Clinical Research

Clinical Sites:

This study was terminated July 6, 2019. It was funded by the Fogarty International Center at the U.S. National Institutes of Health. This study evaluated three different TB treatment regimens in children attending Sassoon General Hospital in Pune, India. A...

Optimal Algorithmic Diagnosis of Genital TB among HIV-infected and Uninfected Infertile Women

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2016-05-26

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This study was terminated March 2020. It was funded by the Fogarty International Center at the U.S. National Institutes of Health. There is a lack of a set protocol universally for diagnosis of genital TB, and for Indian hospitals, India's Revised National...

Whole Genome Sequencing and Trek Sensititre Testing of Stored Isolates of Drug-resistant Tuberculosis from a Clinical Cohort at Hinduja Hospital, Mumbai

Post Date:

2016-05-02

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Hinduja Hospital

Among HIV-positive TB patients presenting to Médecins San Frontières (MSF) clinics in Mumbai, 78% carried MDR-TB strains, with nearly half also found to have additional drug resistance. A previously published cohort of 202 patients cared for at these MSF clinics have enrolled in a...

Barriers to Early Treatment Initiation in Childhood Tuberculosis in High Incidence Setting

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2016-04-21

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This study was terminated October 25, 2019. Funded by the Fogarty International Center and led by PI Dr. Chhaya Tukaram Valvi, the aim of this study is to evaluate the time to treatment initiation and barriers to early treatment initiation in childhood tuberculosis. TB...

Barriers to Implementation of Isoniazid Preventive Treatment (IPT) in Pediatric Contacts of Sputum Positive Adults with Tuberculosis

Post Date:

2016-03-24

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This study was terminated January 3, 2019. It was funded by the Fogarty International Center at the U.S. National Institutes of Health. Young children infected with M.tuberculosis can rapidly progress to pulmonary and extrapulmonary disease with high rates of mortality and...

The Human Virome in Health and Disease

Post Date:

2016-02-21

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This study was terminated in September 2020. This study is part of the Antimicrobial Resistance study referenced below, Some samples were used from the Cohort for Tuberculosis Research by the Indo-US Medical Partnership (C-TRIUMPH), under the Regional...

Whole Genome Sequencing of Clinical Isolates from Patients with Multidrug Resistant Tuberculosis in India

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2015-11-12

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This study was terminated August 9, 2019. Comparative genomic analysis using whole genome sequencing (WGS) offers an opportunity to understand the specific mutations associated with drug resistance and the phenotypic behavior of TB. As treatment programs incorporate more...

Residual Respiratory Impairment Following Pulmonary Tuberculosis

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2015-09-13

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This study is conducted by the Cohort for Tuberculosis Research by the Indo-US Medical Partnership (C-TRIUMPH) under the Regional Prospective Observational Research for Tuberculosis (RePORT) Network, an international TB consortium. Many TB patients have...

A5300/IMPAACT2003: Study of MDR TB Cases and Their Household Contacts: Operational Feasibility to Inform PHOENIx Trial Design

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2015-09-01

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This clinical trial was terminated July 18, 2017. It was a study conducted under both the AIDS Clinical Trial Group (ACTG) and the the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network, and funded by the U.S. National Institutes of Health. Dr...

Prevalence Survey of Risk Factors for Tuberculosis and Non-communicable Diseases in an HIV-positive Population in Pune, India

Post Date:

2015-08-17

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This study is conducted under the TREAT Asia Network and funded by amfAR. The primary objective of this study is to assess the prevalence of risk factors for tuberculosis and non-communicable diseases (NCDs)--coronary artery disease and diabetes mellitus--...

A5290: A Randomized, Phase 2b Study of a Double-Dose Lopinavir/Ritonavir-Based Antiretroviral Regimen with Rifampin-Based Tuberculosis Treatment versus a Standard-Dose Lopinavir/Ritonavir-Based Antiretroviral Regimen with Rifabutin-Based Tuberculosis...

Post Date:

2015-07-07

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This study was terminated February 23, 2016; it was conducted under the AIDS Clinical Trials Group (ACTG) and funded by the U.S. National Institutes of Health.. Full Title: A5290, A Randomized, Phase 2b Study of a Double-Dose Lopinavir/Ritonavir-Based Antiretroviral Regimen...

Bacterial Antimicrobial Resistance Patterns in Pune, India: Substudy on Community Health-Seeking Behavior Among Patients Admitted with Acute Febrile Illness

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2015-05-28

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Objectives: To describe the patterns of health-care seeking behavior and prior outpatient care among patients admitted with acute febrile illness to Sassoon Hospital To determine the effects of outpatient behaviors and prior treatments on the antimicrobial...

Barriers for Intervention to Prevent Occupationally Acquired Tuberculosis in Healthcare Workers

Post Date:

2015-05-21

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This study was terminated April 20, 2017; it was funded by the Fogarty International Center at the U.S. National Institutes of Health. Observational study to assess the current status of implementation of interventions for preventing occupationally acquired...

Risk of Tuberculosis among Health Care Workers and Trainees in a Tertiary-care Hospital in Pune, India

Post Date:

2015-04-15

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This study was terminated April 24, 2018. It was funded by the Fogarty International Center at the U.S. National Institutes of Health. A retrospective study of health care workers (HCWs) was conducted by investigators of the Byramjee Jeejeebhoy Medical and...

Predictive Value of TB-symptom Screen in HIV-infected and HIV-uninfected Pregnant Women in Pune, India

Post Date:

2014-10-28

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This study was terminated July 17, 2017. This is a cross sectional observational study will be conducted at BJGMC to establish what the predictive value of the WHO TB symptom screen is in pregnant women in India. We hypothesize that the WHO TB symptom...

Inflammation in HIV-infected Pregnant Women: Relationship with Diet, Gut Microbiome and Preterm Birth

Post Date:

2014-10-28

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This study was terminated May 7, 2018. P regnancy is a state of relative immunosuppression in order to protect the fetus from being rejected. It has also been shown that the Th-1 helper cell response, which is normally necessary for overcoming TB infection...

Impact of Immune Changes of HIV and Stages of Pregnancy on Tuberculosis

Post Date:

2014-09-01

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This is the Parent Study for CCGHE’s PRACHITI (PRegnancy And CHanges In TuberculosIs) effort. It's supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development at the U.S. National Institutes of Health. Purpose: TB is a...

Diagnosis of Tuberculosis Infection and Th1 Immune Response in Pregnant Women in India

Post Date:

2014-09-01

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This study was terminated April 16, 2018. Tuberculosis (TB) disease is a major cause of mortality among Indian women of reproductive age; approximately 20-50% of women in India are latently infected with Mycobacterium tuberculosis (MTB). Due to immune...

A5279: Phase III Clinical Trial of Ultra-Short-Course Rifapentine/Isoniazid for the Prevention of Active Tuberculosis in HIV-infected Individuals with Latent Tuberculosis Infection

Post Date:

2014-06-30

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This study ended April 27, 2015; it was conducted under the AIDS Clinical Trials Group (ACTG) and funded by the U.S. National Institutes of Health. Dr. Amita Gupta was Protocol Co-Vice Chair for this multinational clinical trial being conducted in Botswana, Brazil, Haiti,...

ART Study 1: Database: Epidemiology of HIV/AIDS and Associated Comorbidities in a Public Antiretroviral Treatment (ART) Clinic at BJGMC in Pune

Post Date:

2014-06-14

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Hinduja Hospital

Since 2004, the National AIDS Control Program of India has been rolling out free antiretroviral therapy. Byramjee Jeejeebhoy Government Medical College (BJGMC), located in Pune, India, is now the largest HIV clinic in India, with over 26,000 adult and pediatric patients registered since 2005...

Systemic Inflammation in Pregnant Women With Latent Tuberculosis Infection

Post Date:

2021-01-27

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Frontiers in Immunology

Background: Recent studies in adults have characterized differences in systemic inflammation between adults with and without latent tuberculosis infection (LTBI+ vs. LTBI-). Potential differences in systemic inflammation by LTBI status has not been assess in pregnant women. Methods: We conducted a...

Higher interleukin-6 levels and changes in transforming growth factor-β are associated with lung impairment in pulmonary tuberculosis

Post Date:

2021-01-18

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ERJ Open Resource

Higher levels of IL-6 and slow-to-resolve TGF-β are associated with lung impairment in treated tuberculosis. These results have important implications for clinical trials of immunomodulatory therapies to prevent tuberculosis-associated lung disease. http://openres.ersjournals.com/lookup/doi/...

Detection of genital tuberculosis among women with infertility using best clinical practices in India: An implementation study

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2021-01-15

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Publication:

Indian Journal of Tuberculosis

Background Diagnosis of genital tuberculosis (TB) as a cause of infertility still remains a diagnostic dilemma for clinicians, as no standard guidelines exist. The recently proposed best practices for genital TB diagnosis have not been evaluated yet in India. Objectives To implement best practices...

Association of Maternal Inflammation During Pregnancy: Relationship with Birth Outcomes & Infant Growth Among Women with and without HIV in India

Post Date:

2021-01-12

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JAMA Network Open

Abstract Importance The association of elevated levels of specific inflammatory markers during pregnancy with adverse birth outcomes and infant growth could indicate pathways for potential interventions. Objective To evaluate whether higher levels of certain inflammatory markers during pregnancy...

Stages of pregnancy and HIV affect diagnosis of tuberculosis infection and Mycobacterium Tuberculosis (MTB)-induced immune response: Findings from PRACHITi, a cohort study in Pune, India

Post Date:

2021-01-11

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IJID

Background Accurate tuberculosis infection (TBI) tests are critical for pregnant women, especially those with HIV, who have a high risk of TB disease. Methods We enrolled interferon gamma release assay (IGRA)+ pregnant women with and without HIV in a longitudinal study, followed up at delivery and...

Higher IL-6 Levels and Changes in TGF-β are Associated with Lung Impairment in Pulmonary Tuberculosis

Post Date:

2021-01-08

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ERJ

Pulmonary tuberculosis (PTB) is associated with granuloma formation, necrosis and cavitation in lung tissue. Lung injury in PTB can persist despite microbiological cure and is associated with chronic obstructive pulmonary disease (COPD) independent of smoking exposure[1]. Furthermore, pulmonary...

Validation of NINA-DISH food frequency questionnaire with multiple 24-hour dietary recalls among pregnant women in Pune, India

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2021-01-06

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The British Journal of Nutrition

Adequate dietary intake is critical to prevent adverse pregnancy outcomes. India has a high burden of maternal and child morbidity and mortality, but there is a lack of adequate tools to assess dietary intake. We validate a food frequency questionnaire (FFQ), New-Interactive Nutrition Assistant-...

The clinical course of COVID-19 in the outpatient setting: a prospective cohort study

Post Date:

2021-01-05

Publication:

Open Forum Infectious Diseases

Background Outpatient coronavirus disease 2019 (COVID-19) has been insufficiently characterized. To determine the progression of disease and determinants of hospitalization, we conducted a prospective cohort study. Methods Outpatient adults with positive reverse transcription polymerase chain...

Measuring TB drug levels in the hair in adults and children to monitor drug exposure and outcomes

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2021-01-01

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International Journal of Tuberculosis and Lung Disease

INTRODUCTION: Testing for anti-TB drugs in small hair samples may serve as a non-invasive tool to measure cumulative drug exposure and/or adherence, as these determine treatment success. We aimed to assess how well hair assays of TB drugs predict TB treatment outcomes.METHODS: A small thatch of...

Association of Vegetable and Animal Flesh Intake with Inflammation in Pregnant Women from India

Post Date:

2020-12-08

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MDPI

In pregnant women, studies are lacking on the relationship of vegetable and animal flesh (poultry, red meat and seafood) intake with inflammation...

Nevirapine pharmacokinetics in HIV-infected persons receiving rifapentine and isoniazid for TB prevention

Post Date:

2020-11-26

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United States

Publication:

The Journal of Antimicrobial Chemotherapy

Background: The use of rifamycin antibiotics for TB prevention carries a risk of detrimental drug-drug interactions with concomitantly used ART. Objectives: To evaluate the interaction of the antiretroviral drug nevirapine in combination with 4 weeks of daily rifapentine and isoniazid for TB...

Xpert MTB/RIF Ultra for the Diagnosis of Tuberculous Meningitis: A Small Step Forward

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2020-11-05

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Clinical Infectious Diseases

The delayed diagnosis of tuberculous meningitis (TBM) leads to poor outcomes, yet the current diagnostic methods for identifying Mycobacterium tuberculosis in cerebrospinal fluid (CSF) are inadequate. The first comparative study of the new GeneXpert MTB/RIF Ultra (Xpert Ultra) for TBM diagnosis...

Using a composite maternal-infant outcome measure in tuberculosis prevention studies among pregnant women

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2020-11-04

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Clinical Infectious Diseases

Background: Tuberculosis (TB) preventive therapy (TPT) among pregnant women reduces the risk of TB in mothers and infants, but the timing of initiation should consider potential adverse effects. We propose an analytical approach to evaluate the risk-benefit of interventions. Methods: A novel...

Assessment of persistent depression among TB patients

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2020-11-01

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International Journal of Tuberculosis and Lung Disease

(No abstract available)

The burden of anxiety among people living with HIV during the COVID-19 pandemic in Pune, India

Post Date:

2020-10-23

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BMC Public Health

Introduction: Globally, India has the third largest population of people living with HIV (PLHIV) and the second highest number of COVID-19 cases. Anxiety is associated with antiretroviral therapy (ART) nonadherence. It is crucial to understand the burden of anxiety and its sources among Asian...

The Impact of Hypertension and Use of Calcium Channel Blockers on Tuberculosis Treatment Outcomes

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2020-09-24

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Clinical Infectious Diseases

Background: Hypertension induces systemic inflammation, but its impact on the outcome of infectious diseases like tuberculosis (TB) is unknown. Calcium channel blockers (CCB) improve TB treatment outcomes in pre-clinical models, but their effect in patients with TB remain unclear. Methods: This...

Patient Trajectories Among Persons Hospitalized for COVID-19: A Cohort Study

Post Date:

2020-09-22

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United States

Publication:

Annals of Internals Medicine

Risk factors for progression of coronavirus 2019 (COVID-19) to severe disease or death are underexplored in U.S. cohorts.

Mental health and quality of life among healthcare professionals during the COVID-19 pandemic in India

Post Date:

2020-09-11

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Brain and Behavior

Background: The COVID-19 pandemic has placed healthcare professionals (HCP) in stressful circumstances with increased patient loads and a high risk of exposure. We sought to assess the mental health and quality of life (QoL) of Indian HCPs, the fourth highest-burden country for COVID-19. Method:...

Pharmacokinetics and drug-drug interactions of isoniazid and efavirenz in pregnant women living with HIV in high TB incidence settings: importance of genotyping

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2020-09-09

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Clinical Pharmacology and Therapeutics

World Health Organization guidelines recommend that individuals living with HIV receive ≥6 months of isoniazid preventive therapy, including pregnant women.

The effect of TB treatment on health-related quality of life for people with advanced HIV

Post Date:

2020-09-01

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