pharmacokinetic interaction study of steady-state tipranavir/ritonavir (tpv/r) with single-dose valaciclovir (val) in healthy volunteers

Conditions: Healthy

Summary: assessment of the interaction of tipranavir/ritonavir (tpv/rtv) and valaciclovir (val), a prodrug of aciclovir (acv)


Eligibility criteria:
inclusion criteria: * healthy male and non-pregnant, non-lactating female subjects as determined by results of screening * signed written informed consent in accordance with good clinical practice (gcp) and local legislation * the ability to understand and sign a written informed consent form, prior to participation in any screening procedures and willingness to comply with all study requirements * age \>19 and \<59 years (20 - 58 years inclusive) * weight ≥ 60 kg * body mass index (bmi) \>18.5 and \<29.9 kg/m2 exclusion criteria: * any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance * atrioventricular (av) block including 1° * gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hematological, oncological or hormonal disorders * surgery of gastrointestinal tract (except appendectomy) * diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders * relevant history of orthostatic hypotension, fainting spells or blackouts * chronic or relevant acute infections * history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator * known hypersensitivity to tpv, rtv, valaciclovir, aciclovir or antiretroviral drugs (marketed or experimental use as part of clinical research studies) * known elevated liver enzymes in past trials with any compound * intake of drugs with a long half-life (\>24 hours) (\<1 month prior to administration) * prescription or over the counter medications (including vitamins, minerals, herbal supplements and antacids), dietary supplements 14 days prior to study drug administration or expected during the trial) * participation in another trial with an investigational drug (\<2 months prior to administration or expected during trial) * smoker with a consumption of \>10 cigarettes or \>3 cigars or \>3 pipes/day and those who cannot keep tobacco intake constant * alcohol (\>40 g/day for males and \>20 g/day for females) and drug abuse * blood donation or loss \>400 ml, \< 3 month prior to administration * clinically relevant laboratory abnormalities * transaminases above reference values in the history * inability to comply with dietary regimen of study centre for female subjects: * pregnancy or planning to become pregnant within 60 days of study completion * positive pregnancy test * have not been using a barrier method of contraception for at least 3 months prior to participation in the study if of childbearing potential and not surgically sterilized * are not willing or are unable to use a reliable method of barrier contraception (such as diaphragm with spermicidal cream/jelly or condoms with spermicidal foam), during and up to 2 months after completion/termination of the trial if of childbearing potential and not surgically sterilized * chronic use of oral contraception or hormone replacement containing ethinyl estradiol * breast-feeding