Pharmacokinetic drug interaction study between rAltegraVIr and ATORvastatin (AVIATOR).

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 24

Inclusion Criteria

1. Subject is at least 18 and not older than 55 years at screening.
2. 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
3. Subject has a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2, extremes included.
4. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
5. 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.
6. Subject has a normal blood pressure and pulse rate, according to the Investigator's judgement.

Exclusion Criteria

1. Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
2. Positive HIV test.
3. Positive hepatitis B or C test.
4. 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. hysterec-tomy, 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.
5. Therapy with any drug (for two weeks preceding dosing), except for acetaminophen.
6. Relevant history or presence of pulmonary disorders (especially COPD), cardiovascular disorders, neurological disorders (especially seizures and migraine), psychiatric disorders, gastro-intestinal disor-ders, renal and hepatic disorders, hormonal disorders (especially dia-betes mellitus), coagulation disorders, musculoskeletal and con-nective tissue disorders.
7. Relevant history or current condition that might interfere with drug ab-sorption, distribution, metabolism or excretion.
8. History of or current abuse of drugs, alcohol or solvents.
9. Inability to understand the nature and extent of the study and the pro-cedures required.
10. Participation in a drug study within 60 days prior to the first dose.
11. Donation of blood within 60 days prior to the first dose.
12. Febrile illness within 3 days before the first dose.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Geometric Mean Ratios and 90% confidence intervals of pharmacokinetic<br /><br>parameters (AUC0-t, Cmax, Ct) of raltegravir for raltegravir with atorvastatine<br /><br>vs. raltegravir alone and of atorvastatine for atorvastatine with raltegravir<br /><br>vs. atorvastatine alone.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The safety profile of the combined use of raltegravir and atorvastatin.<br /><br>The comparison of change in LDL cholesterol of short-term atorvastatine use<br /><br>with or without raltegravir. </p><br>