跳至主要内容
临床试验/NCT06928090
NCT06928090Enrolling By Invitation不适用

A Retrospective Observational Study of Efficacy and Safety of DTG/3TC(Dolutegravir/Lamivudine) in Treatment-naïve HIV-1 Infected Patients From at Real-life Cohort in Korea

Chungnam National University Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年1月24日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
200
试验地点
1
主要终点
Percentage of patients achieving viral suppression

研究概览

简要总结

Non-interventional, retrospective, single arm study of individuals who have initiated a DTG/3TC regimen. Medical chart will be reviewed by the investigators. Naive subjects will be identified by the clinic database as having initiated DTG/3TC.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • HIV-1 diagnosis
  • Prescribed DTG/3TC alone to manage HIV-1 infection as initial antiretroviral treatment at the study centers

排除标准

  • HIV-2 diagnosis
  • Previous antiretroviral treatment

研究组 & 干预措施

DTG/3TC

Single arm cohort

干预措施: DTG + 3TC FDC (Drug)

结局指标

主要结局

Percentage of patients achieving viral suppression

时间窗: At week 48 after DTG/3TC treatment

Virological suppression is HIV RNA viral load \< 50 copies/mL

次要结局

  • Change in CD4+cell counts(From baseline to week 48)
  • Persistence on DTG/3TC(At 48 weeks)
  • Reasons for Discontinuation(Up to 48 weeks.)
  • Changes in BMI(From baseline to week 48)
  • Changes of lipid profile(From baseline to week 48)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yeon-sook, Kim

Professor

Chungnam National University Hospital

研究点 (1)

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