EUCTR2010-018532-40-BE进行中（未招募）不适用
A Phase 2b study to select a once daily oral dose of GSK2248761 in HIV-1 infected antiretroviral therapy experienced adults with non-nucleoside reverse transcriptaseinhibitor (NNRTI) resistance
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 =400copies/mL;
- •3) Previously received or current treatment with antiretroviral therapy (HAART) for
- •HIV-1 infection (patient may be off ART at time of screening);
- •4) HIV-1 harboring NNRTI resistance by screening genotype (defined as the presence
- •of =1 NNRTI resistance-associated mutations
- •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;
- •11.HIV-1 genotype results with any of the following will be excluded:
- •Any screening genotype with virus showing a Y181 mutation in combination with any other NNRTI resistance-associated mutations;
- •Any screening genotype with virus showing a Y181I or Y188L alone or in combination with any other NNRTI resistance-associated mutations;
- •12.HIV-1 phenotype results with any of the following will be excluded:
- •Any screening phenotype with virus showing etravirine fold change >10;
- •Any screening phenotype with virus showing darunavir fold change >20;
- •Any screening phenotype with virus showing raltegravir fold change >1.5;
- •13.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;
- •14.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);
- •15.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 >
研究者
相似试验
进行中（未招募）
不适用
A Phase 2b study to select a once daily oral dose of GSK2248761 in HIV-1 infected antiretroviral therapy experienced adults with non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance. - NDEUCTR2010-018532-40-ITViiV Healthcare UK Ltd150
进行中（未招募）
1 期
A Phase IIb study to select a once daily oral dose of GSK1349572 administered with either abacavir/lamivudine or tenofovir/emtricitabine in HIV-1 infected antiretroviral therapy naïve adult subjects.EUCTR2009-010269-21-FRGlaxoSmithKline Research and Development Ltd200
进行中（未招募）
不适用
A Phase IIb study to select a once daily oral dose of GSK1349572 administered with either abacavir/lamivudine or tenofovir/emtricitabine in HIV-1 infected antiretroviral therapy naïve adult subjects. - NDHIV-1 infected antiretroviral therapy naïve adult subjectsMedDRA version: 12.0Level: LLTClassification code 10064456Term: HIV infection WHO clinical stage IVEUCTR2009-010269-21-ITGlaxoSmithKline Research and Development Ltd200
进行中（未招募）
1 期
A Phase IIb study to select a once daily oral dose of GSK1349572 administered with either abacavir/lamivudine or tenofovir/emtricitabine in HIV-1 infected antiretroviral therapy naïve adult subjects.HIV-1 infected antiretroviral therapy naïve adult subjectsMedDRA version: 9.1Level: LLTClassification code 10008922Term: Chronic infection with HIVEUCTR2009-010269-21-DEViiV Healthcare UK Ltd200
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 subjectsHIV-1 infected antiretroviral therapy naive adult subjectsMedDRA version: 12.1Level: LLTClassification code 10008922Term: Chronic infection with HIVEUCTR2010-018487-16-DEViiV Healthcare UK Ltd150