tipranavir/ritonavir low dose pharmacokinetics in treatment naive patients

Conditions: HIV Infections

Summary: the purpose of this study is to identify an optimal dose combination(s) of tipranavir (tpv) and ritonavir (rtv) for antiretroviral treatment naïve hiv-1 infected patients that can be used in pivotal trial by assessing the steady-state pharmacokinetics and short-term efficacy and safety


Eligibility criteria:
inclusion criteria: * signed informed consent in accordance with gcp and local regulatory requirements prior to trial participation. * hiv-1 infected men and non-pregnant women who are treatment naïve, with positive serology (eia) confirmed by western blot. * age \> 18 and \< 65 years. * cd4 \> 200 cells/mm3 * viral load (hiv-1 mrna viral load) \> 5,000 copies/ml. * ability to swallow multiple large capsules without difficulty. * acceptable laboratory values that indicate adequate baseline organ function at screening visit. * laboratory values are considered to be acceptable if the severity of any parameter is = \< grade 2, based on the daids/actg grading scale (see appendix 10.2). * acceptable medical history, physical examination, and 12-lead ecg at screening * willingness to abstain from the following starting 2 weeks prior to administration of any study medication and up until the end of the study: o grapefruit or grapefruit juice, seville oranges, st. john's wort, and milk thistle. * willingness to abstain from alcohol 3 days prior to administration of any study medication up to the end of the study. * willingness to abstain from the following starting 3 days prior to pk sampling: o garlic supplements and methylxanthine containing foods or drinks (including coffee, tea, cola, energy drinks, chocolate, etc.). * willingness to abstain from over-the-counter herbal medications for the duration of the study. * willingness to abstain from any over the counter medication 7 days prior to administration of any study medication (including vitamins, minerals, dietary supplements and antacids) during the study until completion of the post study assessments. exclusion criteria: * female patients of reproductive potential who: * have positive serum pregnancy test. * have not been using a barrier method of contraception for at least 3 months prior to participation in the study. * are not willing to use a reliable method of barrier contraception (such as diaphragm with spermicidal cream/jelly or condoms with spermicidal foam), during and 60 days after completion/termination of the trial. * are breast-feeding. * suspected or documented seroconversion within last 6 months * participation in another trial with an investigational medicine within 2 months prior to day 0 of this study. * use of any pharmacological contraceptive (including oral, patch or injectable contraceptives) within 1 month prior to day 0 and for the duration of the study. * use of hormone replacement therapy within 1 month prior to day 0 and anytime during the study. * history of acute illness within 30 days prior to day 0. * have evidence of active or acute hbv or hcv. * alcohol or substance abuse within 1 year prior to screening or during the study. * patients with a history of any illness or allergy that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering tpv. * patients who have taken (within 7 days prior to day 0) any over-the-counter or prescription medication that, in the opinion of the investigator in consultation with the bi clinical monitor, might interfere with absorption, distribution, or metabolism of the study medications. * known hypersensitivity to any ingredients of the test drug. * inability to adhere to the protocol. * genotypic resistance to tipranavir (defined as a tpv mutation score \> 4).