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Completed

NCT Number: NCT02964767

HIV-Tb Confections Among HIV Patients

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.

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Key information

Conditions

HIV

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ART centre, Sadar Hospital

Khagaria, Bihar, 851204, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of HIV+ enrolled ART centre

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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%

Secondary outcomes

  1. Comparing CD4+ T Cell Count in HIV-Tb. and HIV Cases.

    Time frame: 12 months

    CD4 cell counts of HIV patients and HIV/co infection patients would be analysed by student T test, and p value would be estimated.

Sponsors and collaborators

Lead sponsor

Singh, Ranjan Kumar, M.D.

Indiv

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 16, 2016
Registry last updated
Oct 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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