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HIV-Tb Confections Among HIV Patients

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ClinicalTrials.gov Identifier: NCT02964767
Recruitment Status : Completed
First Posted : November 16, 2016
Results First Posted : August 7, 2017
Last Update Posted : October 4, 2017
Sponsor:
Information provided by (Responsible Party):
Ranjan Kumar Singh, Singh, Ranjan Kumar, M.D.

Brief Summary:
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.

Condition or disease
HIV

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 219 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of HIV-Tb co Infections Among HIV Patients and Their CD4+ T Cell Status-A Single Centre Study in India
Study Start Date : June 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort
HIV mono infection
HIV Patients do not have active Mycobacterium Tuberculosis infection
HIV-Tb. co infection
Patients with HIV and MycobacteriumTuberculosis co infections



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV population
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02964767


Locations
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India
ART centre, Sadar Hospital
Khagaria, Bihar, India, 851204
Sponsors and Collaborators
Singh, Ranjan Kumar, M.D.
Investigators
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Principal Investigator: Ranjan K Singh, M.D. Physician cum nodal officer, ART centre, Khagaria, India.

Study Data/Documents: Epidemiological report  This link exits the ClinicalTrials.gov site

Publications:
Global Tuberculosis Report 2016, World Health Organisation, Geneva.
Perrin F, Breen R, Lipman M. : HIV and Tuberculosis co-infection. ABC of HIV and AIDS. Michael W, et al (ed): Wiley-Blackwell, BMJ Publishing Group Limited 6:42-47,2012

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Responsible Party: Ranjan Kumar Singh, Nodal officer of ART centre, Sadar Hospital., Singh, Ranjan Kumar, M.D.
ClinicalTrials.gov Identifier: NCT02964767     History of Changes
Other Study ID Numbers: SinghRK
First Posted: November 16, 2016    Key Record Dates
Results First Posted: August 7, 2017
Last Update Posted: October 4, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Ranjan Kumar Singh, Singh, Ranjan Kumar, M.D.:
HIV
HIV-Tb co infection
CD4 Cell

Additional relevant MeSH terms:
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Coinfection
Infection
Virus Diseases
Parasitic Diseases