A Cohort Study of Use of Doravirine (DOR) Based Regimens in Clinical Practice in Europe
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 22
- 主要终点
- Proportion of patients with virologic failure (Cohort 1 - treatment naive)
研究概览
简要总结
Following the initiation of Doravirine (DOR) regimen among people living with HIV (PLWH), the study will aim to assess effectiveness, discontinuation, and resistance over the 12-month period.
Retrospective data from 500 patients is planned to be collected from 6 - 10 European sites. Cohort 1 : 400 patients, 100 treatment naïve and 300 virally suppressed patients switching from a 1st or second line treatment, Cohort 2: 50 patients with NNRTI mutations (other than DOR), Cohort 3: 50 patients with NNRTI mutations (including DOR).
The study will be conducted through collaboration with the NEAT ID Network, a well-established network of clinical sites across Europe.
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
- •are HIV positive male or female
- •are aged ≥18 years
- •were prescribed and received at least one dose of DOR (without initial dose adjustment).
- •have started/been switched to DOR for at least 12 months at time of data collection
- •had a resistance genotype available before starting DOR
- •Cohort 1 Specific Inclusion Criteria
- •had no evidence of DOR-associated resistance mutation
- •were on DOR containing ART regimen that also contained 2 fully active nucleos(t)ides and patient had no documented NRTI resistance mutations to the two NRTIs in the combination.
- •Patients who, at the time of initiation, were:
- •Category 1: HIV treatment naïve OR
- •Category 2: Virologically suppressed (HIV-1 RNA <50 copies/mL) for at least 6 months with no evidence of prior virological failure with agents of the NNRTI class
- •Patients in category 1 and 2 above who have NNRTI mutations that do not impact on DOR (K103N, Y181C, and G190A) using the Stanford algorithm (https://hivdb.stanford.edu/hivdb/by-mutations) can be included in this study.
- •Cohort 2 Specific Inclusion Criteria
- •must have evidence of NNRTI associated resistance mutations (other than DOR) according to Stanford algorithm
- •their DOR-containing ART will contain 2 NRTIs but will not include an INSTI and/or a bPI.
- •had no documented resistance to the other drugs in the combination.
- •Patients who, at the time of initiation, were:
- •Category 1: HIV treatment naïve OR
- •Category 2: Virologically suppressed (HIV-1 RNA <50 copies/mL) for at least 6 months
- •Cohort 3 Specific Inclusion Criteria
- •ART naïve or virologically suppressed (HIV-1 RNA <50 copies/mL) for at least 6 months at the time of DOR initiation
排除标准
- •Patients with no documented resistance testing.
- •Patients with no genotype available at DOR initiation
- •Patients enrolled in DOR trials
- •Cohort 1 specific exclusion criteria
- •Patients who have DOR as part of their fourth line or higher therapy
- •Patients with prior virological failure with agents of the NNRTI class
- •Cohort 2 specific exclusion criteria
- •Patients who have an INSTI and/or bPI in their DOR-containing therapy
- •Patients who have NNRTI mutations that impact on DOR
研究组 & 干预措施
Cohort 1
400 patients with no resistance mutations to DOR or NNRTIs.
Cohort 2
Approximately 50 patients with resistance mutations to NNRTIs (other than DOR)
Cohort 3
Approximately 50 patients with or without NNRTI mutations (including DOR)
结局指标
主要结局
Proportion of patients with virologic failure (Cohort 1 - treatment naive)
时间窗: on or after week 48 after DOR initiation
i. Two consecutive HIV RNA VL levels ≥50 copies/mL after reaching at HIV RNA \< 50 copies/mL or ii. One HIV RNA VL level ≥50 copies/mL and DOR regimen is discontinued immediately or at next hospital visit, after reaching HIV RNA \< 50 copies/mL
Proportion of patients with virologic failure (Cohort 2 - treatment suppressed)
时间窗: up to 12 months after initiation of DOR
i. Two consecutive HIV RNA VL levels ≥50 copies/mL after reaching at HIV RNA \< 50 copies/mL or ii. One HIV RNA VL level ≥50 copies/mL and DOR regimen is discontinued immediately or at next hospital visit, after reaching HIV RNA \< 50 copies/mL
Proportion of patients switched for reasons other than virological failure.
时间窗: up to 12 months after initiation of DOR
Proportion of patients switched at any time point for reasons other than virological failure.
Proportion virologically suppressed patients at week 48 who have remained on DOR.
时间窗: Week 48 after DOR initiation
Proportion of patients, virologically suppressed/undetectable (\<50 copies/mL) at week 48 who have remained on DOR.
Proportion of patients with virologic failure (Cohort 1 - treatment naive)
时间窗: on or after week 48 after DOR initiation
i. Two consecutive HIV RNA VL levels ≥50 copies/mL after reaching at HIV RNA \< 50 copies/mL or ii. One HIV RNA VL level ≥50 copies/mL and DOR regimen is discontinued immediately or at next hospital visit, after reaching HIV RNA \< 50 copies/mL
Proportion of patients with virologic failure (Cohort 2 - treatment suppressed)
时间窗: up to 12 months after initiation of DOR
i. Two consecutive HIV RNA VL levels ≥50 copies/mL after reaching at HIV RNA \< 50 copies/mL or ii. One HIV RNA VL level ≥50 copies/mL and DOR regimen is discontinued immediately or at next hospital visit, after reaching HIV RNA \< 50 copies/mL
Proportion of patients switched for reasons other than virological failure.
时间窗: up to 12 months after initiation of DOR
Proportion of patients switched at any time point for reasons other than virological failure.
次要结局
- Proportion of patients with confirmed virologic failure, commonly used to make treatment related clinical decisions (Cohort 1 - treatment naive)(up to 12 months after initiation of DOR)
- Proportion of patients with confirmed virologic failure, commonly used to make treatment related clinical decisions (Cohort 1 - treatment naive)(on or after week 48 after DOR initiation)
- Proportion of patients with confirmed virologic failure, commonly used to make treatment related clinical decisions (Cohort 1 - treatment naive)(up to 12 months after initiation of DOR)
- Estimated proportion of patients with low level viremia(up to 12 months after initiation of DOR)
- HIV resistance subtypes for patients with virologic failure(during the 12-month data collection period.)