NCT03333083终止3 期
Phase 3b, Single Arm, Simplification Study With Dual Therapy Including Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) in Virologically Suppressed HIV-1 Infected Patients Experiencing Inconvenience, Toxicity, Negative Impact on Co-morbidities or Risk of Drug-drug Interactions With Their Current Regimen. (RALAM-II Study)
Judit Pich1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2018年5月3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
- 终止
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Therapeutic failure
研究概览
简要总结
Phase 3b, single arm, simplification study with dual therapy including Lamivudine (300 mg QD) plus Raltegravir (1200 mg QD) in virologically suppressed HIV-1 infected patients experiencing inconvenience, toxicity, negative impact on comorbidities or risk of drug-drug interactions with their current regimen.
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
- •Eligible patients will be males or females at least 18 years of age. Women of childbearing potential must have a negative pregnancy test within 10 days prior to randomization into the study.
- •Patients seropositive for HIV-1 using standard diagnostic criteria.
- •Patients experiencing inconvenience, toxicity, negative impact on comorbidities or risk of drug-drug interactions with their current regimen
- •Patients virologically suppressed during at least 12 months prior to inclusion (viral load <50 copies/mL).
- •Patients who have signed informed consent to participate in the study.
排除标准
- •Pregnancy, lactation, or planned pregnancy during the study period.
- •Previous failure to an integrase inhibitor-containing regimen.
- •Previous failure to a Lamivudine or Emtricitabine-containing regimen.
- •Resistance mutations to Lamivudine or integrase inhibitor if any resistance test had been previously performed.
- •Any disease or history of disease which, in the opinion of the investigator, might confound the results of the study or pose additional risk to patient treatment.
- •Chronic hepatitis B.
研究组 & 干预措施
Raltegravir + Lamivudine
Experimental
干预措施: Raltegravir (Drug)
Raltegravir + Lamivudine
Experimental
干预措施: Lamivudine (Drug)
结局指标
主要结局
Therapeutic failure
时间窗: 48 weeks
therapeutic failure at week 48, includes virological failure, change in treatment for any reason, consent withdrawal, loss to follow-up or death
次要结局
- Changes from baseline in and insulin resistance (HOMA-IR)(48 weeks)
- Changes from baseline in body fat composition(48 weeks)
- Changes from baseline in immune activation markers including CD38(48 weeks)
- Changes from baseline in cholesterol total(48 weeks)
- Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was inconenience(48 weeks)
- Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was neurological toxicity(48 weeks)
- Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was cardiovascular toxicity or co-morbidity(48 weeks)
- Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was skeletal toxicity(48 weeks)
- Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was digestive toxicity(48 weeks)
- Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was drug-drug interactions(48 weeks)
- Therapeutic failure(24 weeks)
- Virological failure(48 weeks)
- Proportion of patients with viral load below ultrasensitive HIV-1 RNA detection limit (limit of detection 1 copy/mL)(48 weeks)
- Changes from baseline in immune activation markers including HLA-DR(48 weeks)
- Changes from baseline in biomarkers of inflammation IL-6,(48 weeks)
- Changes from baseline in HDL(24 weeks)
- Changes from baseline in triglycerides(48 weeks)
- Changes from baseline in insulin resistance (HOMA-IR)(24 weeks)
- Changes from baseline in cholesterol LDL(48 weeks)
- Changes from baseline in cholesterol HDL(48 weeks)
- Changes from baseline in biomarkers of inflammation high sensitivity C-reactive protein(48 weeks)
- Changes from baseline in biomarkers of mononuclear activation SD-14(48 weeks)
- Changes from baseline in biomarkers of mononuclear activation SD-163(48 weeks)
- Changes from baseline in sleep quality (Pittsburgh Sleep Quality Index)(48 weeks)
- Change from baseline in EQ-5D-5L(48 weeks)
- Incidence of adverse events(48 weeks)
研究者
Judit Pich
Clinical Research Manager
Hospital Clinic of Barcelona
研究点 (1)
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