Dyslipidemia is highly prevalent among patients with HIV infection and contributes to the
increased cardiovascular disease risk in this patient population. Atorvastatin lowers plasma
low-density lipoprotein (LDL) cholesterol levels and is used for prevention of
artherosclerotic disease. Raltegravir, an HIV integrase inhibitor, could be one of the
preferred antiretroviral agents in HIV patients with dyslipidemia because it has a
beneficial lipid profile.
Theoretically, no clinically relevant drug interaction is expected between atorvastatin and
raltegravir. However, atorvastatin and raltegravir share similar metabolic pathways which
could be relevant in the occurrence of pharmacokinetic interactions. In order to be able to
recommend raltegravir and atorvastatin concomitant use, a pharmacokinetic study in healthy
volunteers is proposed.
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Inclusion Criteria:
- Subject is at least 18 and not older than 55 years at screening.
- Subject does not smoke more than 10 cigarettes, 2 cigars, or 2 pipes per day for at
least 3 months prior to the first dosing
- Subject has a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2, extremes included.
- Subject is able and willing to sign the Informed Consent Form prior to screening
evaluations.
- Subject is in good age-appropriate health condition as established by medical
history, physical examination, electrocardiography, results of biochemistry,
haematology and urinalysis testing within 4 weeks prior to the first dose. Results of
biochemistry, haematology and urinalysis testing should be within the laboratory's
reference ranges. If laboratory results are not within the reference ranges, the
subject is included on condition that the Investigator judges that the deviations are
not clinically relevant. This should be clearly recorded.
- Subject has a normal blood pressure and pulse rate, according to the Investigator's
judgement.
Exclusion Criteria:
- Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
- Positive HIV test.
- Positive hepatitis B or C test.
- Pregnant female (as confirmed by an hCG test performed less than 4 weeks before day
1) or breast-feeding female. Female subjects of childbearing potential without
adequate contraception, e. g. hysterectomy, bilateral tubal ligation, (non-hormonal)
intrauterine device, total abstinence, double barrier methods, or two years
post-menopausal. They must agree to take precautions in order to prevent a pregnancy
throughout the entire conduct of the study.
- Therapy with any drug (for two weeks preceding dosing), except for acetaminophen.
- Relevant history or presence of pulmonary disorders (especially COPD), cardiovascular
disorders, neurological disorders (especially seizures and migraine), psychiatric
disorders, gastro-intestinal disorders, renal and hepatic disorders, hormonal
disorders (especially diabetes mellitus), coagulation disorders, musculoskeletal and
connective tissue disorders.
- 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 study and the procedures
required.
- Participation in a drug study 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.