A multicentre, 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: 2016年2月11日最近更新: 2022年2月7日

研究概览

暂无简介。

•HIV-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 adherence or tolerability issues on current ART 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

•Anticipated need for hepatitis C treatment during the first 24 weeks of the study
•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 estimated by eGFR <60mls/min/1.73m2 at screening using the abbreviated Modification of Diet in Renal Disease (MDRD) equation
•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
•Subjects with moderate to severe hepatic impairment (Class B or greater) as determined by Child-Pugh classification;
•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

发起方

niversity College Dublin