drugset / Trial / NCT00630734

Genetic Predictors of Variability in the Drug-drug Interaction Between Darunavir/Ritonavir and Pravastatin

NCT00630734

Non-randomizedParallel-groupOpen-labelTreatment

Summary

Pravastatin (Pravachol) is approved by the Food and Drug Administration (FDA) and is used to treat high cholesterol. Darunavir (Prezista) and ritonavir (Norvir) are approved by the Food and Drug Administration (FDA) to treat HIV infection. When darunavir and ritonavir are given with pravastatin, they can increase the blood levels of pravastatin. The degree of this interaction varies from person to person. The way that darunavir and ritonavir interact with pravastatin may be affected by a person's genetic make-up. Genetic factors (or DNA) are those that people are born with and that make each person unique. Genetic differences are the reason why one person's body traits such as height and hair color are different from another person's body traits. Genetic differences can also affect the way a medication works in the body or the way two medications interact in the body. The purpose of this clinical study is to determine if a person's genetic make-up affects the way darunavir and ritonavir interact with pravastatin in the body.

Timeline

Start
2008-02
Primary completion
2009-10
Completion
2010-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Darunavir Small molecule 600 mg Oral
Subject Pravastatin Small molecule 40 mg Oral
Subject Ritonavir Other / unclassified 100 mg Oral