Pharmacokinetic Drug Interaction Study Between Raltegravir and Atorvastatin.
Status:
Completed
Trial end date:
2013-08-01
Target enrollment:
Participant gender:
Summary
Dyslipidemia is highly prevalent among patients with HIV infection and contributes to the
increased cardiovascular disease risk in this patient population. Atorvastatin lowers plasma
low-density lipoprotein (LDL) cholesterol levels and is used for prevention of
artherosclerotic disease. Raltegravir, an HIV integrase inhibitor, could be one of the
preferred antiretroviral agents in HIV patients with dyslipidemia because it has a beneficial
lipid profile.
Theoretically, no clinically relevant drug interaction is expected between atorvastatin and
raltegravir. However, atorvastatin and raltegravir share similar metabolic pathways which
could be relevant in the occurrence of pharmacokinetic interactions. In order to be able to
recommend raltegravir and atorvastatin concomitant use, a pharmacokinetic study in healthy
volunteers is proposed.