The Influence of Raltegravir on Pravastatin Pharmacokinetics(GRAPPA)

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.

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