Optimization of HIV-1 DNA Genotyping by High Throughput Sequencing to Document Antiretroviral Resistant Mutations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- > Genotyping Score (GSS) comparison between HIV DNA-UDS genotyping assay obtained at inclusion and cumulative RNA-Sanger genotyping assays obtained at each virological failure during routine follow
研究概览
简要总结
The analysis of HIV resistance to antiretrovirals (Sanger sequencing on RNA) is difficult when the viral load is undetectable or during therapeutic breaks. In these situations, the ultra-deep sequencing (UDS) can be done on proviral DNA in order to improve characterization of archived resistant variants with may reflect past virological failures.
This study is a cross-sectional study which will require only one additional tube which can be taken during a routine check-up as part of the usual follow-up of the individuals included.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Patient who has given consent
- •Adult patient
- •Patient living with HIV-1
- •Controlled viral load (<50 RNA copies/ml) for at least 1 year.
- •At least two previous virologic failures, either :
- •Initial failure : defined as the persistence of a viral load greater than 50 copies/ml beyond 1 year, after the initiation of triple antiretroviral therapy, and without virological control (VL > 50 copies/ml) since the initiation of the very first antiretroviral treatment.
- •A rebound in HIV viral load to more than 50 copies/ml after a period of virological success, confirmed on two consecutive samples at least one month apart.
- •At least 2 Sanger RNA genotypes have been done or could be done from the existing library.
排除标准
- •Patient not affiliated to a medical insurance scheme
- •Protected adult
- •Pregnant, parturient or breastfeeding woman
- •Discontinuation of clinical and immuno-virological follow-up for more than 2 years
结局指标
主要结局
> Genotyping Score (GSS) comparison between HIV DNA-UDS genotyping assay obtained at inclusion and cumulative RNA-Sanger genotyping assays obtained at each virological failure during routine follow
时间窗: baseline
次要结局
未报告次要终点