Étude Multicentrique Prospective de la Relation Entre Efficacité Virologique et Observance Chez Des Patients Infectés Par le VIH-1 Traités Par Bictegravir
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 8
- 主要终点
- Proportion of patients with virological failure at 6 months
研究概览
简要总结
Modern once-daily antiretroviral therapies have evolved considerably, improving patients' quality of life. However, sub-optimal adherence to antiretroviral therapy (ART) can lead to insufficient viral suppression and the emergence of resistant HIV strains. In particular, several populations encountered in HIV clinical practice face obstacles to optimal adherence.
The investigators propose the prospective multicenter cohort study BICTECAPS, evaluating the effectiveness of the combination therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in routine practice. The investigators hypothesize that the pharmacokinetic profile and genetic barrier provided by B/F/TAF will enable a high rate of virological suppression at low to moderate levels of adherence, probably 100% virological suppression above 70% adherence.
The study is planned to include 120 patients with HIV infection treated with B/F/TAF, over a planned 2-year period with usual follow-up.
The aim of this work is to evaluate virological suppression rates at 6 and 12 months according to adherence levels defined by electronic antiretroviral monitoring caps (MEMS caps) and by intra-cellular TAF assay on blotting paper (dried blood spot, DBS).
The investigators hope to generate real-life data on B/F/TAF use from population groups generally under-represented in clinical trials, including robust measurements of adherence patterns using MEMS caps and DBS.
. Key words : HIV-1 ; B/F/TAF ; Adherence ; Forgiveness
详细描述
Title Etude multicentrique prospective de la relation entre efficacité virologique et observance chez des patients infectés par le VIH-1 traités par BICTEGRAVIR
Type or research Non interventional research (NIR)
Target population People living with HIV (PLWH)
Objectives Primary objective:
- To explore the effectiveness of antiretroviral treatment with B/F/TAF by virological suppression rate (plasma HIV-RNA) at 6 months in real life according to adherence patterns defined by electronic antiretroviral monitoring caps (MEMS caps) and by intra-cellular TAF assay.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •People living with HIV-1
- •Age greater than or equal to 18 years
- •Having been informed about the study (non-opposition)
- •Acceptance of the use of electronic antiretroviral monitoring caps (MEMS caps)
- •People treated or starting treatment with bictegravir//emtricitabine/tenofovir (B/F/TAF; antiretroviral treatment naïve, changing treatment, virological failure)
排除标准
- •Pregnant women
- •People living with HIV (PLHIV) living in institutionalization, with guardianship or impaired judgment (to avoid bias due to unability to assume responsibility for treatment compliance)
- •PLHIV receiving assistance incompatible with the use of the electronic pillbox.
结局指标
主要结局
Proportion of patients with virological failure at 6 months
时间窗: 6 months
Virological failure is defined as a confirmed plasma viral load \>50 copies/mL (HIV RNA)
次要结局
- Proportion of patients with virological failure at 12 months(12 months)
- Proportion of patients with side-effect(6-12 months)
- Proportion of patients with emerging drug resistance mutations(6-12 months)
- Proportion of patients with good quality of life(6-12 months)
研究者
Laurent HOCQUELOUX, MD
Investigator coordinator
Centre Hospitalier Régional d'Orléans