HIV-Tb Confections Among HIV Patients

Completed

• Conditions: HIV

• Registration Number: NCT02964767
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-06
• Primary Completion: 2016-05
• Study Completion: 2016-11
• Study First Submitted: 2016-11-05
• Study First Submitted QC: 2016-11-15
• Study First Posted: 2016-11-16
• Results First Submitted: 2017-01-23
• Results First Submitted QC: 2017-04-28
• Results First Posted: 2017-08-07
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-06
• Last Update Posted: 2017-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 219

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Name	Time	Method
Comparing CD4+ T Cell Count in HIV-Tb. and HIV Cases.	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.

Trial Locations

Locations (1)

ART centre, Sadar Hospital; 🇮🇳 Khagaria, Bihar, India