A Simplified Therapy Regimen Study of Lopinavir and Ritonavir Combined With Lamivudine for HIV-1 Infected Patients in the Real World of China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- The rate of virus inhibition
研究概览
简要总结
To observe the efficacy and safety of simplified therapy regimen for treating with HIV-1 infected patients in Chinese real word.
详细描述
This is an phase IV open-label, multicenter, single-arm clinical trial in. A total of 600 cases were planned to be recruited. These cases were given simplified therapy regimen of lopinavir (200mg) and ritonavir (50mg) (500mg, oral, bid ) combined with lamivudine (300mg, oral, qd. The observation duration is thirty-sixth months. Patients will be followed up before and 12, 24 and 36 months after receiving the simplified regimen, observing the viral inhibition rate and the change of CD4 cell count, the safety and patients'compliance.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •HIV-1 infection confirmed
- •Agree to use simplified therapy regimen.
- •Agree to detect CD4 count at least once per half a year
排除标准
- •Have participated in HIV vaccine clinical trial or other drug trials in the past three months.
- •Patients who could not complete the scheduled follow-up (such as weakness and poor compliance).
- •Patients who have the history of resistance or allergy to LPV/r or 3TC.
研究组 & 干预措施
Lpv/r+3TC
These cases were given simplified therapy regimen including lopinavir(200mg) and ritonavir(50mg)500 mg,oral,bid) combined with lamivudine (300 mg,oral,qd).
干预措施: Lpv/r+3TC (Drug)
结局指标
主要结局
The rate of virus inhibition
时间窗: 36 Months
the ratio of HIV RNA\< 50 copies/mL at 12, 24 or 36 months after treatment.
次要结局
- The immunological ability(36 Months)
研究者
Linghua LI
Vice Chief physician
Guangzhou 8th People's Hospital