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

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
|
- 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. ]
- 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. ]
- Determination of pharmacokinetic parameters [ Time Frame: at each sampling time ]
- To evaluate the safety of combined use of pravastatin and raltegravir [ Time Frame: entire trial ]

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

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
Netherlands | |
Radboud University Nijmegen Medical Centre | |
Nijmegen, Gelderland, Netherlands |
Principal Investigator: | David M Burger, PharmD PhD | Radboud University |
Additional Information:
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 |