NCT02708342已完成不适用
Observational, Retrospective Analysis to Evaluate Switching to Raltegravir Plus Abacavir/Lamivudine in HIV-1-Infected Patients. ORASWIRAL Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Durability of an antiretroviral regimen of raltegravir plus abacavir and lamivudine
研究概览
简要总结
RESEARCH METHODS Study Design Observational, Retrospective, Single-center, Single-arm Study of patients treated with raltegravir plus abacavir and lamivudine.
详细描述
Adult, male and female HIV-1 infected subjects, who started an antiretroviral regimen of RALTEGRAVIR plus ABACAVIR and LAMIVUDINE after a different antiretroviral regimen.
Subject Selection: Inclusion Criteria
All consecutive patients fulfilling the following inclusion criteria will be considered:
- HIV-1 infected patients,
- age > 18 years,
- Human leukocyte antigen (HLA) B5701-negative
- treatment-experienced patients with viral suppression (HIV-RNA <50 copies/mL), who switched from any antiretroviral drug to raltegravir plus abacavir and lamivudine because of toxicity, convenience or other reasons
- switch from Protease Inhibitor to Raltegravir in patients on Abacavir and lamivudine, switch from any Nucleoside analog reverse-transcriptase inhibitors (NRTI) combination to abacavir and lamivudine in patients on raltegravir, switch to raltegravir plus abacavir and lamivudine from any other combination will all allow the inclusion in the study
- At least one viral load assessed before and at least once after starting the study regimen.
Subject Selection: Exclusion Criteria
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Durability of an antiretroviral regimen of raltegravir plus abacavir and lamivudine
时间窗: time to treatment failure through 96 weeks
次要结局
- Cumulative probability of virological failure(through 96 weeks)
- Proportion of patients with more or equal to grade 2 abnormal laboratory tests(through 96 weeks)
- Proportion of patients with treatment failure(through 96 weeks)
- Proportion of patients with virological failure(through 96 weeks)
- Change in Lymphocytes CD4+(through 96 weeks)
- Change in Lymphocytes CD8+(through 96 weeks)
- Change in Lymphocytes CD4+/CD8+ ratio(through 96 weeks)
- Changes in total cholesterol(through 96 weeks)
- Changes in HDL cholesterol(through 96 weeks)
- Changes in LDL cholesterol(through 96 weeks)
- Changes in triglycerides(through 96 weeks)
- Changes in glucose(through 96 weeks)
- Changes in AST(through 96 weeks)
- Changes in ALT(through 96 weeks)
- Changes in ALP(through 96 weeks)
- Changes in proteinuria(through 96 weeks)
- Changes in creatinine(through 96 weeks)
- Changes in phosphate(through 96 weeks)
- Changes in FIB-4 (liver index)(through 96 weeks)
- Changes in eGFR(through 96 weeks)
- Occurrence of HIV genotypic mutations in plasma samples from patients with virological failure(through 96 weeks)
- Proportion of patients with Adverse events and/or Serious Adverse Events, also according to their severity(through 96 weeks)
研究者
Castagna Antonella
Professor - (PI and Promoter Professor Adriano Lazzarin)
Ospedale San Raffaele
相似试验
已完成
不适用
Study to Describe Treatment Patterns and Outcomes in EGFRm NSCLC Patients in BelgiumCarcinoma, Non-Small-Cell LungNCT03761901AstraZeneca141
Unknown
不适用
The Performance of the Mologic Biomarker Panel in InfectionInfectionSepsisNCT03217552Mologic Ltd600
已完成
不适用
Adalimumab Biosimilar in Clinical PracticePsoriasisNCT04808739Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau604
已完成
不适用
Osilodrostat for the Treatment of Non-Cushing's Disease Cushing's SyndromeCushing's SyndromeNCT05633953RECORDATI GROUP103
已完成
不适用
Retrospective Observational Study Investigating Fluciclovine (18F) (FACBC)Prostatic NeoplasmsNCT02443571Blue Earth Diagnostics714