NCT01381328Unknown不适用
GePheRal: Clinical Validation of the Genotypic Diagnosis of Hiv-1 Resistance to Raltegravir by Parallel Analysis of the Genotype and Phenotype Profiles of Resistance
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- - mean value of fold-change resistance determined by the phenotypic assay at baseline
研究概览
简要总结
The purpose of this study is to correlate the different patterns of resistance mutations observed in vivo in patients failing RAL treatment with the fold-change resistance determined by the phenotypic assay.
详细描述
The secondary objectives are, as follows:
- to establish standardised genotypic assay for the HIV-1 pol gene region (region of interest, sensitivity, mutations involved as primary or compensatory changes, role of polymorphism present at baseline).
- to reach consensus on the algorithm interpretation of in house ex-vivo genotypic evaluations.
- to assess the genetic changes in RAL-failing patients under continuous drug pressure or drug discontinuation (dynamics of the reversion of resistance mutations).
- to evaluate in RAL resistant HIV-1 variants the changes in replication capacity (RC) (baseline vs. following-timepoints).
- to evaluate the immunological and virological trend associated with a raltegravir-regimen failure.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Adult (at least 18 years of age) treatment-experienced, HIV-infected subjects of either sex and of any race, failing to a RAL-containing regimen will be enrolled in the study
排除标准
- 未提供
结局指标
主要结局
- mean value of fold-change resistance determined by the phenotypic assay at baseline
时间窗: baseline
次要结局
- changes of fold-change resistance determined by the phenotypic assay with respect to baseline.(24 and 48 hours, W1, W2, W3 and W4 upon discontinuation)
- genetic changes under continuous drug pressure or drug discontinuation with respect to baseline(dynamics of the reversion of resistance mutations)(24 and 48 hours, W1, W2, W3 and W4 upon discontinuation.)
- changes in CD4, CD4%, CD8, CD8% with respect to baseline(24 and 48 hours, W1, W2, W3 and W4 upon discontinuation)
- changes of the replication capacity with respect to baseline(24 and 48 hours, W1, W2, W3 and W4 upon discontinuation.)
- changes of HIV-RNA with respect to baseline(24 and 48 hours, W1, W2, W3 and W4 upon discontinuation)
研究者
Elisabetta Carini
Professor Massimo Clementi
Università Vita-Salute San Raffaele
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Discovering New Genetic Markers in Adults and Children Who May Be At Risk for Hereditary Forms of CancerCancerNCT03922893Memorial Sloan Kettering Cancer Center1,500
已完成
不适用
Universal- Versus Guidelines-Directed Genetic Testing for Germline Pathogenic Variants Utilizing a Multi-Gene Panel for Inherited Cancers in Non-Western Society.Genetic PredispositionNCT04920513King Hussein Cancer Center3,000
Unknown
4 期
Genotypic Resistance Guided Therapy for Refractory H. Pylori InfectionH Pylori InfectionNCT03555526National Taiwan University Hospital320
已完成
不适用
Evaluation Genotypic, Phenotypic and Prognosis APECED SyndromeAPECEDNCT03751683University Hospital, Lille29
已完成
不适用
Genotypic and Phenotypic Correlates of Resistance to AspirinPlatelet Dysfunction Due to AspirinNCT01361620George Washington University190