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.
试验速览
- 阶段
- 2 期
- 入组人数
- 201
- 试验地点
- 7
- 主要终点
- Virologic efficacy of the adherence reinforcement intervention
研究概览
简要总结
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.
详细描述
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:
- The efficacy (and associated factors) at 12 weeks of an intensive 3-months adherence reinfrocement phase;
- 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) ;
- 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 :
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •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
排除标准
- •HIV-2 infection
- •Any Severe clinical event under exploration
- •History of treatment including darunavir or raltegravir.
研究组 & 干预措施
Adherence reinforcement before switch to 3rd-line ART
干预措施: adherence reinforcement (Behavioral)
Adherence reinforcement before switch to 3rd-line ART
干预措施: Antiretroviral Therapy Darunavir/r + Raltegravir + 2 NRTIs (as chosen by the investigators) (Drug)
结局指标
主要结局
Virologic efficacy of the adherence reinforcement intervention
时间窗: 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
Persistent virologic efficacy of the adherence reinforcement intervention
时间窗: 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
Virologic efficacy of 3rd-line ART
时间窗: 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
次要结局
- Resistance to 1st and 2nd-line antiretroviral drugs(Week 12)
- Plasma antiretroviral drugs concentration(Week 64)
- Immunological efficacy of the adherence reinforcement intervention(Week 12)
- Tolerance of 3rd-line ART drugs(Week 64)
- Immunological efficacy of 3rd-line ART(Week 64)
- Adherence to 3rd-line ART(Week 64)
- Resistance to 1st, 2nd and 3rd-line antiretroviral drugs(Week 64)