Nikhil Gupte, PhD

Pune, India

Role:

Staff

Deputy Director, BJGMC Clinical Research Site

Dr. Gupte is Deputy Director of the BJGMC-JHU Clinical Research Site, a collaborative research partnership associated with the world’s largest HIV therapeutic trials networks, the AIDS Clinical Trials Group (ACTG) and the International Maternal Pediatric and Adolescent AIDS Clinical Trial Network (IMPAACT). He is also the Director of Data Management and Biostatistics for the center.

Dr. Gupte has more than 20 years of experience in public health research in developing countries and is a recognized leader in biostatistics education in India. Based in Pune, India, Dr. Gupte is the lead statistician for the BJGMC-JHU CRS, which conducts Phase I, II and III clinical trials of therapeutic drug interventions for HIV and co-morbid infections, such as tuberculosis and hepatitis, in adults (including pregnant women) and children. An experienced educator, Dr. Gupte has developed and taught biostatistics courses in India, including a number of University courses and NIH-supported training courses, and he currently leads the Biostatistics training for the BJGMC-JHU Fogarty HIV-TB Training Program.

A recipient of the Hopkins Fogarty fellowship, Dr. Gupte received a PhD in biostatistics from the Johns Hopkins Bloomberg School of Public Health.

Studies/Projects
Publications

MDR-TB Free: Monitoring Adverse Effects, Utilizing Resources Optimally, Knowing Resistance Patterns, and Treatment Strategy

Post Date:

2017-03-24

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Hinduja Hospital

This study is also known as MDR-TB MUKT: Monitoring Adverse Effects, Utilizing Resources Optimally, Knowing Resistance Patterns, and Treatment Strategy. Purpose: To establish an observational cohort of MDR-TB cases and household contacts with accompanying biorepository at PD Hinduja National...

Impact of HIV and Diabetes Mellitus on TB Drug Resistance and Recurrence

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2017-03-02

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This study was terminated in January 2021. Tuberculosis (TB) is the leading cause of mortality globally. With increasing burden of HIV and diabetes mellitus (DM), there is a critical need to understand the microbial response and ensuing disease dynamics of TB in the HIV-infected and diabetic host...

TREAT Asia Pediatric HIV Observational Database

Post Date:

2017-02-09

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Studies conducted under the TREAT Asia Network and funded by amfAR. TREAT Asia Pediatric HIV Observational Database (TApHOD) is a collaborative observational cohort study of infants, children, and adolescents living with HIV. TApHOD study participants are...

TREAT Asia Observational Database

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2017-02-09

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Study conducted under the TREAT Asia Network and funded by amfAR. The TREAT Asia Observational Database's primary study objective is to: Examine HIV natural history, including the relationship between access to ART, demographics, and...

Cost-effectiveness of Xpert MTB/RIF for Diagnosing Pulmonary Tuberculosis in HIV-positive Patients

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2016-12-01

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This study was terminated October 8, 2019. This is a prospective cross-sectional study which will be conducted at BJGMC in Pune, India. The aim of this study is to see whether Xpert MTB/RIF is useful for early detection of pulmonary tuberculosis, and therefore cost-effective, as compared with...

Measuring TB Drugs in Hair as a Tool to Monitor Adherence, Exposure and Response in Patients with HIV

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2016-08-16

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Our study will examine whether hair levels of two key first line tuberculosis drugs will be useful markers to identify individuals at highest risk of treatment failure in active tuberculosis. Our study aims to provide a lowcost clinical tool using hair that can be noninvasively...

A Randomized Therapeutic Interventional Comparative Study between Three Different Modalities of Paediatric Antitubercular Treatment

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2016-06-13

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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

Post Date:

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...

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...

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...

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

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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

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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...

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

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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...

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

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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...

Evaluation of Longitudinal Blood Culture Isolates from BJ Medical College in Pune, India, 2003-2013

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2014-06-16

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This study was terminated July 31, 2014. Antibiotic resistance is a serious global problem and is caused by multiple factors which have led to difficulty in the management of life-threatening, multi-drug resistant (MDR) bacterial bloodstream infections. The knowledge of antibiotic resistance...

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

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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...

Optimizing Treatment to Improve TBM Outcomes in Children

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2014-05-01

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This study, known as TBM Kids, is being conducted in India and Malawi. Primary Objectives To characterize the pharmacokinetics (PK) (plasma and cerebrospinal fluid (CSF)) of rifampicin given at model-derived optimal daily doses and...

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Delays and barriers to early treatment initiation for childhood tuberculosis in India

Post Date:

2019-10-01

Publication:

International Journal of Tuberculosis and Lung Disease

BACKGROUND: India accounts for 27% of global childhood tuberculosis (TB) burden. Understanding barriers to early diagnosis and treatment in children may improve care and outcomes. METHODS: A cross-sectional study was performed among 89 children initiated on anti-TB treatment from a public hospital...

Vitamin D status and risk of incident tuberculosis disease: A nested case-control study, systematic review, and individual-participant data meta-analysis

Post Date:

2019-09-11

Publication:

PLoS Medicine

Background: Few studies have evaluated the association between preexisting vitamin D deficiency and incident tuberculosis (TB). We assessed the impact of baseline vitamins D levels on TB disease risk. Methods and findings: We assessed the association between baseline vitamin D and incident TB in a...

Smoking, alcohol use disorder and tuberculosis treatment outcomes: A dual co-morbidity burden that cannot be ignored

Post Date:

2019-07-31

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PLoS One

BACKGROUND: More than 20% of tuberculosis (TB) disease worldwide may be attributable to smoking and alcohol abuse. India is the second largest consumer of tobacco products, a major consumer of alcohol particularly among males, and has the highest burden of TB globally. The impact of...

Infection free "resisters" among household contacts of adult pulmonary tuberculosis

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2019-07-18

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PLoS One

Despite substantial exposure to infectious pulmonary tuberculosis (TB) cases, some household contacts (HHC) never acquire latent TB infection (LTBI). Characterizing these "resisters" can inform who to study immunologically for the development of TB vaccines. We enrolled HHCs of culture-confirmed...

High risk for latent tuberculosis infection among medical residents and nursing students in India

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2019-07-08

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PLoS One

PLoS ONE: Self-reported TB exposure is underreported, and uptake of LTBI prevention therapy remains low

Age-specific prevalence of TB infection among household contacts of pulmonary tuberculosis: Is it time for TB preventive therapy?

Post Date:

2019-06-21

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Transactions of the Royal Society of Tropical Medicine and Hygiene

BACKGROUND: Household contacts (HHCs) of TB patients are at high risk of developing evidence of latent TB infection (LTBI) and active disease from the index patient. We estimated the age-specific prevalence of LTBI and the force of infection (FI), as a measure of recent transmission, among HHCs of...

Assessment of lung function in successfully treated tuberculosis reveals high burden of ventilatory defects and COPD

Post Date:

2019-05-23

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PLoS One

New in PLoS One: We found a high burden of lung function defects and COPD in tuberculosis cases who successfully completed treatment, suggesting a need for lung function screening as part of patient management.

Subtherapeutic rifampicin concentration is associated with unfavourable tuberculosis treatment outcomes

Post Date:

2019-05-10

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Clinical Infectious Diseases

Rifampicin concentrations were sub-therapeutic in most Indian patients taking a thrice-weekly TB regimen

Respiratory health status is associated with treatment outcomes in pulmonary tuberculosis

Post Date:

2019-04-19

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The International Journal of Tuberculosis and Lung Disease

BACKGROUND: The association between respiratory impairment and tuberculosis (TB) treatment outcomes is not clear. METHODS: We prospectively evaluated respiratory health status, measured using the Saint George's Respiratory Questionnaire (SGRQ), in a cohort of new adult pulmonary TB cases during and...

A population pharmacokinetic analysis shows that arylacetamide deacetylase (AADAC) gene polymorphism and HIV infection affect the exposure of rifapentine

Post Date:

2019-03-29

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Antimicrobial Agents Chemotherapy

New analysis published in Antimicrobial Agents and Chemotherapy!

Willingness to take multidrug-resistant tuberculosis (MDR-TB) preventive therapy among adult and adolescent household contacts of MDR-TB index cases: an international multi-site cross-sectional study

Post Date:

2019-03-28

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Clinical Infectious Diseases

Abstract BACKGROUND: Household contacts (HHCs) of individuals with multidrug-resistant tuberculosis (MDR-TB) are at high risk of infection and subsequent disease. There is limited evidence on the willingness of MDR-TB HHCs to take MDR-TB preventive therapy (TPT) to decrease their risk of TB disease...

Elevated highly sensitive C-reactive protein and d-dimer levels are associated with food insecurity among people living with HIV in Pune, India

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2019-03-04

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Public Health Nutrition

Abstract OBJECTIVE: To assess the prevalence and determinants of food insecurity among people living with HIV (PLWH) in Pune, India and its association with biomarkers known to confer increased risks of morbidity and mortality in this population. DESIGN:...

Barriers to screening and isoniazid preventive therapy for child contacts of tuberculosis patients

Post Date:

2018-10-01

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International Journal of Tuberculosis and Lung Disease

Universal, timely TB screening and IPT for exposed children are urgently needed to reduce pediatric TB in India

Inflammation and micronutrient biomarkers predict clinical HIV treatment failure and incident active TB in HIV-infected adults: a case-control study

Post Date:

2018-09-24

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BMC Medicine

Factors identified through exploratory factor analysis were associated with adverse outcomes in HIV-infected individuals.

The association of household fine particulate matter and kerosene with tuberculosis in women and children in Pune, India

Post Date:

2018-09-07

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Occupational and Environmental Medicine

Use of kerosene cooking fuel is positively associated with TB in women and children in our analysis using reported sources of exposure.

Challenges and opportunities for outreach workers in the Prevention of Mother to Child Transmission of HIV (PMTCT) program in India

Post Date:

2018-09-04

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PLoS One

PLoS One: Prevention of Mother-to-Child Transmission of HIV program in India is one of the largest in the world, and it relies on outreach workers. Our study looked at challenges and opportunities for outreach workers.

The effect of diabetes mellitus on the pharmacokinetics and pharmacodynamics of tuberculosis treatment

Post Date:

2018-08-20

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Antimicrobial Agents and Chemotherapy

DM and higher HbA1c increased the risk of not achieving therapeutic targets for pyrazinamide, but higher pyrazinamide concentrations were asociated with worse microbiologic and clinical outcomes

Tuberculin skin test and QuantiFERON-Gold In Tube assay for diagnosis of latent TB infection among household contacts of pulmonary TB patients in high TB burden setting

Post Date:

2018-08-01

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PLoS One

World Health Organization (WHO) recommends systematic screening of high-risk populations, including household contacts (HHCs) of adult pulmonary tuberculosis (TB) patients, as a key strategy for elimination of TB. QuantiFERON-TB Gold In-Tube (QFT-GIT) assay and tuberculin skin test (TST) are two commonly used tools for the detection of latent tuberculosis infection (LTBI) but may yield differential results, affecting eligibility for TB preventive therapy.

Trends in HbA1c levels and implications for diabetes screening in tuberculosis cases undergoing treatment in India

Post Date:

2018-07-01

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Publication:

International Journal of Tuberculosis and Lung Disease

SETTING: The optimal timing of screening for diabetes mellitus (DM) among tuberculosis (TB) cases is unclear due to the possibility of stress hyperglycemia. DESIGN: We evaluated adult (18 years) pulmonary TB cases at treatment initiation as well as at 3 months,...

Loss to follow‐up and mortality among HIV‐infected adolescents receiving antiretroviral therapy in Pune, India

Post Date:

2018-06-25

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HIV Medicine

Over 6 years, one-third of HIV+ adolescents in this study discontinued medical treatment, indicating a critical need for retention counselling and closer clinical monitoring.

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