NCT06289361进行中（未招募）不适用
Immunovirological Follow-up and Safety of HIV-infected Patients Receiving Lenacapavir Under Compassionate Access in France Between 01/01/2021 and 12/31/2023
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba23 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2024年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 58
- 试验地点
- 23
- 主要终点
- proportion of participants with plasma HIV RNA < 50 copies/ml 26 weeks after first LEN injection
研究概览
简要总结
Immunovirological follow-up and safety of HIV-infected patients receiving lenacapavir under compassionate access in France between 01/01/2021 and 12/31/2023
详细描述
Retrospective descriptive cohort of patients who received Lenacapavir under compassionate access in France with 50 patients in 25 sites in France
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who received compassionate access to LEN between 01/01/2021 and 20/12/202
排除标准
- •Absence of visits with virological assessment subsequent to inclusion visit
- •Participant opposition to use of follow-up data
结局指标
主要结局
proportion of participants with plasma HIV RNA < 50 copies/ml 26 weeks after first LEN injection
时间窗: Week 26
次要结局
- Proportion of patients with capsid resistance mutations emergence at time of virological failure response) compared with initiation (D0)(between Week 26 and Week 52)
- incidence of side effects and laboratory abnormalities on LEN treatment(between week 26 and Week 52)
- evolution of HIV-1 or HIV-2 RNA over time(between week 26 and Week 52)
- evolution of CD4, CD8 lymphocyte counts and CD4/CD8 ratio over time(between week 26 and Week 52)
- Determination by multivariate analysis of factors associated with virological success 26 weeks after the first LEN injection factors associated with virological control 26 weeks after the first LEN injection(Week 26)
研究者
研究点 (23)
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