A pilot randomized trial comparing an intensive versus a standard intervention in stable HIV-infected patients with moderate-high cardiovascular risk

OBJECTIVES: The influence on the progression of atherosclerosis of an intervention on cardiovascular risk factors in HIV-infected patients remains unknown. We evaluated the efficacy and safety of an intensive versus a standard intervention in HIV-infected patients with moderate-high cardiovascular risk. METHODS: A pilot randomized clinical trial. Stable HIV-infected patients with viral suppression on antiretroviral therapy, and two or more cardiovascular risk factors or a Framingham risk score >or=10%. An intensive intervention targeting low-density lipoprotein (LDL)-cholesterol <100 mg/dl, using antiplatelet therapy, and switching protease inhibitor (PI) therapy, was compared with the standard intervention aiming for LDL-cholesterol <130 mg/dL. The primary endpoint was progression of atherosclerosis measured by the carotid intima-media thickness (cIMT). Secondary endpoints were efficacy in achieving the LDL-cholesterol goal, changes in inflammatory biomarkers, and feasibility and safety of the intervention. RESULTS: Thirty-two (47%) and 36 (53%) patients were assigned to the intensive and the standard interventions, respectively. After 12 months, the median proportion of change in the cIMT was +1.63% (-4.95 to +10.54) in the intensive intervention, and +1.79% (-6.61 to +6.1) in the standard group (P = 0.59). LDL-cholesterol (39% versus 7%, P < 0.001) and Framingham score (10% versus 0%, P = 0.03) showed larger reductions in the intensive group. No significant changes in levels of C-reactive protein, interleukin-6 and tumour necrosis factor-alpha were found. No significant adverse events were reported and no virological failures occurred during the study. CONCLUSIONS: An aggressive intervention targeting LDL-cholesterol in HIV-infected patients was safe and capable of attaining very stringent target levels in adherent patients. However, the intervention did not influence cIMT progression or inflammatory biomarkers after 1 year of follow-up.