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Third Line Antiretroviral Treatment Optimization in Sub-Saharan Africa (THILAO)

2017年2月16日 更新者：ANRS, Emerging Infectious Diseases

Systematic "Adherence Intervention" Phase Before Switching to 3rd-line ART in Patients With 2nd-line ART Virologic Failure in Sub-Saharan Africa : a Phase 2b Non-randomized Study.

Thilao is a multi-country, phase 2b, non-randomized study, in Burkina Faso, Cote d'Ivoire, Mali and Senegal, West Africa.

HIV-1 adults with 2nd-line ART virologic failure (plasma HIV-1 RNA >1000 copies/ml) will be recruited and followed in two phases:

  • First, a 12-week intentive adherence reinforcement phase, during which patients will continue 2nd-line ART, be seen repeatidly for counseling and educational training on adherence, and be offered the possibility of phone, SMS and home visit contacts with social workers;

  • Second, a 48-week phase, during which:

    • Patients successfully resuppressed at the end of the first phase will continue 2nd-line ART and adherence reinforcement;
    • Patients with persitent virologic failure will switch to a darunavir/r + raltegravir-based 3rd-line ART.

Genotype resistance tests will be performed retrospectively on frozen samples. The main outcome will be the percentage of patients with plasma HIV-1 viral RNA <50 copies/ml at 64 weeks.

研究概览

地位

未知

条件

干预/治疗

详细说明

Main objective

To estimate, in sub-Saharan African HIV-1 infected adults who failed a NNRTI-base first-line ART and then a PI-based second-line ART:

  1. The efficacy (and associated factors) at 12 weeks of an intensive 3-months adherence reinfrocement phase;
  2. In patients who successfully resuppress at 12 weeks: The percentage of patients still with continuing succesfull virologic supression on 2nd-line ART at 64 weeks (and factors associated to success) ;
  3. In patients with persistent failure at 12 weeks : The efficacy (and associated factors) at 64 weeks of a darunavir/r + raltegravir-based 3rd-line regimen.

Number of participants : 200

Main outcome :

  • At 12 weeks : Proportion of patients with a plasma HIV-1 RNA <400 copies/ml and/or with a decrease in plasma HIV-1 RNA >2 log10 copies/ml between inclusion and 12 weeks;
  • At 64 weeks : proportion of patients with a plasma HIV-1 RNA <50 copies/ml.

Inclusion criteria:

  • Age >18 years
  • Documented HIV-1 infection.
  • History of failing a NNRTI-based 1st-line ART
  • Current PI-based 2nd-line ART >6 months
  • Plasma HIV-1 RNA >1000 copies/ml
  • Signed informed consent

研究类型

介入性

注册 (实际的)

201

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 塞内加尔
      • Dakar、塞内加尔
        • CHU Fann
  • 布基纳法索
      • Bobo-Dioulasso、布基纳法索
        • CHU Souro Sanou
      • Ouagadougou、布基纳法索
        • CHU Yalgado Ouedraogo
  • 科特迪瓦
      • Abidjan、科特迪瓦
        • Centre de Prise en Charge et de Formation (CePReF), Association ACONDA
      • Abidjan、科特迪瓦
        • Service des Maladies Infectieuses et Tropicales (SMIT)
  • 马里
      • Bamako、马里
        • Centre d'Ecoute, de Soins, d'Animation et de Conseils (CESAC)
      • Bamako、马里
        • CHU point G

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Age >18 years
  • Documented HIV-1 infection
  • History of failing a NNRTI-based 1st-line ART
  • Current PI-based 2nd-line ART >6 months
  • Plasma HIV-1 RNA >1000 copies/ml
  • Signed informed consent

Exclusion Criteria:

  • HIV-2 infection
  • Any Severe clinical event under exploration
  • History of treatment including darunavir or raltegravir.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Adherence reinforcement before switch to 3rd-line ART
行为的：adherence reinforcement
Directly observed treatment at home (family or relatives DOT); pillboxes; phone calls; SMS; home visits; adherence reinforcement sessions by trained health workers.
药品：Antiretroviral Therapy Darunavir/r + Raltegravir + 2 NRTIs (as chosen by the investigators)

Second-line ART regimen : ongoing regimen at the time of inclusion will be continued.

Third-line ART regimen : Darunavir/r + Raltegravir + 2 NRTIs (as chosen by the investigators)

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Virologic efficacy of the adherence reinforcement intervention
大体时间：Week 12
Proportion of patients with plasma viral load <400 copies/ml at Week 12 and/or with a decrease in plasma viral load >2 log10 copies/ml between inclusion and Week 12
Week 12
Persistent virologic efficacy of the adherence reinforcement intervention
大体时间：Week 64
Proportion of patients with plasma viral load <50 copies/ ml at Week 64 among those who stayed on 2nd-line ART at Week 16
Week 64
Virologic efficacy of 3rd-line ART
大体时间：Week 64
Proportion of patients with HIV-1 plasma viral load <50 copies/ml at Week 64 among those with persistent failure at Week 12 who switched to 3rd-line ART
Week 64

次要结果测量

结果测量
措施说明
大体时间
Immunological efficacy of the adherence reinforcement intervention
大体时间：Week 12
CD4 count evolution between inclusion and Week 12
Week 12
Immunological efficacy of 3rd-line ART
大体时间：Week 64
CD4 count evolution between Week12 and Week 64 among patients who switched to 3rd-line ART at Week 16
Week 64
Tolerance of 3rd-line ART drugs
大体时间：Week 64
Incidence of grade 3-4 adverse events (ANRS grading table) in patients on 3rd-line ART
Week 64
Adherence to 3rd-line ART
大体时间：Week 64
3rd-line Medication Possession Ratio between Week 16 and Week 64
Week 64
Resistance to 1st and 2nd-line antiretroviral drugs
大体时间：Week 12
Resistance mutations to antiretroviral drugs among patients with virological failure at Week 12
Week 12
Resistance to 1st, 2nd and 3rd-line antiretroviral drugs
大体时间：Week 64
Resistance mutations to antiretroviral drugs among patients with virological failure at Week 64
Week 64
Plasma antiretroviral drugs concentration
大体时间：Week 12
Plasma antiretroviral drugs concentration at Week 12
Week 12
Plasma antiretroviral drugs concentration
大体时间：Week 64
Plasma antiretroviral drugs concentration at Week 64
Week 64

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

ANRS, Emerging Infectious Diseases

调查人员

  • 首席研究员：Serge P. Eholié, MD, MSc, Pr、Service des Maladies Infectieuses et Tropicales, CHU de Treichville, Abidjan, Côte d'Ivoire
  • 首席研究员：Roland Landman, MD、Institut de Médecine et d'Epidémiologie Appliquée - Hôpital Bichat Claude Bernard, Paris, France
  • 学习椅：Pierre-Marie Girard, MD, PhD、Infectious Diseases Department, University Hospital Saint Antoine, Paris, France
  • 研究主任：Xavier Anglaret, MD, PhD、Inserm 897, University of Bordeaux, France

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年3月1日

初级完成 (实际的)

2016年8月1日

研究完成 (预期的)

2017年5月1日

研究注册日期

首次提交

2013年12月30日

首先提交符合 QC 标准的

2013年12月31日

首次发布 (估计)

2014年1月1日

研究记录更新

最后更新发布 (实际的)

2017年2月17日

上次提交的符合 QC 标准的更新

2017年2月16日

最后验证

2017年2月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • ANRS 12269 THILAO

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