EUCTR2010-018487-16-DE进行中（未招募）不适用
Phase 2b study to select a once daily oral dose of GSK2248761 administered with tenofovir/emtricitabine or abacavir/lamivudine in HIV-1 infected antiretroviral therapy naive adult subjects
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
- 150
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
- •1) HIV-1 infected adults =18 years of age. A female is eligible to enter and participate in the study if she falls into one of the following categories:
- •a. Non-childbearing potential; or, b. Child-bearing potential, with a negative pregnancy test at screen and Day 1 and agrees to one of the methods of contraception listed below. Premenarchal females who develop child-bearing potential while on study will also be expected to follow one of the methods of contraception listed below:
- •-Complete abstinence from intercourse from 2 weeks prior to administration of
- •IP, throughout the study, and for at least 2 weeks after discontinuation of all
- •study medications. Should a subject of child-bearing potential decide to
- •become sexually active during the course of the study, she must be counseled
- •and be willing to use one of the other contraception methods listed below:
- •-Double barrier method (male condom/spermicide, male condom/diaphragm,
- •diaphragm/spermicide).
- •-Any intrauterine device (IUD) with published data showing that the expected
- •failure rate is <1% per year (not all IUDs meet this criterion).
- •-Any other method with published data showing that the lowest expected
- •failure rate for that method is <1% per year.
- •Note: Since no data is currently available on interactions between hormonal
- •contraceptives and GSK2248761, hormonal contraceptives are excluded medications in this study unless supportive drug interaction data becomes available.
- •Note:Non-child-bearing potential is defined as pre-menopausal with a documented tubal ligation, hysterectomy or bilateral oophorectomy; or post-menopausal defined as 24 months of spontaneous amenorrhea.
- •Any contraception method must be used consistently and in accordance with the
- •approved product label.
- •All study subjects should be counseled on the practice of safer sexual practices including
- •the use of effective barrier methods (e.g. male condom/spermicide).
- •2) HIV-1 infection with a screening plasma HIV-1 RNA =1000copies/mL;
- •3) CD4+ cell count =200 cells/mm3;
- •4 )Antiretroviral-naive;
- •Note: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1)Any pre-existing physical or mental condition (including substance abuse disorder) which, may interfere with the subject’s ability to comply with the study requirements or which may compromise the safety of the subject
- •2)Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the drug or render the subject unable to take oral medication
- •3)Women who are currently breastfeeding
- •4)Any evidence of an active Centers for Disease and Prevention Control (CDC) Category C disease, except cutaneous Kaposi’s sarcoma not requiring systemic therapy
- •5)History of ongoing or clinically relevant hepatitis within the previous 6 months, including chronic hepatitis B virus (HBV) infection (HBsAg positive). Asymptomatic individuals with chronic hepatitis C virus (HCV) infection will not be excluded
- •6)History of liver cirrhosis with or without hepatitis viral co-infection;
- •7)Ongoing or clinically relevant pancreatitis
- •8)History of the following cardiac diseases: myocardial infarction, congestive heart failure, documented hypertrophic cardiomyopathy, sustained ventricular tachycardia;
- •9)Personal or known family history of prolonged QT syndrome
- •10)History or presence of allergy or intolerance to the study drugs or their components, or a history of drug or other allergy that, in the opinion of the Principal Investigator, contraindicates their participation. In addition, if heparin is used during PK sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled
- •Exclusionary genotypes:
- •11)Evidence of viral resistance to any antiviral drug indicative of primary transmitted resistance in a screening or historical resistance test result
- •Exclusionary lab values at screening:
- •12)Any acute laboratory abnormality at screening, which, in the opinion of the Investigator, would preclude the subject’s participation in the study of an investigational compound. Any verified Grade 4 laboratory abnormality at screening would exclude a subject from study participation unless the Investigator can provide a compelling explanation for the laboratory result(s) and has the assent of the medical monitor
- •13)Any of the following laboratory values at screening:
- •Creatinine clearance <50 mL/min via Cockroft-Gault method;
- •Alanine aminotransferase (ALT) =5 times ULN. Subjects with ALT > 2xULN but <5xULN may participate in the study, if in the opinion of the Investigator and GSK medical monitor the lab abnormality will not interfere with the study procedures or compromise subject safety;
- •Alanine aminotransferase (ALT) =3xULN and bilirubin =1.5xULN (with >35% direct bilirubin);
- •14)Any clinically significant finding on screening electrocardiograph (ECG), specifically (a single repeat is allowed to determine eligibility):
- •Heart rate <45 and >100bpm (males), <50 and >100bpm (females); Note: A heart rate from 100 to 110 BPM can be rechecked within 30 minutes to verify eligibility.
- •QRS duration >120msec;
- •QTc interval > 450msec;
- •Non-sustained (= 3 consecutive beats) or sustained ventricular tachycardia;
- •Sinus pauses >2.5 seconds;
- •2nd degree (Type II) or higher AV (Atrioventricular) block;
- •Evidence of WPW (Wolff-Parkinson-White) syndrome (ventricular preexcitation);
- •Pathologic Q waves (defined as Q wave > 40msec OR depth >0.4 mV);
- •Any other abnormality which in the opinion of the investigator would interfere with the safety of the subject
- •Exclusionary tr
研究者
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