Comparison of Virological and Immunological Results of Efavirenz-based Regimen in HIV-infected Patients With or Without Allergic Reactions to Nevirapine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 559
- 试验地点
- 1
- 主要终点
- Time to Virological failure
研究概览
简要总结
The primary objective of this study is to compare the effectiveness of EFV-based regimens in HIV-1-infected patients who; (1) were previously allergic to NVP and stopped all ARV simultaneously; (2) were previously allergic to NVP and continued the other NRTIs for a period of time, i.e. "staggered interruption"; and (3) started EFV-based regimens as an initial regimen (as controlled group).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-70 years old
- •documented HIV infection
- •started EFV-based regimens between January 2002 and December 2008 at Bamrasnaradura Infectious Diseases Institute
排除标准
- •previously received non-HAART regimens such as dual NRTIs regimen, AZT monotherapy with single-dose NVP in pregnancy patients
- •previously received protease inhibitor-based regimen
- •diseases or conditions that significantly affected either kidney or liver functions such as decompensated liver cirrhosis, ESRD
研究组 & 干预措施
Simultaneous interruption (Exposure gr)
stopped all drugs in NNRTI-based regimens simultaneously after allergic reactions to NVP-based regimens, and later started EFV-based regimens
干预措施: Efavirenz-based regimens (Drug)
Naive (Control group)
HIV-1-infected patients who started EFV-based regimens as their initial ARV regimens.
干预措施: Efavirenz-based regimens (Drug)
staggered interruption (exposure group)
after having allergic reactions to NVP-based regimens, stopped NNRTIs first, continued the other NRTIs for a period of time, i.e. "staggered interruption", and later started EFV-based regimens
干预措施: Efavirenz-based regimens (Drug)
结局指标
主要结局
Time to Virological failure
时间窗: until end of study cohort
Virological failure was defined as either (1) two consecutive results of plasma HIV-1 RNA \>400 copies/ml or (2) plasma HIV-1 RNA \>1,000 copies/ml with genotypic resistance assay revealed NRTI or NNRTI resistance-associated mutations
次要结局
- Virological suppression(24 months)
- Median increase from baseline of CD4 cell count(24 months)
- Adverse events(until end of cohort)
- Clinical outcomes such as death, major opportunistic infections, immune recovery syndrome, non-AIDS events(until end of cohort)