NCT01779687

Pharmacokinetic Drug Interaction Study Between Raltegravir and Atorvastatin.

Pharmacokinetic Drug Interaction Study Between Raltegravir and Atorvastatin (AVIATOR).

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• HIV
• Hypercholesterolaemia

Interventions

Type	Name	Description
DRUG	raltegravir	Raltegravir 400 mg BID for 7 days
DRUG	Atorvastatin	Atorvastatin 20 mg QD for 7 days

Timeline

• Start date: 2013-03-01
• Primary completion: 2013-07-01
• Completion: 2013-08-01
• First posted: 2013-01-30
• Last updated: 2020-10-20

Locations

1 site across 1 country: Netherlands