drugset / Trial / NCT00017758

The Effect of Efavirenz and Nelfinavir on the Blood Levels of Certain Lipid-Lowering Drugs

NCT00017758

Treatment

Summary

The purpose of this study is to find out whether certain anti-HIV drugs (efavirenz \[EFV\] and nelfinavir \[NFV\]) affect the amount of certain fat-lowering drugs (atorvastatin, pravastatin, and simvastatin) in the blood. Protease inhibitors (PIs), a type of anti-HIV drug, are known to cause increased lipids (fats) in the blood of HIV-infected patients. EFV also is known to increase blood fats. HIV-infected patients who take PIs and/or EFV may need to take fat-lowering drugs to correct this problem. So it is important to look at possible drug interactions when these drugs are taken together. This study will see if taking EFV or NFV, a protease inhibitor, affects the blood level of simvastatin, atorvastatin, or pravastatin (all fat-lowering drugs). To obtain results more quickly, the study population will be healthy HIV-negative volunteers.

Timeline

Start
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Atorvastatin Small molecule
Subject Efavirenz Other / unclassified
Subject Nelfinavir Other / unclassified 1250 mg
Subject Pravastatin Small molecule 40 mg
Subject Simvastatin Small molecule