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临床试验/NCT02381275
NCT02381275Unknown不适用

Baseline Characteristics and Long Term Clinical Outcomes of Patients Using Malawi's New First Line Antiretroviral Regimen at Lighthouse: The Lighthouse Tenofovir Cohort

Lighthouse Trust1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2014年8月14日最近更新:
适应症
相关药物

试验速览

阶段
不适用
入组人数
1,500
试验地点
1
主要终点
Proportion of HIV-infected individuals with renal dysfunction

研究概览

简要总结

Lighthouse, in cooperation with the University Heidelberg Public Health Institute and the University Köln (Cologne) would like to set up a cohort to study baseline characteristics and long-term clinical outcomes of patients using Tenofovir based Antiretroviral Therapy at the Lighthouse. As of March 2014, patients above 18 years and giving informed consent coming to the Lighthouse to newly initiate ART will be approached to enroll in the cohort.

The results will be disseminated both nationally at the Ministry of Health Technical Working Group (TWG), at the annual Research Dissemination and Best Practices conferences of the College of Medicine and National AIDS Commission as well as internationally. The results will also be written up for publication in appropriate peer-reviewed journals.

详细描述

The proposed observational cohort study will lead to improved identification of patients with virological failure and adverse drug effects, improved identification of relevant co-morbidities and result in better individual management. More importantly however, the results will allow estimates for the proportion of the described complications in the overall Malawian treatment cohort. This claim can be exemplified by the retrospective analysis of patients at the Lighthouse who were switched from the new 5A regimen to 6 A regimen as a result of adverse effects of Efavirenz.

The aim of this study is to describe baseline clinical characteristics and long-term outcomes of patients using Tenofovir based antiretroviral therapy at the Lighthouse Clinics. The specific objectives are outlined below:

Objective 1: To determine the prevalence of renal dysfunction at enrolment and during follow-up among adult HIV-infected individuals starting ART.

Objective 2: To determine the prevalence of Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) infections among adult HIV-infected individuals starting ART and during treatment follow-up.

Objective 3: To determine the prevalence of non-communicable co-morbidities during treatment follow-up of HIV-infected individuals starting ARTand during treatment follow-up.

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • 18 years or older
  • Able and willing to give informed consent

排除标准

  • 未提供

结局指标

主要结局

Proportion of HIV-infected individuals with renal dysfunction

时间窗: 36 months post ART initiation

Patients will be followed in the clinic up to 36 months

次要结局

  • Proportion of HIV-infected individuals with HIV/ HBV and HCV infections(36 months post ART initiation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sam Phiri, PhD, MSc, DCM

Executive Director

Lighthouse Trust

研究点 (1)

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The Lighthouse Tenofovir Cohort Study | 临床试验