跳至主要内容
临床试验/CTRI/2018/12/016519
CTRI/2018/12/016519招募中不适用

A study on the prevalence and characteristics of tuberculosis in people living with HIV in a tertiary care hospital

Kasturba Hospitals1 个研究点 分布在 1 个国家目标入组 249 人开始时间: 2018年4月12日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
249
试验地点
1
主要终点
Prevalence of tuberculosis in PL-HIV

研究概览

简要总结

Tuberculosis is the most common opportunistic infection and the most common cause of mortality in PL-HIV. This is a study targeting this co-epidemic, with the objective of assessing the prevalence and characteristics of tuberculosis in PL-HIV, stratified by their CD-4 count, presenting to a tertiary care hospital. Informed consent will be obtained from both newly diagnosed and previously diagnosed people living with HIV under the care of the Department of General Medicine, and will be recruited under the study based on the inclusion and exclusion criteria

Data will be collected on the socio-demographic, clinical and laboratory characteristics  of the patients, using a structured proforma. Past history of tuberculosis will also be recorded. The test records captured to ascertain tuberculosis are a part of the standard of care. No additional tests will be done as a part of the study. The data collected will be analysed and the prevalence and characteristics of tuberculosis will be measured and stratified based on CD4 count status of the patient. As a second objective, the practice of Isoniazid prophylactic therapy in people living with HIV and its outcomes is also being studied. The study participants who are on IPT (started as a part of the standard of care) will be followed up to assess the outcome of the same, for a duration of 6 months.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • All patients who are either newly diagnosed with HIV or previously diagnosed people living with HIV, under the care of Kasturba Hospitals.

排除标准

  • All pediatric HIV patients; any patient fulfilling the inclusion criteria, but who do not have CD4 counts tested in the last 6 months.

结局指标

主要结局

Prevalence of tuberculosis in PL-HIV

时间窗: At the time of seeing the patient (day 0)

次要结局

  • Practice of Isoniazid Prophylactic Therapy in PL-HIV(0, 3 months and 6 months)

研究者

发起方
Kasturba Hospitals
申办方类型
Private medical college

研究点 (1)

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