Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Radboud University Merck |
---|---|
Information provided by: | Radboud University |
ClinicalTrials.gov Identifier: | NCT00665717 |
The purpose of this trial is to determine the effect of raltegravir on pravastatin pharmacokinetics and vice versa by intrasubject comparison.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Pravastatin Drug: Raltegravir Drug: Pravastatin and raltegravir |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study |
Official Title: | The Influence of Raltegravir on Pravastatin Pharmacokinetics in Healthy Volunteers (GRAPPA) |
Estimated Enrollment: | 24 |
Study Start Date: | May 2008 |
Study Completion Date: | October 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Active Comparator
Pravastatin 40 mg QD for 4 days
|
Drug: Pravastatin
40 mg tablet; QD; 4 days
|
B: Active Comparator
Raltegravir 400mg BD for 4 days
|
Drug: Raltegravir
400mg tablet; BD 4 days
|
C: Experimental
Interaction between pravastatin and raltegravir
|
Drug: Pravastatin and raltegravir
pravastatin 40mg tablet QD for 4 days; raltegravir 400mg tablet BD for 4 days
|
Pravastatin is a first choice statin for HIV-infected patients. Therefore, raltegravir and pravastatin are expected to be co-administered frequently in HIV-infected patients.Since both agents share the same metabolic pathway, there is a potential for a pharmacokinetic drug-drug interaction.
Because co-administration will be indicated in many HIV-infected patients, it is essential to investigate this potential interaction.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Netherlands, Gelderland | |
Radboud University Nijmegen Medical Centre | |
Nijmegen, Gelderland, Netherlands |
Principal Investigator: | David M Burger, PharmD PhD | Radboud University |
Responsible Party: | Radboud University Nijmegen Medical Centre ( Dr. D.M. Burger, hospital pharmacist ) |
Study ID Numbers: | UMCN-AKF 07.05 |
Study First Received: | April 23, 2008 |
Last Updated: | October 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00665717 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
interaction statins pharmacokinetics |
Virus Diseases Pravastatin Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Healthy Retroviridae Infections Immunologic Deficiency Syndromes |
Antimetabolites RNA Virus Infections Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Antilipemic Agents Enzyme Inhibitors |
Anticholesteremic Agents Infection Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Therapeutic Uses Lentivirus Infections |