A Retrospective Cohort Study of the Efficacy and Evolution of Comorbidities With the Combination of Raltegravir and Boosted Darunavir in Suppressed HIV-infected Patients With Intolerance or Toxicity to Nucleoside Analogues
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Percentage of patients who maintained virological suppression on treatment at 48 weeks after using this dual therapy
研究概览
简要总结
Retrospective cohort of virologically suppressed HIV-infected patients who received the combination of Raltegravir plus Darunavir boosted with cobicistat or ritonavir, as dual therapy, because or toxicity or intolerance to nucleoside analogues
详细描述
This is a retrospective cohort study including those HIV-infected patients who received the combination of raltegravir plus darunavir boosted with cobicistat or ritonavir as dual therapy, due to the existence of toxicity or intolerance to nucleoside analogues, to evaluate:
- efficacy, measured as percentage of patients free of virological failure after 48 and 96 weeks (ITT-e, snapchot analysis) and improvement in CD4+ count
- tolerance (rate of discontinuation and cause, and frequency of adverse events)
- evolution of different comorbidities (renal, bone, cardiovascular events)
Patients will included if they have received at least 1 dose of the dual therapy
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
- •HIV infection
- •Older than 18 years
- •To have received the combination of raltegravir plus boosted darunavir in patients with virological suppression (more than 6 months) after toxicity or intolerance to nucleoside analogues
排除标准
- •Virological failure in the last 6 months previous to dual therapy
- •Presence or suspicion of resistance to Darunavir (major mutations according to Meyer et al) or to Raltegravir (major mutations according to IAS list)
- •Active hepatitis B
结局指标
主要结局
Percentage of patients who maintained virological suppression on treatment at 48 weeks after using this dual therapy
时间窗: 48 weeks
The number of patients who remained with virological suppression during the study at 48 weeks (ITT-exposed, snapchot analysis)
次要结局
- Change in bone parameters (bone mineral density by Dual X-ray absorptiometry) during the study(48 weeks)
- Change in cardiovascular risk (by using AHA score) for patients using dual therapy(48 weeks)
- Change in renal parameters at 48 weeks,for patients using dual therapy(48 weeks)
- Changes in inflammatory markers during the study, measured by the CD4/CD8 ratio(48 weeks)
研究者
Jose L. Casado
Physician
Asociacion para el Estudio de las Enfermedades Infecciosas