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The Influence of Raltegravir on Pravastatin Pharmacokinetics(GRAPPA) (GRAPPA)

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ClinicalTrials.gov Identifier: NCT00665717
Recruitment Status : Completed
First Posted : April 24, 2008
Last Update Posted : June 7, 2011
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Radboud University

Study Description
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Brief Summary:
The purpose of this trial is to determine the effect of raltegravir on pravastatin pharmacokinetics and vice versa by intrasubject comparison.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Pravastatin Drug: Raltegravir Drug: Pravastatin and raltegravir Phase 1

Detailed Description:

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Influence of Raltegravir on Pravastatin Pharmacokinetics in Healthy Volunteers (GRAPPA)
Study Start Date : May 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: A
Pravastatin 40 mg QD for 4 days
 Drug: Pravastatin
40 mg tablet; QD; 4 days
Other Name: Selektine
Active Comparator: B
Raltegravir 400mg BD for 4 days
 Drug: Raltegravir
400mg tablet; BD 4 days
Other Name: Isentress
Experimental: C
Interaction between pravastatin and raltegravir
 Drug: Pravastatin and raltegravir
pravastatin 40mg tablet QD for 4 days; raltegravir 400mg tablet BD for 4 days
Other Name: Selektine and Isentress


Outcome Measures
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Primary Outcome Measures :
  1. Plasma concentrations of pravastatin and raltegravir. [ Time Frame: t=0 (predose), 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and (24: for pravastatin only) hours post ingestion on Days 4, 18 and 32. Trough level on Day 2, 16 and 30. ]

Secondary Outcome Measures :
  1. To investigate the non-steady state changes in serum low density lipoprotein (LDL) cholesterol secondary to pravastatin use in the presence or absence of raltegravir [ Time Frame: Screening and Days 1, 5, 15, 19, 29 and 33. ]
  2. Determination of pharmacokinetic parameters [ Time Frame: at each sampling time ]
  3. To evaluate the safety of combined use of pravastatin and raltegravir [ Time Frame: entire trial ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is at least 18 and not older than 55 years of age.
  • Subject does not smoke more than 10 cigarettes, 2 cigars, or 2 pipes per day.
  • Subject has a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2.
  • Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
  • Subject is in good age-appropriate health condition.
  • Subject has a normal blood pressure and pulse rate.

Exclusion Criteria:

  • Documented history of sensitivity/idiosyncrasy to medicinal products or exci-pients.
  • Positive HIV test.
  • Positive hepatitis B or C test.
  • Pregnant female or breast-feeding female.
  • Therapy with any drug.
  • Relevant history or presence of pulmonary disorders (especially COPD), car-diovascular disorders, neurological disorders (especially seizures and mi-graine), gastro-intestinal disorders, renal and hepatic disorders, hormonal disorders (especially diabetes mellitus), coagulation disorders.
  • Fasting triglyceride levels > 8.0 mmol/L
  • Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
  • History of or current abuse of drugs, alcohol or solvents.
  • Inability to understand the nature and extent of the trial and the procedures required.
  • Participation in a drug trial within 60 days prior to the first dose.
  • Donation of blood within 60 days prior to the first dose.
  • Febrile illness within 3 days before the first dose
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00665717


Locations
Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands
Sponsors and Collaborators
Radboud University
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: David M Burger, PharmD PhD Radboud University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Publication in Journal of Acquired Immune Deficiency Syndromes; Issue: Volume 55(1), 1 September 2010, pp 82-86  This link exits the ClinicalTrials.gov site

Responsible Party: Dr. D.M. Burger, hospital pharmacist, Radboud University Nijmegen Medical Centre
ClinicalTrials.gov Identifier: NCT00665717     History of Changes
Other Study ID Numbers: UMCN-AKF 07.05
First Posted: April 24, 2008    Key Record Dates
Last Update Posted: June 7, 2011
Last Verified: May 2011

Keywords provided by Radboud University:
interaction
statins
pharmacokinetics

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Raltegravir Potassium
Pravastatin
Anti-HIV Agents
 Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors