Clinical trial NCT02964767: HIV-Tb Confections Among HIV Patients
Official title: Prevalence of HIV-Tb co Infections Among HIV Patients and Their CD4+ T Cell Status-A Single Centre Study in India
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Keywords: HIV
HIV-Tb co infection
CD4 Cell
Lead sponsor: Singh, Ranjan Kumar, M.D.
Sponsor class: INDIV
First posted: 2016-11-16
Enrollment: 219
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV population

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.

Eligibility 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

Primary outcomes:
measure: Prevalence of HIV/Tb. co Infections Among Patients of HIV Enrolled at ART Center.
timeFrame: 12 months
Secondary outcomes:
measure: Comparing CD4+ T Cell Count in HIV-Tb. and HIV Cases.
timeFrame: 12 months
Other outcomes:
Locations:
city: Khagaria
country: India
facility: ART centre, Sadar Hospital
state: Bihar
Study officials:
affiliation: Physician cum nodal officer, ART centre, Khagaria, India.
name: Ranjan K Singh, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Festenstein F, Grange JM. Tuberculosis and the acquired immune deficiency syndrome. J Appl Bacteriol. 1991 Jul;71(1):19-30. No abstract available.
citation: 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.
citation: Global Tuberculosis Report 2016, World Health Organisation, Geneva.
citation: 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