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Sponsors and Collaborators: |
All India Institute of Medical Sciences, New Delhi Indian Council of Medical Research Ministry of Science and Technology, India |
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Information provided by: | All India Institute of Medical Sciences, New Delhi |
ClinicalTrials.gov Identifier: | NCT00692809 |
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.
Condition |
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Latent Tuberculosis Infection HIV Infections Tuberculosis |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Impact of HIV Infection on Latent TB Among Patients With HIV-TB Co-Infection |
Estimated Enrollment: | 180 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
HIV+ve+LTBI (n=100)
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HIV+ve+clinical TB (n=50)
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HIV-ve+clinical TB (n=15)
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Normal control (n=15)
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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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
HIV+ve+LTBI HIV+ve+clinical TB HIV-ve+clinical TB Normal control
Inclusion Criteria:
HIV infected +LTBI group:
HIV infected + Clinical TB group:
In EPTB group, diagnosis of TB will be:
HIV negative Clinical TB group:
In EPTB group, diagnosis of TB will be:
Normal controls:
Person should not have past history of TB
Exclusion Criteria:
HIV infected +LTBI group:
HIV infected + Clinical TB group:
HIV negative Clinical TB group:
Normal controls:
Contact: Surendra K Sharma, M.D., Ph.D | 26594415 | surensk@gmail.com |
India, Delhi | |
All India Institute of Medical Sciences | |
New Delhi, Delhi, India, 110608 |
Principal Investigator: | Surendra K Sharma, M.D., Ph.D | All India Institute of Medical Sciences, New Delhi |
Responsible Party: | All India Institute of Medical Sciences ( Dr. S.K. Sharma, Professor & Head ) |
Study ID Numbers: | SKS/LTBI/07 |
Study First Received: | June 5, 2008 |
Last Updated: | June 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00692809 |
Health Authority: | India: Institutional Review Board |
Latent tuberculosis infection Human immunodeficiency virus Tuberculosis Natural Killer T Cells |
Invariant Natural Killer T Cells Regulatory T cells Interferon-gamma |
Bacterial Infections Sexually Transmitted Diseases, Viral Interferon Type II Acquired Immunodeficiency Syndrome Interferons Immunologic Deficiency Syndromes Virus Diseases |
Gram-Positive Bacterial Infections HIV Infections Sexually Transmitted Diseases Mycobacterium Infections Tuberculosis Retroviridae Infections Interferon-gamma, Recombinant |
Communicable Diseases RNA Virus Infections Slow Virus Diseases Immune System Diseases |
Lentivirus Infections Infection Actinomycetales Infections |