EUCTR2012-002663-10-GB进行中（未招募）1 期
A phase IV, open-label single-arm study investigating the pharmacokinetics and pharmacodynamics of the antiretroviral combination of rilpivirine and ritonavir-boosted darunavir in therapy-naive HIV-1 infected patients. - Darunavir/ritonavir and rilpivirine in therapy-naïve patients
St Stephen's AIDS Trust0 个研究点目标入组 36 人开始时间: 2012年10月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
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
入选标准
- •- Patient has signed and dated informed consent document, confirming their knowledge of the pertinent aspects of the study and willingness to comply with all study requirements, prior to screening procedures.
- •- Male or female aged 18 to 65 years.
- •- HIV-1 infected with less than and including 14 days total exposure to antiretroviral therapy – prior antiretrovirals as post-exposure prophylaxis permissible if documented negative test at 3 months following exposure. If patient has previously taken up to and including 14 days antiretroviral therapy during HIV-1 infection, this must not be within 12 weeks of the screening visit and there must be an available genotypic resistance test after last intake which indicates full viral susceptibility to study medication.
- •- CD4 count >50 cells/mm3 at screening.
- •- HIV-1 RNA > 1000 copies/mL at screening.
- •- Women of childbearing potential (WoCBP); negative urine ß-hCG pregnancy test at screen and baseline visit.
- •- WOCBP, male patients and their partners must use two forms of contraception, one of which is an effective barrier method, when participating in sexual activity which could result in conception throughout the study and for 28 days following the last dose of study medication.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •- Infected with HIV-2
- •- Any medical, psychiatric or substance misuse disorders felt by the investigator to impact on the subject’s ability to participate in the study, including a positive urine test for drugs of abuse (cannabinoids are not exclusionary).
- •- Disallowed concomitant medication as per the summary of product characteristics for darunavir or rilpivirine
- •- Any genotypic resistance mutations on screening or prior tests to darunavir (V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V and L89V) or rilpivirine (K101E, K101P, E138A, E138G, E138K, E138R, E138Q, V179L, Y181C, Y181I, Y181V, H221Y, F227C, M230I, and M230L).
- •- Screening ALT or AST elevation greater than 5 times the upper limit of normal.
- •- Any active opportunistic infection within 4 weeks prior to planned baseline visit.
- •- Any active cardiovascular, pulmonary, hepatic, renal or metabolic disease, or therapy used to treat these diseases, which in the opinion of the investigator could affect the absorption, distribution, metabolism or efficacy of the study medication.
- •- Any known or suspected allergic reaction to the investigational products or excipients (including E110 allergy with regard to darunavir tablets).
- •- Hepatitis B or C co-infection (defined as positive hepatitis B surface antigen or positive hepatitis C antibody; patients with positive hepatitis C antibody with undetectable RNA will be eligible for inclusion).
- •- Estimated GFR (MDRD method) less than 50 ml/min
- •- Use of proton pump inhibitors, or H-2 antagonists more than once daily
- •- Subject has one or more of the following risk factors for QTc prolongation:
- •i. a confirmed prolongation of QT/QTc interval, e.g., repeated demonstration of QTcF (Fridericia correction) interval > 450 ms in the screening ECG.
- •ii. pathological Q-waves (defined as Q-wave > 40 ms or depth > 0.4-0.5 mV).
- •iii. evidence of ventricular pre-excitation.
- •iv. electrocardiographic evidence of complete or incomplete left bundle branch block or complete or clinically significant incomplete right bundle branch block.
- •v. evidence of second or third degree heart block.
- •vi. intraventricular conduction delay with QRS duration > 120 ms.
- •vii. bradycardia as defined by sinus rate < 50 bpm.
- •viii. personal or family history of long QT syndrome.
- •ix. personal history of cardiac disease (including congenital heart disease), symptomatic or asymptomatic arrhythmias, with the exception of sinus arrhythmia.
- •x. syncopal episodes.
- •xi. risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, hypomagnesemia).
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