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
|Condition or disease|
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.
- 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|
|Actual Enrollment :||219 participants|
|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|
HIV mono infection
HIV Patients do not have active Mycobacterium Tuberculosis infection
HIV-Tb. co infection
Patients with HIV and MycobacteriumTuberculosis co infections
- 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%
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02964767
|ART centre, Sadar Hospital|
|Khagaria, Bihar, India, 851204|
|Principal Investigator:||Ranjan K Singh, M.D.||Physician cum nodal officer, ART centre, Khagaria, India.|