan at the level of the fourth lumbar vertebra.