Back to resultsThe Influence of Raltegravir on Pravastatin Pharmacokinetics(GRAPPA) (GRAPPA)
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
Pravastatin
Raltegravir
Pravastatin and raltegravir
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring interaction, statins, pharmacokinetics
Eligibility 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
Sites / Locations
- Radboud University Nijmegen Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
A
B
C
Arm Description
Pravastatin 40 mg QD for 4 days
Raltegravir 400mg BD for 4 days
Interaction between pravastatin and raltegravir
Outcomes
Primary Outcome Measures
Plasma concentrations of pravastatin and raltegravir.
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
Determination of pharmacokinetic parameters
To evaluate the safety of combined use of pravastatin and raltegravir
Full Information
NCT ID
NCT00665717
First Posted
April 23, 2008
Last Updated
October 16, 2020
Sponsor
Radboud University Medical Center
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00665717
Brief Title
The Influence of Raltegravir on Pravastatin Pharmacokinetics(GRAPPA)
Acronym
GRAPPA
Official Title
The Influence of Raltegravir on Pravastatin Pharmacokinetics in Healthy Volunteers (GRAPPA)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Radboud University Medical Center
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this trial is to determine the effect of raltegravir on pravastatin pharmacokinetics and vice versa by intrasubject comparison.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
interaction, statins, pharmacokinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
Pravastatin 40 mg QD for 4 days
Arm Title
B
Arm Type
Active Comparator
Arm Description
Raltegravir 400mg BD for 4 days
Arm Title
C
Arm Type
Experimental
Arm Description
Interaction between pravastatin and raltegravir
Intervention Type
Drug
Intervention Name(s)
Pravastatin
Other Intervention Name(s)
Selektine
Intervention Description
40 mg tablet; QD; 4 days
Intervention Type
Drug
Intervention Name(s)
Raltegravir
Other Intervention Name(s)
Isentress
Intervention Description
400mg tablet; BD 4 days
Intervention Type
Drug
Intervention Name(s)
Pravastatin and raltegravir
Other Intervention Name(s)
Selektine and Isentress
Intervention Description
pravastatin 40mg tablet QD for 4 days; raltegravir 400mg tablet BD for 4 days
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
Title
Determination of pharmacokinetic parameters
Time Frame
at each sampling time
Title
To evaluate the safety of combined use of pravastatin and raltegravir
Time Frame
entire trial
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M Burger, PharmD PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud University Nijmegen Medical Centre
City
Nijmegen
State/Province
Gelderland
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
20395869
Citation
van Luin M, Colbers A, van Ewijk-Beneken Kolmer EW, Verweij-van Wissen CP, Schouwenberg B, Hoitsma A, da Silva HG, Burger DM. Drug-drug interactions between raltegravir and pravastatin in healthy volunteers. J Acquir Immune Defic Syndr. 2010 Sep;55(1):82-6. doi: 10.1097/QAI.0b013e3181d9a354.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/20395869
Description
Publication in Journal of Acquired Immune Deficiency Syndromes; Issue: Volume 55(1), 1 September 2010, pp 82-86
Learn more about this trial
The Influence of Raltegravir on Pravastatin Pharmacokinetics(GRAPPA)
We'll reach out to this number within 24 hrs