Normal healthy subjects will participate in this study. The study will look at whether giving FDA-approved anti-HIV drugs (HIV inhibitors) and FDA-approved lipid-lowering drugs together affects drug levels in the blood. Subjects will be randomly assigned to receive one of four treatment combinations. Both subjects and the investigators will know what drug combination they are receiving. Subjects will come to the Clinical Research Center on days 4 and 18. On these days, they will take the morning study drug doses in the clinic after having eaten a special breakfast meal set as part of the study. A small tube (IV) will be put into the vein in the arm and left in place during their stay. Ten blood samples will be taken over the 24 hour period from the IV. Each sample will require 1 teaspoon of blood. Subject have the option to stay for about 24 hours in the Clinical Research Center, or may stay for 12 hours and then return the next morning to have 1 teaspoon of blood drawn. On days 4 and 18, subjects will also have a medical history taken, a physical examination done and about 1 tablespoon of blood drawn before receiving study drugs. On the day 18 visit, if subjects are capable of becoming pregnant, they will have a blood or urine pregnancy test done to make sure they are not pregnant. Arm 4: Subjects will come to the Clinical Research Center on days 14 and 18. On these days, they will take the morning doses of drugs in the clinic and will stay in the clinic for about 8 hours. The study drugs will be given after having eaten a special breakfast meal set as part of the study. A small tube (IV) will be put into a vein in the arm and left in place during their stay. Eight blood samples will be taken from the IV over the 8 hours. Each sample will require 1 teaspoon of blood. Also while subjects are in the clinic for these visits, they will have a medical history taken, a physical examination done and about 1 tablespoon of blood drawn prior to receiving the drugs. Finally, if they are capable of becoming pregnant, a blood or urine pregnancy test will be done to make sure hey are not pregnant.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000400-33
Application #
6440687
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2000-12-01
Project End
2001-11-30
Budget Start
Budget End
Support Year
33
Fiscal Year
2001
Total Cost
Indirect Cost
Name
University of Minnesota Twin Cities
Department
Type
DUNS #
168559177
City
Minneapolis
State
MN
Country
United States
Zip Code
55455
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