drugset / Trial / NCT01779687

Pharmacokinetic Drug Interaction Study Between Raltegravir and Atorvastatin.

NCT01779687

RandomizedCrossoverOpen-labelOther

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.

Timeline

Start
2013-03
Primary completion
2013-07
Completion
2013-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Atorvastatin Small molecule 20 mg
Subject Raltegravir Other / unclassified 400 mg