EUCTR2006-005256-33-DE进行中（未招募）不适用
A multicenter, randomized, open label, clinical trial to evaluate three doses of tipranavir boosted with ritonavir (500 mg/200 mg qd, 250 mg/100 mg bid and 500 mg/100 mg bid) by assessing the steady-state pharmacokinetics and short-term efficacy and safety in HIV-1 positive treatment naïve patients
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •3.3.1Inclusion criteria
- •Patients meeting the following criteria will be eligible for participation in this study:
- •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:
- •oGrapefruit 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:
- •oGarlic 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria
- •Patients with any of the following criteria are excluded from participation in this trial:
- •Female patients of reproductive potential who:
- •oHave positive serum pregnancy test.
- •oHave not been using a barrier method of contraception for at least 3 months prior to participation in the study.
- •oAre 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.
- •oAre 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).
研究者
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