Research

This program builds upon 20 years of productive NIH-supported, HIV research collaborations. Much of the credit for the success of this two decade Indo-US HIV-research partnership in Pune lies with the Hopkins Fogarty AIDS International Training and Research Program (AITRP) in India. This program also specifically leverages the long-standing Hopkins HIV research capacity and partnerships with the NIH-supported BJMC Clinical Trials Unit (CTU), which is conducting a broad range of HIV research and now seeks to build and expand new research capacity focused on studies of HIV-TB co-infection. The sections below highlight some of the current projects that have developed because of this partnership.

  • A Prospective Study Evaluating the Role of Cryptococcal Antigen Screening Among HIV-infected Adults

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    This study seeks to evaluate the burden of Crptococcal disease among HIV-infected adults with low CD4 cell counts.

  • A Prospective Study Evaluating the Role of Cryptococcal Antigen Screening Among HIV-infected Adults

    Project

    A Prospective Study Evaluating the Role of Cryptococcal Antigen Screening Among HIV-infected Adults with Low CD4 Counts

    P.I.

    Amita Gupta, Vidya Mave, Dileep Kadam

    Collaborators

    CCHGE, BJGMC

    Study Type

    Prospective observational study

    Primary Aims

    To assess the prevalence of asymptomatic cyrptoccemia

    Sample Size

    ~200 HIV infected adults

    Duration

    2011-2014

    Contact Information

    vidyamave@gmail.com

    The aims of this study are to 1) evaluate the burden of Cryptococcal disease among HIV-infected adults with low CD4 cell counts in Pune, India by conducting Cryptococcal antigen screening, and 2) determine whether a Cryptococcal screening strategy should be the standard of care in patients with advanced HIV disease who are admitted to medicine wards or are seen as new patients in the ART center.

  • Barriers to implementation of Isoniazid preventive treatment (IPT) in pediatric contacts

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    Young children infected with M.tuberculosis can rapidly progress to pulmonary and extrapulmonary disease with high rates of mortality and morbidity. Studies worldwide have demonstrated that IPT not only prevents latent and asymptomatic TB from progression to clinical disease but also effectively prevents initial infection (11). Despite a strong body of evidence and recommendations from WHO and RNTCP, there appears to be a wide gap between the policy and practice of IPT implementation. Study findings would aid in the planning of procurement and distribution of isoniazid to avoid shortages. Further, the study will determine if IPT is being implemented according to RNTCP guidelines. Most importantly, this study expect to identify modifiable and non- modifiable barriers and challenges to optimal implementation of IPT which can help assess the situation in other parts of India and facilitate the initiation of corrective measures.

  • Barriers to implementation of Isoniazid preventive treatment (IPT) in pediatric contacts

    Study Title

    Barriers to implementation of Isoniazid preventive treatment (IPT) in pediatric contacts of sputum positive adults with tuberculosis

    PI

    Dr. Vasudha A Belgaumkar

    Study Type

    Cross -sectional study

    Primary Aims

    Observational Study

    Primary Aims

    Primary Objectives:
    1. To determine whether isoniazid preventive therapy (IPT) is being provided to childhood contacts of sputum positive adults with tuberculosis according to RNTCP guidelines at Sassoon General Hospital, Pune.
    2. To document the barriers to delivery and uptake of IPT (to childhood contacts of sputum positive adults with tuberculosis) according to RNTCP guidelines at Sassoon General Hospital, Pune from provider and user perspectives.

    Secondary Objectives:
    1. To estimate the number of child contacts of sputum smear positive TB eligible for IPT under   RNTCP.

    Sample Size

    125 child contacts

    40 Health Care Provider (HCP)

    Duration

    January 2016 to June 2016

    Contact

    doc_vasudha@yahoo.co.in

  • Barriers to Treatment Initiation in Childhood Tuberculosis in a high incidence setting

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    The proposed research question is important as delay in diagnosis and treatment leads to increased severity of the disease and mortality. The RNTCP does not have defined guidelines in adults and children on how quickly the diagnostic workup should be returned to clinicians and patients. Thus this study will help to focus RNTCP efforts on the barriers leading to treatment initiation delays. For clinical practice, this study will help to determine the magnitude of the problem whether- it is patient delay or health service delay, as the interventions to correct modifiable risk factors are different depending on where the delay arises.

  • Barriers to Treatment Initiation in Childhood Tuberculosis in a high incidence setting

    Project Title

    Barriers to early treatment initiation in childhood tuberculosis in high incidence setting

    PI

    Dr. Chhaya Valvi / chhayavalvi@gmail.com

    Co-Investigators Faculty

    Dr. Ajay Chandanwale, Dr. Sandhya Khadse, Dr. Rajesh Kulkarni, Dr. Aarti Kinikar, Dr. Rahul Lokhande, Dr. Dileep Kadam, Dr. Samir  Joshi, Dr. Nikhil Gupte, Dr. Nishi Suryavanshi, Gauri Dhumal, Dr. Bob Bollinger, Andrea Deluca, Dr. Jonathan Golub, Dr. Amita Gupta

    Collaborators

    JHU and the CTU Research Cell

    Study Type

    Cross Sectional Study

    Primary Aims

    • Primary objective: To evaluate the time to treatment initiation in childhood tuberculosis.
    • Secondary objective: To study the barriers in patient delay and health service delay.

    Sample Size

    85

    Duration

    2016 - 2017

    Contact

    chhayavalvi@gmail.com

  • BJGMC JHU Fogarty TB HIV Fogarty Training Program

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    The international Fogarty program has been successful at developing national and international experts through training opportunities. This new Fogarty program will focus on the institutional development of BJGMC to do high-quality TB research.

  • BJGMC JHU Fogarty TB HIV Fogarty Training Program

    Project

    BJGMC JHU Fogarty HIV TB Fogarty Training Program

    P.I.

    Robert Bollinger, Dileep Kadam

    Collaborators

    CCGHE, BJGMC, JHU Center for TB Research

    Study Type

    Training Program

    Primary Aims
    • To identify, recruit, train, and mentor junior faculty members at BJGMC to conduct research focused on HIV-TB
    • To increase the institutional capacity of BJGMC by supporting a sustainable group of faculty who will collaboratively build their expertise around HIV-TB over the course of the program
    • To ensure program responsibility transfers from JHU to BJGMC by the end of the funding cycle by identifying and further mentoring a select group of trainees that will be accountable for the final phase of the program
    • To evaluate the impact of the program and assess the contribution of it to HIV-TB research capacity at BJGMC
    Sample Size

    ~15 junior medical faculty at BJGMC

    Duration

    2013 - 2018

    Website

    http://bjgmc-tb.org

    Contact Information

    adeluca@jhu.edu

    To ensure long-term success of the program, a sequential, 3-phase training program will combine strategic short-term and long-term training in HIV-TB epidemiology and laboratory research. Distance-learning modules will supplement regular professional development activities at BJGMC, and off-site trainings held at Hopkins will round out the program. In addition, a Training Advisory Committee (TAC) that includes senior faculty from JHU and BJGMC will be responsible for approval of the final trainees for each Phase of the program, annual review of progress, and recommendations for strategic scientific training priorities.

  • C-TRIUMPH

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    As part of a five-site consortium, this cohort study based out of BJGMC and the National Institute for Research in Tuberculosis will follow over 3,000 TB cases, household contacts, and children with TB.

  • C-TRIUMPH

    Project

    Cohort for TB research by the Indo-US medical partnership (C-TRIUMPH)

    P.I.

    Amita Gupta, Soumya Swaminathan, Tilak Dhamgaye

    Collaborators

    CCGHE, BJGMC, National Institute of Research in Tuberculosis, JHU Center for TB ResearchRePORT Consortium

    Study Type

    Multi-center Prospective Observational Study

    Primary Aims
    • To measure the host and microbial factors associated with TB treatment outcomes in Indian adults and children (Active TB cohort)
    • To investigate the host and microbial factors associated with progression from infection to active TB disease in adults and children. (Household Contacts)
    • To explore the host and microbial factors associated with TB transmission.(Household Contacts and Control Cohorts)
    Sample Size

    ~1,200 TB cases, ~3,200 household contacts, ~500 controls

    Duration

    2013-2018

    Contact Information

    agupta25@jhmi.edu

    C-TRIUMPH (cohort for TB Research by the Indo-US Medical Partnership). The CCGHE’s Deputy Director Amita Gupta in collaboration with India’s National Institute of Research in Tuberculosis (NIRT) Director Dr. Soumya Swaminathan, have been awarded a 5-year $2.5 million Indo-US grant (collaboratively funded by the US NIH, India’s Department of Biotechnology (DBT), and Indian Council of Medical Research 2013-2018). The consortium will establish a cohort of TB patients, their household contacts and controls to study host and microbial factors associated with TB transmission, disease progression and treatment outcomes. A multidisciplinary initiative, C-TRIUMPH involves leading socio-behavioral, epidemiology, clinical and basic science researchers at NIRT, Chennai, India; Byramjee Jeejeebhoy Medical College Clinical Trials Unit (BJMC CTU) Pune, India; the Institute of Genomics and Integrative Biology (IGIB), New Delhi, India; the Chest Research Foundation (CRF), Pune, India, the University of Washington (UW), Seattle, WA, USA, the University of California San Francisco (UCSF), San Francisco, CA, USA, and JHU, Baltimore, MD, USA.

  • Diagnosis of Active Tuberculosis in HIV infected and Uninfected Young Children in India

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    Since children acquire HIV/TB from their caregivers, active TB is common among HIV-infected young children in India - a vulnerable population, where lack of early detection / prevention of TB often have fatal consequences. We are testing novel ELISPOT assays for the diagnosis of TB in young children, along with potentially modifiable risk factors.

  • Diagnosis of Active Tuberculosis in HIV infected and Uninfected Young Children in India

    Project

    Diagnosis of active tuberculosis in HIV infected and uninfected young children in India

    P.I.

    Sanjay Jain, Renu Bharadwaj

    Collaborators

    CCGHE, BJGMC, NARI, Imperial College of London, JHU Center for TB Research

    Study Type

    Prospective observational cohort study

    Primary Aims

    To assess TB diagnostics in young children

    Sample Size

    350 children under five

    Duration

    2010-2013

    Contact Information

    sjain5@jhmi.edu

    Tuberculosis (TB) is the most common cause of morbidity/mortality in HIV-infected individuals in India, which has among the world's highest burden of HIV and TB. Since children acquire HIV/TB from their caregivers, active TB is highly prevalent (14-67.5%) among HIV-infected young children in India - a vulnerable population, where lack of early detection / prevention of TB often have fatal consequences. Diagnosis of TB is particularly challenging in young children. Due to a similar clinical presentation, active TB cannot be reliably distinguished from HIV (or co-infections). Tuberculin skin test (TST) is often unreliable and bacterial confirmation (culture), when available, is difficult and does not provide a diagnosis for weeks to months.  IFN-gamma-release assays (IGRA) measure T-cells in response to two antigens, ESAT-6 and CFP-10, which are strong targets of T-helper cells, and are encoded by Mycobacterium tuberculosis but not by BCG or most nontuberculous mycobacteria (NTB). IGRAs such as ELISpot are significantly more sensitive/specific than TST for the diagnosis of active TB in young children with high rates of HIV, malnutrition, BCG vaccination and NTB. They are also especially useful for diagnosing extra-pulmonary TB, which is prevalent in young children but often difficult to diagnose, particularly because specimen collection and yield is limited. In collaboration with BJMC, NARI and the Imperial College of London, we are testing novel ELISPOT assays for the diagnosis of TB in young children.  We are also assessing potentially modifiable risk factors (e.g. Vitamin D and indoor air pollution exposure) along with TB in young children.  Results of the study can be found here:

    http://www.ncbi.nlm.nih.gov/pubmed/24386640

    http://www.ncbi.nlm.nih.gov/pubmed/24429313

  • Hair Concentrations of Anti-Tuberculosis Drugs among HIV-Infected and Uninfected Children in India

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    Measurement of adherence to and levels of anti-TB drugs are difficult to measure among children. We are evaluating an innovative therapeutic drug monitoring (TDM) tool by measuring drug concentration in hair samples that estimates an average level of drug exposure over weeks to months.

  • Hair Concentrations of Anti-Tuberculosis Drugs among HIV-Infected and Uninfected Children in India

    Project

    Hair Concentrations of Anti-Tuberculosis Drugs among HIV-Infected and Uninfected Children in India

    P.I.

    Vidya Mave, Anju Kagal, Aarti Kinikar

    Collaborators

    CCGHE, JHU Center for TB Research, JHU Pharmacology, UCSF, BJGMC, IRT

    Study Type

    Prospective observational study

    Primary Aims

    To assess a novel assay to measure TB drug levels in hair

    Sample Size

    50 children

    Duration

    2013-2014

    Website

    http://hopkinscfar.org/funding-opportunities/faculty-development-awards/awards.detail/vidya-mave-md-mph

    Contact Information

    vidyamave@gmail.com

    Tuberculosis is a major cause of mortality among HIV-infected children living in the developing world. Measurement of adherence and drug levels are difficult among children, and thus we propose an innovative therapeutic drug monitoring (TDM) tool by measuring drug concentration in hair samples that estimates an average level of drug exposure over weeks to months. Since hair samples are easy and painless to collect, and can be stored and shipped at room temperature without biohazardous constraints, demonstrating the utility of this form of TDM in pediatric TB would advance the field. We hypothesize that drug concentrations INH and PZA in hair will correlate with reported adherence and plasma drug level assays in children on ATT and will be an acceptable method for TDM in India to evaluate adherence. Therefore, we are proposing to conduct a study to validate hair assay for INH and PZA and to assess the acceptability and utility of hair specimen assays for TDM and as an adherence measure among HIV-infected or uninfected children ≤ 5 years of age diagnosed with TB in India.

  • Indoor Air Pollution and TB Study

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    Assessing the association of indoor air pollution with tuberculosis in India.

  • Indoor Air Pollution and TB Study

    Project

    Indoor Air Pollution and TB Study

    P.I.

    Jonathan Golub, Aarti Kinikar, Sandhya Khadse

    Collaborators

    CCGHE, JHU Center for TB Research, BJGMC, JHSPH

    Study Type

    Prospective observational study

    Primary Aims

    To assess indoor air pollution in homes of persons with and without TB

    Duration

    2013-2014

    Contact Information

    jgolub@jhmi.edu

    Addressing social and environmental risk factors contributing to TB disease is becoming increasingly important for national TB programs. Indoor air pollution (IAP) from the use of biomass fuels and secondhand tobacco smoke (SHS), known risk factors for other respiratory diseases, have recently been postulated to significantly increase risk for TB, as well. Approximately 70% of households in India use biomass as their primary cooking fuel, and India is home to the second largest number of smokers in the world. The purpose of this study is to assess the independent association of TB and exposure to IAP from the use of biomass fuels and from exposure to SHS. Exposure to tobacco, solid fuel smoke, and kerosene is being assessed in homes of children and adults with TB using oral questionnaires as well as hair nicotine biological marker and ambient air environmental markers of carbon monoxide, PM2.5, and nicotine. The results of this study will also lend insight to TB control programs regarding high-risk populations and potential indicators to be used in targeted case-finding strategies, especially in India.

  • Latent TB Screening in Pregnant Women in India

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    Pregnant women may be at special risk of reactivation of TB and progression to active disease. This study is evaluating the standard method for TB screening (the Tuberculin Skin Test, or TST) with a newer diagnostic tool that uses blood to look for infection with TB bacilli.

  • Latent TB Screening in Pregnant Women in India

    Project

    Latent TB screening in pregnant women in India

    P.I.

    Amita Gupta, Jyoti Mathad, Ramesh Bhosale

    Collaborators

    CCGHE, Cornell, BJGMC

    Study Type

    Observational Cohort Study

    Primary Aims

    • To evaluate different methods for latent TB screening among pregnant women

    Sample Size

    450 HIV negative and 200 HIV positive pregnant women

    Contact Information

    agupta25@jhmi.edu

    Tuberculosis (TB) disease is a major cause of mortality in Indian women of reproductive age —approximately 20-50% of women in India are latently infected with Mycobacterium tuberculosis (MTB). Due to immune changes of pregnancy, women are particularly at risk of reactivation and progression to active TB disease during the peripartum period. HIV/TB co-infection during pregnancy contributes to increased morbidity and mortality of both the mother and the neonate. Indian women are not routinely tested for latent tuberculosis infection (LTBI) during pregnancy out of concern that the tuberculin skin test (TST) returns too many false positives, and over-treatment of latent TB infection might spur the emergence of drug-resistant strains.  In 2007, the US Food and Drug Administration approved the use of an interferon gamma releasing assay (IGRA), named QuantiFERON® TB Gold Test in tube (QGIT), for the detection of LTBI. Studies have demonstrated a higher specificity of the QuantiFERON tests as compared to TST, especially in populations vaccinated with BCG vaccine, however, there are no published data on QGIT performance characteristics in pregnant women.  This study will compare the TST to the QGIT for the diagnosis LTBI in pregnant women with and without HIV.

  • Malnutrition and HIV treatment failure

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    In low resource settings, little is known about the effect of malnutrition on early treatment failure of HIV. Using stored samples and data from ongoing studies, we are evaluating baseline indicators of malnutrition in relation to treatment outcomes, in partnership with seven other research groups.

  • Malnutrition and HIV treatment failure

    Project

    Malnutrition and HIV treatment failure

    P.I.

    Amita Gupta

    Collaborators

    CCGHE, ACTG, 9-country trial, A5175

    Study Type

    Retrospective cohort

    Primary Aims
    • To characterize baseline micronutrient status and assess its relationship to baseline disease stage, demographics and simple-to-measure nutritional indices among treatment-naïve HIV-infected adults initiating HAART
    • To assess whether specific measures of baseline malnutrition are independent predictors of early treatment failure
    • To determine whether malnutrition and treatment failure are associated with microbial translocation, immune activation, and reduced immune restoration. Our study has a high likelihood of success because our international team includes leaders in HIV, immunology, statistics and nutrition research
    Website

    http://clinicaltrials.gov/ct2/show/NCT00084136?term=A5175&rank=2

    Contact Information

    agupta25@jhmi.edu

    Highly active antiretroviral therapy (HAART) has reduced morbidity and mortality in HIV-infected persons worldwide. However, early treatment failure (i.e. WHO stage 3 or 4 illnesses or death during the first 24 months of HAART) is >3-fold higher in resource limited settings (RLS) than in resource-rich settings. Early treatment failure is associated with low CD4 count, low body mass index, and anemia, but these markers are nonspecific and could reflect advanced HIV, co-infections, and/or malnutrition. The relative contribution of malnutrition to early treatment failure in RLS is unknown. Up to 40% of adults in RLS are malnourished due to protein-energy, iron or iron-deficiency anemia, or other micronutrient deficiencies, which are associated with immune dysfunction and increased morbidity and mortality. However, the significance of this malnutrition in HIV-infected persons initiating HAART in RLS is unclear. In addition to immune dysfunction, this malnutrition has been associated with impaired gut integrity, increased microbial translocation and immune activation. Recently, chronic HIV infection has also been associated with a “leaky gut” and systemic immune activation. High levels of immune activation result in impaired immune restoration with HAART and HIV disease progression. Therefore, we hypothesize that baseline malnutrition is predictive of early treatment failure among HIV-infected adults in RLS and that early treatment failure is related to the synergistic deleterious effects of HIV and malnutrition on gut mucosal integrity leading to increased systemic immune activation. To address our hypotheses, we will utilize data and cryopreserved samples collected as part of an ongoing trial conducted by the Adults AIDS Clinical Trial Group (ACTG 5175). This NIH-funded study is evaluating the efficacy of HAART among 1571 HIV-infected adults in 8 RLS countries (South Africa, Zimbabwe, Malawi, Thailand, India, Brazil, Peru, Haiti) and the United States. We propose three specific aims:1) To characterize baseline micronutrient status and assess its relationship to baseline disease stage, demographics and simple-to-measure nutritional indices among treatment-naïve HIV-infected adults initiating HAART; 2) To assess whether specific measures of baseline malnutrition are independent predictors of early treatment failure. 3) To determine whether malnutrition and treatment failure are associated with microbial translocation, immune activation, and reduced immune restoration. Our study has a high likelihood of success because our international team includes leaders in HIV, immunology, statistics and nutrition research.

  • Mother-to-Child-Transmission (MTCT)/Six-Week Extended Dose Nevirapine (SWEN) Study Sub-studies:

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    Pregnant women may be at special risk of reactivation of TB and progression to active disease. This study is evaluating the standard method for TB screening (the Tuberculin Skin Test, or TST) with a newer diagnostic tool that uses blood to look for infection with TB bacilli.

  • Mother-to-Child-Transmission (MTCT)/Six-Week Extended Dose Nevirapine (SWEN) Study Sub-studies:

    Project

    The SWEN Study

    P.I.

    Robert Bollinger

    Collaborators

    GGCHE, BJGMC, NARI, JHU, JHSPH

    Study Type

    Phase III RCT

    Primary Aims

    To assess the efficacy of SWEN given to infants to reduce HIV-associated breastmilk transmission

    Sample Size

    783 HIV+ women

    Duration

    2002-2008

    Contact Information

    rcb@jhmi.edu

    More than 800 HIV-positive mother-infant pair trial data collected from 2002 to 2007 was transferred to a specimen repository and available for secondary data analysis.  The following studies are being conducted using these data: South Asia has a high burden of pneumococcal disease,. Influenza and maternal HIV infection appears to impact levels in women and their infants but the magnitude of this effect has not been well established.  In a Gates funded study, we are using stored umbilical cord blood specimens and existing clinical data to assess the transplacental transfer of pneumococcal, influenza and tetanus  antibodies among HIV-infected mother-infant pairs in India.  We are comparing them to HIV-negative mother-infant pairs in Bangladesh.

    Select publications

    TB
    Our group has previously published studies showing the devastating, negative consequences of TB in postpartum HIV-infected Indian women and their children.  In collaboration with Dr. Deborah Persaud’s laboratory, we are now examining the relationship between soluble CD14, maternal TB and HIV MTCT.

    Predictors of Perinatal HBV Transmission in an HIV/HBV Infected Cohort
    Hepatitis B virus (HBV) coinfection is common; affecting greater than 10% of HIV-infected individuals in resource-limited settings.  Although the impact of HIV disease on HBV coinfection has been studied in non-pregnant adults, little is known about the effects of HIV on HBV during pregnancy, particularly the rates of HBV MTCT in HIV/HBV coinfection and characteristics of transmitted HBV infection.  Investigators from Johns Hopkins, the BJ Medical College (BJMC), and UCLA will perform a retrospective analysis of existing data and serum collected during the JHU/Indo collaborative Mother-to-Child Prevention Study/SWEN study between 2002-2007. Laboratory testing for this study will take place at UCLA. The aim of the study is to examine the incidence of perinatal hepatitis B virus transmission in an HIV/HBV co-infected cohort of pregnant women who participated in the MIT/SWEN study and to examine the predictors of HBV MTCT.

    Vitamin D and Mother-to-Child Transmission (MTCT)
    Vitamin D, an immunomodulatory steroid hormone, has been implicated with numerous health conditions.  We are examining this relationship in pregnant HIV-infected Indian women.

  • Pune India Clinical Trials Unit

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    Based in a 1,300 bed public hospital, this trial site is India’s only NIH-funded site to conduct HIV/TB network studies in children and pregnant women. Research priorities are to prevent mother-to-child transmission of HIV and optimize clinical management of HIV/AIDS. 16 trials are underway or ongoing.

  • Pune India Clinical Trials Unit

    Project

    Byramjee Jeejeebhoy Medical College (BJMC), Pune, India: Baltimore-Washington-India (BWI) Clinical Trials Research Site

    P.I.

    Amita Gupta

    Collaborators

    CCGHE, BJGMC, AIDS Clinical Trials Group (ACTG), International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT)

    Study Type

    Multiple

    Primary Aim

    To conduct HIV/TB/infectious disease trials in adults (including pregnant women) and children in India

    Duration

    2007-2021

    Website
    Contact Information

    agupta25@jhmi.edu

    BJMC is a premier Indian medical school with a 1300-bed public hospital, collaborates with JHU to run a large NIH-funded HIV clinical trials unit. It is one of only 25 international HIV/TB clinical trial sites funded by US NIH and is India’s only NIH-funded site to conduct HIV/TB network studies in children and pregnant women. The Indo-US collaborative research group is currently participating in NIH-sponsored clinical trials that address and contribute to two research priority areas: 1) Prevention of mother-to-child HIV transmission and 2) Optimization of clinical management of HIV/AIDS including optimal treatment regimens for adults and children with HIV as well as prevention and treatment of TB, cryptococcal meningitis, HPV co-infections and other HIV-related conditions. The NIAID HIV/AIDS Clinical Trials networks designed to address these areas are the AIDS Clinical Trials Group (ACTG) and the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT). Sixteen trials are underway or have recently been completed at the BJMC CTU.

  • Risk Factors for Drug Resistant TB

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    With drug resistant TB increasingly cited as a priority for India and other developing countries, this study will utilize the C-TRIUMPH framework to evaluate candidate biomarkers of TB treatment response.

  • Risk Factors for Drug Resistant TB

    Project

    The Burden and Risk Factors for Drug-Resistant Tuberculosis in Pune, India

    P.I.

    Vidya Mave, Tilak Dhamgaye

    Collaborators

    CCGHE, BJGMC

    Contact Information

    vidyamave@gmail.com

    Drug resistant TB (MDR-TB and XDR-TB) is increasing worldwide. However, although 20% of all global TB cases occur in India, current estimates of the burden of MDR-TB in India are limited. A well-characterized TB clinical cohort, household cohort and control cohort would provide important epidemiological, clinical and basic science data focused on risk of development of active TB, TB diagnosis, response to treatment, and outcome of drug-susceptible and MDR-TB.  We are conducting a pilot study to establish 3 cohorts: an active Tb cohort (Cohort 1), a household contact (Cohort 2) and a household control cohort (Cohort 3) that will provide clinical and epidemiological data and will serve as a framework for the collection and storage of sputum, serum, urine, peripheral blood mononuclear cells (PBMCs), host mRNA and DNA, and other biological specimens for biobanking in a central repository to be used in laboratory studies to evaluate candidate biomarkers of TB treatment response.

  • TB-Diabetes Cohort

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    This Indo-US collaboration is conducting a study to identify treatment outcomes of Indian patients with both TB and diabetes mellitus.

  • TB-Diabetes Cohort

    Project

    TB Diabetes cohort

    P.I.

    Jonathan Golub, Tilak Dhamgaye

    Collaborators

    CCGHE, JHU Center for TB Research, BJGMC

    Study Type

    Cohort

    Primary Aims
    Sample Size
    Duration

    2013 - 2018

    Website

    http://main.ccghe.net/content/emocha

    Contact Information

    jgolub@jhmi.edu

    The CCGHE in collaboration with the JHU Center for TB Research and BJMC have been awarded a $2.5 million dollar NIH grant (2013-2018) to conduct a study to identify treatment outcomes of Indian patients with both diabetes mellitus and active TB. This study will first look at how many patients who present with active TB have impaired glucose or frank diabetes. It will then compare TB and Diabetes treatment outcomes between patients with both TB and diabetes compared to patients with TB alone.

  • Tuberculosis (TB) in Health Care Workers (HCW)

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    The BJGMC-JHU Fogarty program has identified tuberculosis (TB) in health care workers (HCW) as the program’s most significant priority. Between June 2011 and December 2013, a total of 47 TB cases were identified among HCW at Sassoon General Hospital, a 1,300-bed tertiary care center attached to the medical college. Three of the 47 cases were diagnosed with MDR-TB; two of the 47 health care workers died of TB. Therefore, we propose to study TB infection and disease amongst a cohort of approximately 1,000 HCW over five years, through annual screening using the tuberculin skin test (TST) and Quantiferon (QFT). We will collect data that will allow us to investigate risk factors for active TB disease, risk-factors for transmission to household contacts, and cost-effectiveness parameters should the program be found to be beneficial. Sputum, blood and urine samples will be collected and stored for microbiologic studies of TB acquisition and transmission in the health care setting. We will also obtain blood and urine samples from all participants at every visit for bio-banking and future testing.

  • Tuberculosis (TB) in Health Care Workers (HCW)

    Project Title

    Identifying Strategies to Optimize Prevention, Diagnosis and Care of Tuberculosis in Health Care Workers of Byramjee Jeejeebhoy Government Medical College and Sassoon General Hospital, Pune, India

    P.I.

    Dr. Ajay Chandanwale, Dean of BJ Medical College

    Collaborators

    JHU and the CTU Research Cell

    Study Type

    Prospective Cohort

    Primary Aims

    Primary Objectives:
    1. To evaluate the prevalence of TB infection and disease among HCW’s at BJGMC, Pune and the HHC of HCW’s with active TB.
    2. To study transmission dynamics for TB among HCW and the HHC of active TB affected HCW’s.
    3. To establish a HCW cohort and specimen repository to support novel studies comparing biomarkers of inflammation and immunity between those who do and those who do not develop TB infection and/or active TB disease.
    4. To support novel studies of the treatment and pathogenesis of TB in India among the HCW’s. 

    Secondary Objectives:
    1. To estimate the risk of TB infection for different categories of health care workers
    2. To evaluate the change in host proteomic bio signatures and cytokine/ chemokine levels, using a multiplexed aptamer array-based platform, in serial blood samples, and compare differences between HCW with active disease  who experience TB treatment failure or relapse and those who achieve non-relapsing cure after completion of anti-TB treatment.

    Sample Size

    1000 HCW at BJGMC

    Duration

    2016 - 2021

    Contact

    drshelke@rediffmail.com, doc.sampada1@gmail.com