This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. There have recently been reports of patients with human immunodeficiency virus (HIV) developing kidney toxicities while taking the drug Viread . Many of these patients were also taking low-dose (100 mg once or twice daily) ritonavir as part of their HIV treatment regimen. This study is designed to test if the toxicities observed in HIV patients taking Viread might be caused by a drug interaction in the kidney between Viread and ritonavir. The purpose of this study is to test whether there are differences in the amount of Viread the kidneys excrete into the urine in patients who are taking a HIV regimen containing low-dose ritonavir (as Kaletra ) compared to patients who are taking a HIV regimen that does not contain a protease inhibitor. This study will require 2 study visits: one screening visit (approximately 1 hour in length) and one 24-hour overnight visit. Study participants will use their own supply of HIV medications for the study. Blood and urine samples will be collected at both visits to look for the levels of Viread in these fluids. We will compare the levels of Viread in the urine and blood between the 2 groups of patients. We will also draw blood to look at DNA, or inherited genetic material. The DNA will be used to determine the body's inherited ability to absorb, metabolize, transport, eliminate, and respond to HIV medications.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000051-45
Application #
7377825
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2006-04-01
Project End
2007-03-31
Budget Start
2006-04-01
Budget End
2007-03-31
Support Year
45
Fiscal Year
2006
Total Cost
$72,206
Indirect Cost
Name
University of Colorado Denver
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
041096314
City
Aurora
State
CO
Country
United States
Zip Code
80045
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