Pilot Simplification Study to Lopinavir/Ritonavir 800/200 mg Monotherapy Regimen Once Daily
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- plasma viral load <40 copies/mL
研究概览
简要总结
Lopinavir/ritonavir monotherapy is currently a well known and widely used strategy, while Lopinavir/ritonavir 800/200 mg once a day in a triple-therapy was approved a few years ago. The purpose of this study is to evaluate efficacy and safety of Lopinavir/ritonavir 800/200 mg monotherapy once a day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients older than 18, HIV positive
- •Patients receiving a monotherapy regimen (Lopinavir/ritonavir twice daily)during the last 6 months
- •Undetectable viral load (<40 copies/ml) during the last 6 months
- •Patients that accept participation in the study and sign the Informed Consent Form
- •Childbearing females with negative pregnancy tests and using appropriate contraceptive measures
排除标准
- •Opportunistic disease, cancer or any other active disease with specific treatment
- •Active addiction to illegal drugs or active use of psychotropic drugs
- •Mental retardation diagnosis, or mental dementia or severe psychiatric disorder (excluding major depression disorder solved > 3 months)
- •Females who are breastfeeding or pregnant
研究组 & 干预措施
Lopinavir/ritonavir 800 mg / 200mg
Kaletra 200/50 mg comprimidos recubiertos con película Lopinavir/ritonavir 800 mg / 200mg will be changed from its approved posology (2 times daily)to once daily in patients with undetectable viral load and in stable treatment with Lopinavir/ritonavir 800 mg / 200mg in monotherapy for at least 6 months
干预措施: Lopinavir/ritonavir 800 mg / 200mg (Drug)
结局指标
主要结局
plasma viral load <40 copies/mL
时间窗: Week 48
HIV Plasma Viral Load \<40 copies/ml at week 48.
次要结局
- Stability in the plasma levels of Lopinavir/ritonavir during all study visits(Weeks 4, 8, 12, 16, 24, 36 and 48)
- Tolerability(Weeks 4, 8, 12, 16, 24, 36 and 48)
- Adherence(Weeks 4, 8, 12, 16, 24, 36 and 48)
- Satisfaction(Weeks 4, 8, 12, 16, 24, 36 and 48)
- - Efficacy in CSF(At least 4 weeks on study treatment)
研究者
Daniel Podzamczer
MD. HIV/AIDS Program Director. HIV Unit. Infectious Disease Service
Hospital Universitari de Bellvitge