EUCTR2014-002632-14-PT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)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 700
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 <18 years weighing ¿14kg with confirmed HIV-1 infection and DTG dose known for child's weight-band*
- •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 active
- •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' follow-up
- •*Children weighing 14 to <20kg must be eligible and willing to participate in the Weight band (WB)-PK1 substudy unless enrolment for this weight band directly into the main trial has opened following the WB-PK1 substudy 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
- •Treated with only one previous ART regimen. Single drug substitutions for toxicity, or 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 tenofovir, abacavir or zidovudine should have preserved activity based on cumulative results of resistance tests
- •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 available from tenofovir, abacavir or zidovudine
- •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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