The Efficacy and Safety of Dolutegravir-based Dual Therapies in 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
- 155
- 试验地点
- 1
- 主要终点
- Efficacy, measured as maintenance of virological suppression, after switching to a dolutegravir-based dual therapy
研究概览
简要总结
The objective of this study was to evaluate the efficacy and safety, and evolution of causes leading to change, of dual therapies based in Dolutegravir in patients requiring a change of virologically effective antiretroviral therapy.
详细描述
Despite the high rate of virological suppression and low risk of toxicity, HIV-infected patients continue to need new antiretroviral strategies, such as dual therapies, because of different end-organ involvement (kidney, bone, cardiovascular..), intolerance or toxicity. To date, only a protease inhibitor (PI)-based regimen was able to permit the use of dual therapies (two antiretrovirals), especially in case of patients with history of virological failure to other regimens. However, the recent license of Dolutegravir, a integrase inhibitor with high genetic barrier, could help to clinicians to manage patients with intolerance or toxicity to nucleoside analogues without putting in risk virological suppression.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Older than 18 years
- •Receiving a virologically effective antiretroviral regimen
- •Switching to a dual therapy based in dolutegravir because of intolerance or toxicity to nucleoside analogues
排除标准
- •Pregnant women
- •Receiving other investigational drugs
- •Recent diagnosis of opportunistic infection (< 1 month)
结局指标
主要结局
Efficacy, measured as maintenance of virological suppression, after switching to a dolutegravir-based dual therapy
时间窗: 12 months
Percent of patients remaining with HIV RNA level below 50 copies/ml, according to a missing=failure criteria
次要结局
- Safety according to DAIDS grade events 2009 of dual therapy based in dolutegravir(12 months)
- Efficacy, measured as maintenance of virological suppression, of different dual therapies with dolutegravir(12 months)
- Outcome of causes leading to switch the previous regimen(12 months)
研究者
Jose L. Casado
Physician, MD, PhD
Asociacion para el Estudio de las Enfermedades Infecciosas