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临床试验/NCT02964767
NCT02964767已完成不适用

Prevalence of HIV-Tb co Infections Among HIV Patients and Their CD4+ T Cell Status-A Single Centre Study in India

Singh, Ranjan Kumar, M.D.1 个研究点 分布在 1 个国家目标入组 219 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
219
试验地点
1
主要终点
Prevalence of HIV/Tb. co Infections Among Patients of HIV Enrolled at ART Center.

研究概览

简要总结

A cross sectional study would be done for prevalence of HIV-Tb. co infection among patients of HIV enrolled at ART centre, Khagaria, India, during June' 2015 to May' 2016. A comparative study of CD4 (cluster of differentiation 4) T cell count among HIV-Tb. co infected patient and HIV patients would be taken in account.

详细描述

Introduction

HIV infection increases the susceptibility of Mycobacterium Tuberculosis (M.Tb.) infection, and hastens its progression due to changes in immune status of the patients. In fact, tuberculosis is now the most common opportunistic infection in patients, who die from AIDS. Immune response in tuberculosis and other infections induces cytokines that enhance replication of HIV, and derives the patient to full blown AIDS. the prevalence of HIV/Tb co-infections have been reported to 0.4% to 20.1% from different regions of northern part of india. India is one of the six countries, those are accounted for 60 percent new cases of tuberculosis, and the BRICS countries collectively account for approximately 50 perce

nt cases of worldwide tuberculosis. The prevalence of multidrug resistant tuberculosis(MDR-TB.) is two-threefold higher in HIV co-infected patients; as HIV infected people rapidly acquire the active disease including resistant strain of M. Tb. and rapidly transmit the disease among population including PLHIV, who in turn, manifest the active drug resistant tuberculosis.

Methods

  • This is cohort study among patients of HIV, attending ART (Antiretroviral therapy) center khagaria, Bihar, India during June' 2015 to May' 2016.
  • Patients enrolled at the centre were subjected to screening for Mycobacterium tuberculosis infection by doing ESR, mantoux test, chest x-ray, sputum examination for acid fast bacillus (AFB) and nucleic acid amplification test.
  • HIV/Tb co infected patients were given cotrimoxazole.
  • Patients' data-for example, age, sex, co infection with tuberculosis would be recorded.
  • Sputum positivity, radiological features, and extra pulmonary manifestations would be recorded and statistical analysis would be done
  • Statistical analysis, such as, mean, standard deviation(SD), student T test, p-values would be done. P-value significance would be measured at p < .05.

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
5 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of HIV+ enrolled ART centre

排除标准

  • Lost to follow up patients (LFU)
  • Patients died before the treatment started
  • Children below 5 years

结局指标

主要结局

Prevalence of HIV/Tb. co Infections Among Patients of HIV Enrolled at ART Center.

时间窗: 12 months

% Prevalence of HIV/Tb. co infections= no.of HIV/Tb. co infection (48)/total no. of enrolled patients of HIV including HIV/Tb. co infections (219) x 100, i.e. 21.9%

次要结局

  • Comparing CD4+ T Cell Count in HIV-Tb. and HIV Cases.(12 months)

研究者

发起方
Singh, Ranjan Kumar, M.D.
申办方类型
Indiv
责任方
Principal Investigator
主要研究者

Ranjan Kumar Singh

Nodal officer of ART centre, Sadar Hospital.

Singh, Ranjan Kumar, M.D.

研究点 (1)

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