The Influence of Raltegravir on Pravastatin Pharmacokinetics(GRAPPA)
This study has been completed.
Sponsor:
Radboud University
Collaborator:
Merck
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00665717
First received: April 23, 2008
Last updated: June 6, 2011
Last verified: May 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Influence of Raltegravir on Pravastatin Pharmacokinetics in Healthy Volunteers (GRAPPA) |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by Radboud University:
Primary Outcome Measures:
- 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. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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. ] [ Designated as safety issue: Yes ]
- Determination of pharmacokinetic parameters [ Time Frame: at each sampling time ] [ Designated as safety issue: No ]
- To evaluate the safety of combined use of pravastatin and raltegravir [ Time Frame: entire trial ] [ Designated as safety issue: Yes ]
| 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 |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00665717
Locations
| Netherlands | |
| Radboud University Nijmegen Medical Centre | |
| Nijmegen, Gelderland, Netherlands | |
Sponsors and Collaborators
Radboud University
Merck
Investigators
| Principal Investigator: | David M Burger, PharmD PhD | Radboud University |
More Information
Additional Information:
No publications provided
| 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 |
| Study First Received: | April 23, 2008 |
| Last Updated: | June 6, 2011 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Radboud University:
|
interaction statins pharmacokinetics |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Pravastatin Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013