EUCTR2014-002632-14-DE进行中（未招募）1 期
A randomised trial of dolutegravir (DTG)-based antiretroviral therapy vs. standard of care (SOC) in children with HIV infection starting first-line or switching to second-line ART - ODYSSEY (Once daily DTG-based ART in young people vs standard therapy)
PENTA Foundation0 个研究点目标入组 792 人开始时间: 2016年10月7日最近更新:
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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
- 792
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
- •Children =28 days and <18 years weighing =3kg with confirmed HIV-1 infection*
- •Parents/carers and children, where applicable, give informed written consent
- •Girls who have reached menses must have a negative pregnancy test at screening and
- •randomisation and be willing to adhere to effective methods of contraception if sexually
- •Children with co-infections who need to start ART according to local/national guidelines
- •Parents/carers and children, where applicable, willing to adhere to a minimum of 96 weeks'
- •*Children weighing 3 to <14kg must be eligible and willing to participate in the Weight band (WB)-
- •PK1 substudy (these children will not be recruited in Germany) unless enrolment for this weight band directly into the main trial has opened following
- •the WB-PK1 substudy (see Section 5.3.1 and Appendix XIII) or dosing information has become
- •available from the IMPAACT P1093 DTG dose-finding study.
- •Additional criteria for ODYSSEY A:
- •Planning to start first-line ART
- •Additional criteria for ODYSSEY B:
- •Planning to start second-line ART defined as either: (i) switch of at least 2 ART drugs due to
- •treatment failure; or (ii) switch of only the third agent due to treatment failure where drug
- •sensitivity tests show no mutations conferring NRTI resistance (see Section 5.2.2)
- •Treated with only one previous ART regimen. Single drug substitutions for toxicity,
- •simplification, changes in national guidelines or drug availability are allowed
- •At least one NRTI with predicted preserved activity available for a background regimen
- •In settings where resistance tests are routinely available, at least one active NRTI from TDF,
- •ABC or ZDV should have preserved activity based on cumulative results of resistance tests
- •(see Section 5.2.2)
- •In settings where resistance tests are not routinely available, children who are due to switch
- •according to national guidelines should have at least one new NRTI predicted to be available
- •from TDF, ABC or ZDV (see Section 5.2.2)
- •Viral load =500 c/ml at screening visit or within 4 weeks prior to screening
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 700
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •History or presence of known allergy or contraindications to DTG
- •History or presence of known allergy or contraindications to proposed available NRTI
- •backbone or proposed available SOC third agent.
- •Alanine aminotransferase (ALT) =5 times the upper limit of normal (ULN), OR ALT =3xULN
- •and bilirubin =2xULN
- •Patients with severe hepatic impairment or unstable liver disease (as defined by the
- •presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or
- •gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of
- •Gilbert's syndrome or asymptomatic gallstones)
- •Anticipated need for Hepatitis C virus (HCV) therapy during the study
- •Pregnancy or breastfeeding
- •Evidence of lack of susceptibility to integrase inhibitors or more than a 2-week exposure to
- •antiretrovirals of this class
研究者
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