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Sponsors and Collaborators: |
University of Colorado at Denver and Health Sciences Center Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA |
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Information provided by: | University of Colorado at Denver and Health Sciences Center |
ClinicalTrials.gov Identifier: | NCT00630734 |
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.
Condition | Intervention | Phase |
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HIV Infections Hyperlipidemia |
Drug: Pravastatin, darunavir, ritonavir |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study |
Official Title: | Genetic Predictors of Pharmacokinetic Variability in the Drug-Drug Interaction Between Darunavir/Ritonavir and Pravastatin: the Role of SLCO1B1 Polymorphisms. |
Estimated Enrollment: | 36 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental |
Drug: Pravastatin, darunavir, ritonavir
Days 1-4: Pravastatin 40 mg QD; Days 5-11: Washout; Days 12-14: Darunavir 600mg/Ritonavir 100mg BID Days 15-18: Darunavir 600mg/Ritonavir 100 mg BID + Pravastatin 40 mg QD
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Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Christina L Aquilante, PharmD | 303-315-3119 | christina.aquilante@uchsc.edu |
United States, Colorado | |
University of Colorado Denver and Health Sciences Center | Recruiting |
Denver, Colorado, United States, 80262 | |
Contact: Christina L Aquilante, PharmD 303-315-3119 christina.aquilante@uchsc.edu | |
Sub-Investigator: Peter L Anderson, PharmD | |
Sub-Investigator: Jennifer J Kiser, PharmD | |
Sub-Investigator: Lisa A Kosmiski, MD | |
Sub-Investigator: Uwe Christians, PhD |
Principal Investigator: | Christina L Aquilante, PharmD | University of Colorado Denver and Health Sciences Center |
Responsible Party: | University of Colorado Denver and Health Sciences Center ( Christina Aquilante, Pharm.D. ) |
Study ID Numbers: | COMIRB07-0272, TMC114HIV4003 |
Study First Received: | February 28, 2008 |
Last Updated: | March 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00630734 |
Health Authority: | United States: Food and Drug Administration; United States: Colorado Multiple Institutional Review Board; United States: University of Colorado General Clinical Research Center |
HIV Pravastatin Darunavir Ritonavir Genetic |
Sexually Transmitted Diseases, Viral Hyperlipidemias Metabolic Diseases Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Darunavir Virus Diseases Pravastatin |
Ritonavir HIV Infections Sexually Transmitted Diseases Metabolic disorder Retroviridae Infections Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Anti-Infective Agents HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Antilipemic Agents Enzyme Inhibitors |
Anticholesteremic Agents Infection Hydroxymethylglutaryl-CoA Reductase Inhibitors Antiviral Agents Pharmacologic Actions Protease Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections |