HIV Clinical Trial - HIV-Tb Confections Among HIV Patients

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02964767
Study type	Observational
Source	Singh, Ranjan Kumar, M.D.
Contact
Status	Completed
Phase	N/A
Start date	June 2015
Completion date	November 2016

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.