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临床试验/NCT04253119
NCT04253119已完成不适用

Retrospective Evaluation of Treatment Durability Among Treatment-naive HIV-infected Individuals Initiated First-line ART in Russia

MSD Pharmaceuticals LLC4 个研究点 分布在 1 个国家目标入组 536 人开始时间: 2019年11月26日最近更新:
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试验速览

阶段
不适用
状态
已完成
入组人数
536
试验地点
4
主要终点
48 Weeks Treatment Durability

研究概览

简要总结

This study is a non-interventional retrospective study. Data from patients who signed informed consent form will be collected through retrospective chart or medical records review. Patients have been receiving treatment and diagnostic procedures according to daily clinical practice conducted by his/her physician. There are no procedures that are required as part of this study.

The study is to be conducted in 6 investigational sites across Russia with up to 200 patients recruited per site.

HIV-infected patients with no experience of therapy at time of initiation of ART with NNRTI plus two NRTIs or PI boosted by ritonavir with 2 NRTIs will be enrolled and followed retrospectively for up to 96 weeks with data collection at the approximate time points of baseline (pre-treatment) and at 48 and 96 weeks after start of treatment.

The following ARV drugs are considered according to the standards of care:

  • NNRTIs: efavirenz (EFV), nevirapine (NVP), rilpivirine (RPV), ETR (etravirine)
  • PIs: LPV (lopinavir), DRV (darunavir), ATV (atazanavir), FPV (fosamprenavir)

详细描述

All patients must have initiated ART between February 01 and April 30, 2017. A time window for the retrospective visits at baseline, 48 and 96 weeks is envisaged as approximately ± 8 weeks.

Patients will be retrospectively screened and selected according to inclusion and exclusion criteria prior to enrollment in each investigational site starting the day of its initiation. The study sites will maintain a list of all screened patients. All patients eligible according to the inclusion/exclusion criteria and after signing the informed consent form are to be consequently enrolled for their demographic and clinical data collection through retrospective chart or medical records review. The enrollment will continue until the recruitment goal is reached.

Baseline and follow-up data will be extracted through retrospective chart or medical records review, if available at each investigational site. No additional interventional testsor medical procedures such as additional blood samples, X-ray or other technical investigations will be performed as a part of this study. If any data element is not available, it will be reported as missing.

At baseline, demographic and clinical data on age, gender, employment status, marital status, substance abuse, HIV diagnosis duration, route of infection, AIDS stage, viral load, CD4 count, concomitant medication, comorbidities (noted diagnosis by physician) are to be collected through retrospective chart or medical records review.

At 48 and 96 weeks of retrospective follow-up, the investigators will assess through the medical records whether the patient was still on treatment with initiated ART (NNRTI, PI) and evaluate the estimated time on therapy without change of the NNRTI or PI agent within the class or without change of the NNRTI or PI agent to a different class.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (>18 years of age) with definite HIV-1 infection based on positive lab test and judgement of treating physician according to standards of care
  • Naive to antiretroviral treatment at the time of initiation
  • Viral load of >1000 copies/ml at the time of initiation of ART
  • Initiated their first-line ART between February 01 and April 30, 2017
  • Patients are included, if the third component of their first line ART was either NNRTI or boosted PI plus NRTIs
  • Completed follow-up from baseline for at least 96 weeks
  • Signed informed consent

排除标准

  • HIV-2 infection

结局指标

主要结局

48 Weeks Treatment Durability

时间窗: 48 weeks

Percentage of patients remained on initial therapy without change of the NNRTI or PI agent

次要结局

  • Time on Therapy at 48 Weeks(48 weeks)
  • Time on Therapy at 96 Weeks(96 weeks)
  • 96 Weeks Treatment Durability(96 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (4)

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