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临床试验/EUCTR2019-004999-19-DK
EUCTR2019-004999-19-DK进行中(未招募)1 期

Changes in weight, body composition and metabolic parameters after switch to dolutegravir/lamuvidine compared to continued treatment with dolutegravir/abacavir/lamuvidine for virologically suppressed HIV infection: A randomized open-label superiority trial. The AVERTAS-1 trial - AVERTAS-1

Department of infectious diseases, Hvidovre Hospital0 个研究点目标入组 95 人开始时间: 2020年2月14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
95

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

  • - Individuals = 18 years old with
  • - Diagnosed HIV and
  • - At least 6 months of ongoing treatment with dolutegravir/ abacavir/lamivudine prior to inclusion
  • - No pre-existing viral resistance mutations to lamivudine or to dolutegravir
  • - Plasma viral load (HIV-RNA) < 50 copies/ml
  • 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 80
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 15

排除标准

  • - Pre-existing viral resistance mutations to lamivudine or to dolutegravir
  • - Presence of hepatitis B antigen (HBsAg) or HBV DNA
  • - Cancer within past 5 years
  • - Pregnancy or breastfeeding
  • - Any case of diabetes or cardiovascular disease must be stable as assessed by the treating physician
  • - Women of reproductive potential will be included if using approved contraception

研究者

发起方
Department of infectious diseases, Hvidovre Hospital

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