HIV-TBImpact of HIV Infection on Latent TB Among Patients With HIV-TB Co-infection
Data Collection
Collected from today forward - ProspectiveLatent Infection+21
+ Blood-Borne Infections
+ Urogenital Diseases
Summary
Study start date: July 1, 2008
Actual date on which the first participant was enrolled.During the natural course of HIV disease, emergence of opportunistic infection not only imposes morbidity on HIV-TB co-infected patients, but also facilitates viral replication causing faster disease progression. Tuberculosis, being the commonest among the opportunistic infections among HIV infected persons deserves special attention. Moreover, disruption of latency of TB infection (LTBI) with development of more severe clinical forms at relatively early stage of HIV disease when CD4 count still remains above 300/ul, makes TB a unique opportunistic infection and negatively influence the outcome of dual infection.This is suggestive of impairment of some critical immune function involving relatively less frequent fine T cell subsets with functional hierarchy over bulk T cells, so as to weaken the immune containment of LTBI resulting in reactivation of M. tuberculosis and manifestation of severe forms of TB.HIV has recently been reported to preferentially infect, destroy and incapacitate two key immune-regulatory T cell subsets, namely NKT and Treg cells.Therefore, studying them along the course of HIV disease and impact of their changes on the function of effector T cells directed against M.tuberculosis is important.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.180 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: HIV infected +LTBI group: * Patient of either sex between 18-65 years of age * All the patients should be HIV ELISA test positive irrespective of CD4 count and presence of other opportunistic infections Antiretroviral drug naive HIV patients * No past history of TB * Patients should be either tuberculin test positive (\> 5mm) or interferon gamma release assay positive * Written informed consent to participate in the study given by participants or legal guardian * Patients able to comply with instructions and come back for a regular follow up HIV infected + Clinical TB group: * Patient of either sex between 18-65 years of age * All the patients should be HIV ELISA test positive irrespective of CD4 count and presence of other opportunistic infections * In PTB group, patient should be two sputum smear positive out of three consecutive samples * In EPTB group, diagnosis of TB will be: * Definitive -Culture confirmed * Probable -Histopathological or radiological -Clinical features and response to anti TB treatment (ATT) * Possible TB -Clinical feature and response to anti TB treatment (ATT) * Written informed consent to participate in the study given by participants or legal guardian * Patients able to comply with instructions and come back for a regular follow up HIV negative Clinical TB group: * Patients of either sex between 18-65 years of age who are permanent resident of Delhi * All patients should be HIV ELISA negative * In PTB group, patients should be two sputum smear positive (at least 1+) out of three consecutive samples * In EPTB group, diagnosis of TB will be: * Definitive -Culture-confirmed * Probable -Histopathological or radiological -Clinical features and response to anti-TB treatment (ATT) * Possible TB -Clinical features and response to anti-TB treatment (ATT) * Written informed consent to participate in the study given by participants or legal guardian * Patients able to comply with instructions and come back for a regular follow up Normal controls: * Persons of either sex between 18-65 years of age who are permanent resident of Delhi * Written informed consent to participate in the study given by participants or legal guardian * Person should not have past history of TB * Mantoux test negative (\< 10mm) * Chest-X-ray normal * Hemogram normal * Renal and liver functions normal * Hepatitis viral markers normal * No clinical evidence of malnutrition * HIV ELISA negative Exclusion Criteria: HIV infected +LTBI group: * Pregnant and lactating females * Patients who are getting steroid therapy * Transplant patients, diabetes mellitus or malignancy, chronic renal failure or liver diseases * Currently receiving cytotoxic therapy, or have received it within the last 3 months * Terminally ill as per treating clinician's judgment * Patient from outside Delhi and migrants HIV infected + Clinical TB group: * Category II and multidrug-resistant pulmonary tuberculosis * Pregnant and lactating females * Patients who are getting steroid therapy * Transplant patients, diabetes mellitus or malignancy, chronic renal failure or liver diseases * Currently receiving cytotoxic therapy, or have received it within the last 3 months * Terminally ill patient as per treating clinician's judgment * Patients from outside Delhi and migrants HIV negative Clinical TB group: * Category II and multi drug-resistant pulmonary tuberculosis * Patients who are getting steroid therapy * Transplant patients, diabetes mellitus or malignancy, chronic renal failure or liver disease * Currently receiving cytotoxic therapy, or have received it within the last 3 months * Terminally ill patient as per treating clinician's judgment * Patients unwilling to comply with the study procedures or those with history of alcohol or drug abuse Normal controls: * Transplant patients, diabetes mellitus or malignancy * Patients unwilling to comply with the study procedures or those with history of alcohol or drug abuse
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
All India Institute of Medical Sciences
New Delhi, IndiaOpen All India Institute of Medical Sciences in Google Maps