NCT03311945已完成3 期
Phase 3b, Single Arm, Single Site Simplification Study of HIV-1 Infected Patients With Virological Suppression Under the Combination of Lamivudine (150 mg BID) Plus Raltegravir (400 mg BID) Switching to Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) : Roll-over Study of the RALAM Clinical Trial (NCT02284035)
Judit Pich1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2018年5月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Proportion of Patients With Therapeutic Failure
研究概览
简要总结
Phase 3b, single arm, single site simplification study of HIV-1 infected patients with virological suppression under the combination of Lamivudine (150 mg BID) plus Raltegravir (400 mg BID) switching to Lamivudine (300 mg QD) plus Raltegravir (1200 mg QD): Roll-over study of the RALAM clinical trial (NCT02284035)
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 in the switch arm who have completed the 24-week follow-up of RALAM (NCT02284035) study and remain virologically suppressed (viral load <50 copies/mL) on dual therapy with lamivudine plus Raltegravir
- •Patients who have signed informed consent to participate in the study.
排除标准
- •Pregnancy, lactation, or planned pregnancy during the study period
- •Any disease or history of disease which, in opinion of the investigator, might confound the results of the study or pose additional risk to patient treatment
- •Hepatitis B co-infection
研究组 & 干预措施
Raltegravir + Lamivudine
Experimental
Lamivudine (300 mg QD) plusRaltegravir (1200 mg QD)
干预措施: Raltegravir (Drug)
Raltegravir + Lamivudine
Experimental
Lamivudine (300 mg QD) plusRaltegravir (1200 mg QD)
干预措施: Lamivudine (Drug)
结局指标
主要结局
Proportion of Patients With Therapeutic Failure
时间窗: 48 weeks
Proportion of patients that at least present one of the following events: virological failure, change in antirretroviral treatment for any reason, consent withdrawal, loss to follow-up or death.
次要结局
- Change From Baseline in Peripheral Mononuclear Blood Cells HIV-1 Reservoir(48 weeks)
- Changes From Baseline in Cholesterol Total(24 weeks)
- Changes From Baseline in Cholesterol LDL(24 weeks)
- Changes From Baseline in Cholesterol HDL(24 weeks)
- Changes From Baseline in Triglycerides(24 weeks)
- Changes From Baseline in Insulin Resistance (HOMA-IR)(24 weeks)
- Change From Baseline in Lumbar and Femoral Bone Mineral Density(48 weeks)
- Change From Baseline in Plasma 25-OH Vitamin D Levels(48 weeks)
- Change From Baseline in Urine Beta-2-microglobulin(48 weeks)
- Change From Baseline in Estimated Glomerular Filtration Rate (Chronic Kidney Disease Epidemiology CollaborationI)(48 weeks)
- Change From Baseline in Urine Protein/Creatinine Ratio(48 weeks)
- Changes From Baseline in Biomarkers of Inflammation IL-6(48 weeks)
- Changes From Baseline in Biomarker of Mononuclear Activation SD-163(48 weeks)
- Changes From Baseline in Biomarker of Mononuclear Activation SD-14(48 weeks)
- Changes From Baseline in Biomarker of Inflammation High Sensitivity C-reactive Protein(48 weeks)
- Changes From Baseline in Sleep Quality (Pittsburgh Sleep Quality Index) at(48 weeks)
- Change From Baseline in EQ-5D-5L(48 weeks)
- Incidence of Adverse Events(48 weeks)
- Viral Load(48 weeks)
研究者
Judit Pich
Clinical Research Manager
Hospital Clinic of Barcelona
研究点 (1)
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