Impact of HIV Infection on Latent Tuberculosis (TB) Among Patients With HIV-TB Co-infection (HIV-TB)

September 14, 2009 updated by: Ministry of Science and Technology, India

Impact of HIV Infection on Latent TB Among Patients With HIV-TB Co-infection

HIV induced altered representation and function of regulatory T cell subsets (NKT and Treg cells) impair the protective T cell response against M.tuberculosis and disrupts LTBI, thus facilitates faster progression and development of severe forms of clinical TB in HIV-TB co-infection.

Study Overview

Status

Unknown

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Surendra K Sharma, M.D., Ph.D
  • Phone Number: 26594415
  • Email: surensk@gmail.com

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110608
        • Recruiting
        • All India Institute of Medical Sciences
        • Contact:
        • Contact:
        • Principal Investigator:
          • Surendra K Sharma, M.D., Ph.D
        • Sub-Investigator:
          • Sanjeev Sinha, MD
        • Principal Investigator:
          • Dipender K Mitra, Ph.D
        • Sub-Investigator:
          • Amit K Dinda, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

HIV+ve+LTBI HIV+ve+clinical TB HIV-ve+clinical TB Normal control

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
1
HIV+ve+LTBI (n=100)
2
HIV+ve+clinical TB (n=50)
3
HIV-ve+clinical TB (n=15)
4
Normal control (n=15)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Precise component(s) of T cell response against M.tuberculosis compromised by HIV infection which leads to the development of severe forms of clinical tuberculosis.
Time Frame: 5 months
5 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Elucidation of critical events of the cellular and molecular interactions that would be useful for developing newer therapeutic strategies and vaccination.
Time Frame: 5 months
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ministry of Science and Technology, India

Collaborators

Indian Council of Medical Research

Investigators

  • Principal Investigator: Surendra K Sharma, M.D., Ph.D, All India Institute of Medical Sciences, New Delhi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Anticipated)

March 1, 2010

Study Completion (Anticipated)

March 1, 2010

Study Registration Dates

First Submitted

June 5, 2008

First Submitted That Met QC Criteria

June 5, 2008

First Posted (Estimate)

June 6, 2008

Study Record Updates

Last Update Posted (Estimate)

September 15, 2009

Last Update Submitted That Met QC Criteria

September 14, 2009

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SKS/LTBI/07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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