A Dolutegravir Open Label Protocol for HIV Infected, Adult and Adolescent Patients With Integrase Resistance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 75
- 主要终点
- Expanded access
研究概览
简要总结
ING114916 is an open-label, multi-center, expanded access (EAP) study
详细描述
ING114916 is an open-label, multi-center EAP to allow access to patients with HIV-1 infection who have documented raltegravir or elvitegravir resistance, have limited treatment options and require dolutegravir to construct a viable anti-retroviral regimen for therapy. Patients must not be eligible for another ongoing dolutegravir clinical trial in order to participate in this EAP.
The duration of patient accrual into the study will extend until dolutegravir receives local (by country) regulatory approval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects greater than 18 years of age
- •Documented HIV-1 RNA >/= 400 c/mL
- •Documented raltegravir or elvitegravir resistance
- •Inability to construct a viable background ART regimen with commercially available medications.
排除标准
- •Creatnine clearance < 30ml/min via Cockcroft-Gault method
- •Females who are pregnant and/or breastfeeding
- •Patients with known integrase allergic reaction
- •ALT > 5 times the ULN within one month of treatment initiation
- •ALT > 3 times ULN and total bilirubin >1.5 times ULN
- •Evidence of severe hepatic impairment
- •Patients eligible for, and have access to, an actively enrolling DTG Phase III clinical study
- •Any condition or any active clinically significant disease during screening, anticipated requirement for any prohibited concomitant medications -
结局指标
主要结局
Expanded access
时间窗: Not applicable for an expanded access study
To to provide access in an open label protocol program to patients who have documented RAL or ELV resistance, who have limited treatment options and who require DTG to construct a viable ARV regimen for therapy
次要结局
- Assess adverse events(Not applicable for an expanded access study)