HIV-Tb Confections Among HIV Patients

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

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 219

Contacts and Locations

Study Locations

• India
  • Bihar
    • Khagaria, Bihar, India, 851204
      • ART centre, Sadar Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HIV population

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of HIV/Tb. co Infections Among Patients of HIV Enrolled at ART Center.	% 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%	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparing CD4+ T Cell Count in HIV-Tb. and HIV Cases.	CD4 cell counts of HIV patients and HIV/co infection patients would be analysed by student T test, and p value would be estimated.	12 months

Collaborators and Investigators

• Sponsor: Singh, Ranjan Kumar, M.D.
• Investigators: Principal Investigator: Ranjan K Singh, M.D., Physician cum nodal officer, ART centre, Khagaria, India.

Publications and helpful links

General Publications

• Getahun H, Gunneberg C, Granich R, Nunn P. HIV infection-associated tuberculosis: the epidemiology and the response. Clin Infect Dis. 2010 May 15;50 Suppl 3:S201-7. doi: 10.1086/651492.
• Festenstein F, Grange JM. Tuberculosis and the acquired immune deficiency syndrome. J Appl Bacteriol. 1991 Jul;71(1):19-30. No abstract available.
• 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

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: November 5, 2016
• First Submitted That Met QC Criteria: November 15, 2016
• First Posted (Estimate): November 16, 2016

Study Record Updates

• Last Update Posted (Actual): October 4, 2017
• Last Update Submitted That Met QC Criteria: September 6, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: HIV; CD4 Cell; HIV-Tb co infection
• Additional Relevant MeSH Terms: Infections; Coinfection
• Other Study ID Numbers: SinghRK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Study Data/Documents

1. Epidemiological report
2. Clinical Study Report