EUCTR2016-000087-42-ES进行中（未招募）1 期
A prospective, single arm, open-label 96 week observational trial of the tolerability, adherence and efficacy of a dolutegravir/abacavir/lamivudine single tablet regimen in HIV-1 antibody positive people living with HIV with a history of injection drug use switching from existing ART or starting treatment after discontinuation of ART - TAISTR
niversity College Dublin0 个研究点目标入组 50 人开始时间: 2019年4月11日最近更新:
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
- 50
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
- •HIV1-infected adults (=18 years of age) with a history of IDU as the principal HIV transmission risk factor or with current or recent (past 12 months) history of IDU
- •Either ART naïve or currently receiving an antiretroviral regimen but experiencing problems with adherence or tolerability issues on current ART therapy or restarting ART after an unscheduled treatment interruption
- •Willing to switch current ART regimen
- •No documented viral resistance to currently licensed HIV-1 integrase inhibitors, abacavir and lamivudine (with the exception of M184V) based either on previous HIV-1 genotypic resistance testing or in the judgment of the study investigators
- •Integrase inhibitor naïve (defined as no-prior exposure to any INSTI)
- •Documented negative HLAB*5701 allele
- •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 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Anticipated need for hepatitis C (defined as hepatitis C antibody (Ab) and RNA positive) treatment during the first 24 weeks of the study and subjects with active hepatitis B infection (defined as hepatitis B surface antigen (sAg) positive)
- •Subjects with moderate to severe hepatic impairment (Class B or greater) as determined by Child-Pugh classification;
- •Chronic renal failure defined as eGFR<60mls/min/1.73m2 at screening using the abbreviated Modification of Diet in Renal Disease (MDRD) equation: eGFR (ml/min/1,73 m2) = 175 x (CrS) -1,154 x (age)-0,203 x 0,742 (if female) x 1,21 (if black)
- •Any active illness (including AIDS-defining illness) which in the opinion of the investigator would prevent the subject from completing all study assessments
- •Female subjects who are pregnant, breastfeeding or planning future pregnancies or unwilling to take measures to avoid pregnancy for the study duration
- •Any grade 4 laboratory abnormalities at screening
- •Alanine aminotransferase (ALT) ?5 times the upper limit of normal (ULN), OR ALT ?3xULN and bilirubin ?1.5xULN (with >35% direct bilirubin);
- •Subjects weighing less than 40 kilograms and those are likely to require a Triumeq dose adjustment
- •History or presence of allergy to the study drug or their components
- •A diagnosis of cancer under current active chemotherapy or radiotherapy or having received chemotherapy or radiotherapy for a diagnosis of cancer within the previous 21 days prior to screening
- •Subjects with a documented HLAB*5701 positive test on archived or screening bloods
- •Concurrent use of any contraindicated medication (see section 5.2.2)
研究者
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