Multicentre, Open-label, Post-approval Observational Study of Elpida® Used in the First Line Therapy for HIV-1 Infected Patients With the Background of Standard Baseline ART (NNRTI + 2 NRTIs)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,000
- 试验地点
- 10
- 主要终点
- Incidence of AEs and SAEs
研究概览
简要总结
This post-registration observational study is designed to monitor the safety parameters and efficacy of Elpida® in actual practice in the first-line treatment of HIV-1 infected patients on the background of the standard baseline ART.
详细描述
This study is a multicenter, open-label, post-registration observational non-interventional study of the use of Elpida® in the first line of therapy for HIV-1 infected patients against a background of standard baseline ART (NNRTIs + 2 NRTIs). The study is scheduled to be conducted approximately in 20 centers for the prevention and control of AIDS in Russia.
In total, 2000 HIV-1-infected patients who are prescribed therapy with Elpida® (20 mg capsules) against the background of standard baseline ART are planned to be included in the study.
The observational study will collect data from patients who signed informed consent and meet all inclusion/non-inclusion criteria from the time that precedes the therapy by Elpida® up to 96 weeks of treatment or until early elimination. The data will be obtained through routine visits and procedures, including demographics and history, height, body weight, body mass index (BMI), laboratory data (viral load of HIV-1, CD4+-T-lymphocytes, resistance mutations in HIV-1, screening for hepatitis B and C, syphilis, general and biochemical blood analysis, general urine analysis) and instrumental examinations (electrocardiography (ECG), chest X-ray/fluorography). Throughout the study, patients will keep observation diaries for recording AEs and concomitant therapy. Data on the intake of ART drugs and AE related to their use will also be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •A signed patient information sheet and a form of informed consent to participate in the study.
- •Men and women aged 18 and over.
- •Document supported HIV-1 infection.
- •Patients whom during the previous 24 weeks first line ART was prescried comprising the drug Elpida®, including patients who are ART-naive or were transferred to Elpida® from other first line ART regimens due to intolerance (transfer from other NNRTIs - within the class; transfer from protease inhibitors, including boosted ones, due to lipid metabolism disorders or other adverse reactions (AR) if the virological effectiveness of the previous ART regimen - was effective - reaching undetectable levels of viral load).
排除标准
- •Current participation in the clinical trial.
- •Significant alcohol and/(or) drug dependence, which, according to the researcher, can prevent collection of data.
- •Increase of AST/ALT levels by more than 2.5 times higher than the upper limit of the reference range at Week 0 visit.
- •Replication stage of chronic hepatitis C (presence of HCV RNA), requiring therapy.
- •Use of Elpida® in violation of indications officially approved by the Ministry of Health of the Russian Federation on the package leaflet.
- •Significant secondary diseases requiring treatment.
研究组 & 干预措施
Elpida® + 2 NRTIs
Elpida® 20mg qd in the first line of therapy for HIV-1 infected patients with a background standard ART.
干预措施: Elpida® + 2 NRTIs (Drug)
结局指标
主要结局
Incidence of AEs and SAEs
时间窗: 96 weeks
Incidence of adverse events (AEs) and serious adverse events (SAEs)
次要结局
- Proportion of patients with undetectable viral load on visits, starting from Week 24(24 weeks)
- The frequency of virological failures(96 weks)
- Viral load(96 weeks)
- Absolute CD8+ lymphocytes count(96 weeks)
- The percent of patients who developed HIV-1 resistance to Elpida®(96 weeks)