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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ministry of Science and Technology, India

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Indian Council of Medical Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2008

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2010

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 6, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings