Status:
UNKNOWN
Impact of HIV Infection on Latent Tuberculosis (TB) Among Patients With HIV-TB Co-infection
Lead Sponsor:
Ministry of Science and Technology, India
Collaborating Sponsors:
Indian Council of Medical Research
Conditions:
Latent Tuberculosis Infection
HIV Infections
Eligibility:
All Genders
18-65 years
Brief 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 faste...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2010
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00692809
Start Date
July 1 2008
End Date
March 1 2010
Last Update
September 15 2009
Active Locations (1)
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1
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India, 110608