JAC Advance Access originally published online on July 22, 2009
Journal of Antimicrobial Chemotherapy 2009 64(3):589-598; doi:10.1093/jac/dkp250
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Original research |
A pilot randomized trial comparing an intensive versus a standard intervention in stable HIV-infected patients with moderate–high cardiovascular risk
1 Infectious Diseases Unit, Hospital General Universitario de Elche, Department of Clinical Medicine, University Miguel Hernández, Elche, Alicante, Spain 2 Biochemistry Section, Hospital General Universitario de Elche, Elche, Alicante, Spain 3 Infectious Diseases Service, Hospital Clínic-IDIBAPS, University of Barcelona, Barcelona, Spain
Received 11 May 2009; returned 24 May 2009; revised 21 June 2009; accepted 22 June 2009
* Corresponding author. Unidad de Enfermedades Infecciosas, Hospital General Universitario de Elche, Department of Clinical Medicine, University Miguel Hernández, Camí de la Almazara 11, 03203 Elche, Spain. Tel: +34-96-667-91-54; Fax: +34-96-667-91-56; E-mail: marmasia{at}ya.com
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 
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-
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.
Keywords: atherosclerosis , HIV infection , statins , lipid-lowering therapy