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临床试验/NCT01853657
NCT01853657Unknown不适用

Efficacy of First and Second Line ART in HIV Patients Treated at the Komfo Anokye Teaching Hospital, Kumasi

Bernhard Nocht Institute for Tropical Medicine1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2012年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
3,000
试验地点
1
主要终点
Clinical failure

研究概览

简要总结

The main objective is to access efficacy of first and second line antiretroviral therapy (ART) and its determinants in patients treated at the Komfo Anokye Teaching Hospital in Kumasi (KATH), Ghana, and to compare the clinical, virological and immunological efficacy of second line ART in patients who were switched after virological failure compared to patients who were switched after clinical or immunological failure.

Other specific study objectives are:

  1. To establish an HIV Cohort Study at the study site.
  2. To assess the rate of virological failure among patients on first line therapy
  3. To compare the clinical, immunological and virological efficacy of second line antiretroviral therapy amongst patients randomised to virological monitoring whilst on first line compared with those monitored routinely using clinical and immunological monitoring.
  4. To assess the incidence and outcome of tuberculosis (TB) and other opportunistic infections in patients treated at the Komfo Anokye Teaching Hospital HIV services
  5. To obtain parameters for quality of care, e. g. performance of TB screening procedures
  6. To develop strategies to minimise treatment failures, on the basis of the results of the study
  7. To generate a large prospective second-line ART cohort, to serve as basis for further research projects
  8. To implement point-of-care viral load analysis at the Komfo Anokye Teaching Hospital
  9. Capacity building: epidemiology, medical documentation and data base management. Enrollment of one PhD and one Master student

详细描述

Study design:

Open randomized study

Recruitment:

All patients being on stable ART for at least one year will be asked to participate in the study after thorough information about the objectives/procedures of the study and associated inconveniences/risks. After informed consent has been given, patients will be asked to complete a short questionnaire on their history of antiretroviral therapy, including information on drug adherence, reliability of drug supply, side effects and complications of highly active antiretroviral therapy (HAART). Data on the socioeconomic status, perceived difficulties related to antiretroviral therapy and subjective quality of care and support offered by the HIV treatment program will be documented.

Randomization:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
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

入选标准

  • able and willing to give informed written consent
  • age > 18 years
  • on first line ART since > 12 months

排除标准

  • not willing or able to comply with study procedures

结局指标

主要结局

Clinical failure

时间窗: 12 and 24 months

Combined endpoint is clinical failure 12 and 24 months after switch to second line treatment, defined as: 1. First/new AIDS defining event 2. Death

次要结局

  • CD4 response(12 and 24 months)

研究者

发起方
Bernhard Nocht Institute for Tropical Medicine
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Kirsten A. Eberhardt

Dr., MD

Bernhard Nocht Institute for Tropical Medicine

研究点 (1)

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