EUCTR2006-005256-33-IT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 - ND
BOEHRINGER ING.0 个研究点目标入组 84 人开始时间: 2007年10月15日最近更新:
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相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 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
- •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/mm**3 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 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: -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: -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.
- •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
- •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).
研究者
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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 patientsThe patients for this study are to be HIV-1 infected antiretroviral treatment-naïve men and women, from 18 to 65 years of age.MedDRA version: 9.1Level: LLTClassification code 10020192Term: HIV-1EUCTR2006-005256-33-DEBoehringer Ingelheim Pharma GmbH & Co. KG84
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