Latent Tuberculosis InfectionHIV-TBNCT00692809
Impact of HIV Infection on Latent Tuberculosis (TB) Among Patients With HIV-TB Co-infection
An observational study of Latent Tuberculosis Infection and HIV Infections, run by Ministry of Science and Technology, India at 1 site in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Latent Tuberculosis Infection, HIV Infections, Tuberculosis
- How many people
- 180 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2008to Mar 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: HIV+ve+LTBI HIV+ve+clinical TB HIV-ve+clinical TB Normal control
Who may be able to join
- 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
Show all 38Show fewer
- 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
Who cannot join
- 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
Show all 25Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110608
Surendra K Sharma, M.D., Ph.D, 26594415, surensk@gmail.com
Sanjeev Sinha, MD, 26594440, drsanjeevsinha2002@yahoo.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Latent Tuberculosis Infection, HIV Infections, Tuberculosis
- Keywords
- Latent tuberculosis infection, Human immunodeficiency virus, Tuberculosis, Natural Killer T Cells, Invariant Natural Killer T Cells, Regulatory T cells, Interferon-gamma
- Medical subject headings
- Latent Tuberculosis, HIV Infections, Tuberculosis, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 months
Secondary outcomes (1)
Elucidation of critical events of the cellular and molecular interactions that would be useful for developing newer therapeutic strategies and vaccination.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startJul 2008
- Primary completionMar 2010 (estimated)
- Study completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Latent Tuberculosis InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Science and Technology, India
- Sponsor type
- Other government
- Collaborators
- Indian Council of Medical Research
- Investigators
- Surendra K Sharma, M.D., Ph.D, Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692809
- Sponsor's protocol ID
- SKS/LTBI/07
- Acronym
- HIV-TB
- Status last verified
- Jun 2008
- First submitted
- 5 Jun 2008
- Last updated
- 15 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of HIV Infection on Latent TB Among Patients With HIV-TB Co-infection
- ClinicalTrials.gov ID
- NCT00692809
- Acronym / sponsor ID
- HIV-TB / SKS/LTBI/07
- Conditions
- Latent Tuberculosis Infection, HIV Infections, Tuberculosis
- Keywords
- Latent tuberculosis infection, Human immunodeficiency virus, Tuberculosis, Natural Killer T Cells, Invariant Natural Killer T Cells, Regulatory T cells, Interferon-gamma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Ministry of Science and Technology, IndiaOther government
- Collaborators
- Indian Council of Medical Research
- Study start
- Jul 2008
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 6 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- HIV+ve+LTBI HIV+ve+clinical TB HIV-ve+clinical TB Normal control
Key inclusion criteria (38 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2009.
Related trials for Latent Tuberculosis Infection
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
RecruitingObservational study
Training Protocol on the Natural History of Tuberculosis
Mycobacterium Infections, Tuberculosis, Multidrug-Resistant
RecruitingPhase 2/3
Bedaquiline Roll-out Evidence in Contacts and People Living With HIV to Prevent TB
Tuberculosis, Latent
RecruitingPhase 2
BPaLMZ for TB Meningitis
Tuberculous Meningitis, HIV
Recruiting
Screening With Portable X-rays for Rapid Recognition of TB
Tuberculosis (TB), Tuberculosis Infection, Latent
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Surendra K Sharma, M.D., Ph.D principal investigator
All India Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Latent Tuberculosis Infection and HIV Infections, run by Ministry of Science and Technology, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 38 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Surendra K Sharma, M.D., Ph.D (26594415, surensk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2009.