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.

Assessing prevalence and risk of lung morbidities including lung nodules and cancer using non contrast CT among PLHIV in Pune, India

Post Date: 
2022-11-25
   |   
Countries: 
   |   
Clinical Sites: 
Primary objective Determine the prevalence of pulmonary nodules, including lung cancer using NCCT. Determine the risk of pulmonary nodules, including lung cancer using NCCT. Evaluate the association of smoking, immune suppression, ART, and TB with the prevalence and risk of NCCT-diagnosed pulmonary...

Innovative modelling for predicting TB treatment outcomes in global cohorts

Post Date: 
2021-12-19
Our overarching hypothesis is that clinical and laboratory risk factors for the adversity be treatment outcomes of failure, recurrence and mortality are heterogeneous and time-dependent. Precision medicine approaches supported by Machine learning techniques that overcome the limitations of...

Creating a Hope: A Mixed-Method Approach to Identify Most Acceptable Evidence-Based Psycho-Social Intervention to Improve the Retention in Care among Indian Youth Diagnosed with Multi-Drug Resistant TB (MDR-TB)

Post Date: 
2021-11-02
   |   
Countries: 
   |   
Clinical Sites: 
PURPOSE: Adolescents and youths with MDR/RR tuberculosis reported social isolation, stigmatization, depression, and poor self-esteem highlighting the importance of psychosocial support during tuberculosis treatment phase. Addressing the psycho-social need of youths, by identifying youth friendly...

“Bridging the Gaps”: Understanding the Barriers and Facilitators in the Tuberculosis Prevention Care Cascade for Optimizing Isoniazid Preventive Therapy Uptake among Adults Living with HIV in India, a Mixed-Method Approach

Post Date: 
2021-11-02
   |   
Countries: 
   |   
Clinical Sites: 
PURPOSE: The isoniazid preventive therapy policy has achieved limited success in low and middle-income countries. With limited empirical research exploring the barriers to suboptimal IPT uptake, it is important to understand this knowledge gap. Also, limited programmatic strategies exist to address...

Childhood ‘Omics’ and Mycobacterium tuberculosis-derived BiOsignatures (COMBO) for TB diagnosis

Post Date: 
2021-10-18
   |   
Countries: 
   |   
Clinical Sites: 
The overall objective of the project is to identify Mtb- and/or host-derived biosignatures in children that can achieve World Health Organization (WHO) target product profile (TPP) accuracy thresholds for a non-sputum biomarker-based triage or diagnostic test for childhood TB. We hypothesize that...

Epidemiologic Factors Associated with TB Treatment Outcomes Across Report International Consortia

Post Date: 
2021-08-12
   |   
Rationale: RePORT International was designed to enable cross-consortium data analysis. Now that a large number of consortium sites have completed participant enrollment in Common Protocol Cohort A, we can proceed with large-scale analysis of aligned RePORT data. The current study will harmonize and...

A Nanopore Biosensor for Leveling MTB Antigens in Blood

Post Date: 
2021-04-01
   |   
Countries: 
   |   
Clinical Sites: 
Purpose of the study: The inability to obtain diagnostically useful sputum specimens, or the inability to analyze non-sputum specimens, is a significant contributor to poor diagnostic sensitivity of current TB assays, leading to the WHO to call for the development of non-sputum-based biomarker or...

Effect of Neighborhoods and Peer Networks on substance use and violence among adolescents living with and without HIV in India

Post Date: 
2021-01-28
   |   
Countries: 
   |   
Clinical Sites: 
Purpose of the study: A strong bidirectional association exists between substance use, various forms of violence and HIV. Substance use accounts for 0.8% of the burden of disease measured in disability adjusted life years (DALYs) among adolescents in South Asia. Violence among adolescents living...

Identification of Biomarkers That Can Predict Progression from Latent Tuberculosis Infection to Active Tuberculosis Disease

Post Date: 
2020-08-23
   |   
Countries: 
   |   
Clinical Sites: 
Purpose: The C-TRIUMPH study has identified 20 household contacts (HHC), who have progressed to active TB from its HHCs cohort (Cohort B). Immunological profiling of TB antigen induced biosignatures, profiling of transcriptional and proteomic biosignatures should provide novel insights into the...

Epidemiology and Clinical Outcomes of COVID-19 in India (ECO-19)

Post Date: 
2020-07-09
   |   
Countries: 
   |   
Clinical Sites: 
This study was terminated May 25, 2021 This is a prospective cohort study of adults with suspected COVID-19 to address key knowledge gaps in the epidemiology of disease severity and poor clinical outcomes in India. Results from this study may help clinicians in India focus limited health resources...

Tuberculosis (TB) Aftermath

Post Date: 
2020-06-05
   |   
Countries: 
   |   
Clinical Sites: 
Drs. Vidya Mave and Jonathan Golub are co-PIs and Dr. Barthwal from DY Patil Medical College is local site PI for this study. TB Aftermath seeks to provide evidence for an effective and scalable strategy targeting HHs of treated TB cases, a high priority of the NTEP. Purpose To compare the...

Mental Health Outcomes among Health Care Professionals Involved in the Treatment and Care of COVID 19 Patients in India

Post Date: 
2020-06-01
   |   
Countries: 
   |   
Clinical Sites: 
Drs. Nikhil Gupta and Nishi Suryavanshi are leading this survey project. This study is investigating the immediate impact of the COVID-19 pandemic on mental health outcomes and overall quality of life and what are the factors associated with it among Indian Health care workers. Among health care...

Hybrid Trial for Alcohol Reduction among People with TB and HIV in India

Post Date: 
2020-02-12
   |   
Countries: 
   |   
Clinical Sites: 
Dr. Geetanjali Chander is PI and Dr. Kakrani is local site PI at DY Patil Medical College for this study. The highest incidence of tuberculosis disease (TB) in the world is in India, accounting for 27% of all new cases globally, with approximately 86,000 among persons with HIV (PWH). Unhealthy...

Increasing Market and Public Health Outcomes Through Scaling Up Affordable Access Models of Short Course Preventive Therapy for TB (IMPAACT4TB)

Post Date: 
2019-12-17
   |   
Countries: 
   |   
Clinical Sites: 
Primary Objective: This study is being conducted in Brazil, Cambodia, China, Ethiopia, Ghana, Haiti, India, Indonesia, Kenya, Malawi, Mozambique, South Africa, Tanzania, and Zimbabwe. The overall goal is to reduce TB incidence among (1) people living with HIV who are on antiretroviral therapy, and...

Markers of Lung Impairment in HIV-TB Coinfected Indian Adults

Post Date: 
2019-12-11
   |   
Countries: 
   |   
Clinical Sites: 
Objectives/Aims We will compare the degree of lung impairment between HIV-TB co-infected adults (HIV-TB group) and TB cases without HIV co-infection (TB group) who successfully complete TB therapy. We hypothesize that the HIV-TB group will have a greater degree of lung...

T Cell Biomarkers and T-regulatory Responses to Pediatric TB

Post Date: 
2019-11-21
   |   
Countries: 
   |   
Clinical Sites: 
The goals of this study are to: Validate host T cell biomarkers for diagnosis of pediatric TB Investigate the phenotype and functions of T-regulatory cells in pediatric TB We will use cryopreserved PBMC samples from CTRIUMPH cohorts: Pediatric unconfirmed TB, confirmed TB, latest Tb, and no TB...

Inflammasome Genetics and Tuberculosis Treatment Outcomes

Post Date: 
2019-11-07
   |   
Countries: 
   |   
Clinical Sites: 
Dr. Amita Gupta is a Co-PI on this study. STUDY DESIGN We will conduct a retrospective case-cohort study nested within the CTRIUMPH and EDOTS cohorts to address our study objectives. This will enable us to measure the association of polymorphisms with multiple clinical outcomes simultaneously and...

Evaluation of a Urinary Biomarker Assay for Diagnosis and Test of Cure for Tuberculosis

Post Date: 
2019-09-09
   |   
Countries: 
   |   
Clinical Sites: 
Dr. Jeff Tornheim is PI of this study. METHODS This study will make use of biorepository samples from the Cohort for TB Research by the Indo-US Medical Partnership (CTRIUMPh). CTRIUMPh, funded by the US NIH and Indian Department of Biotechnology, is an academic collaboration between Johns Hopkins...

Visual Field Loss in HIV-Positive Patients of Non-Infectious HIV Retinopathy

Post Date: 
2019-06-02
   |   
Countries: 
   |   
Clinical Sites: 
New study will assess HIV+ patients and determine the prevalence of visual field loss due to noninfectious HIV retinopathy

Prevalence of Tuberculosis in Severely Malnourished Indian Children

Post Date: 
2018-12-18
   |   
Countries: 
   |   
Clinical Sites: 
This study is funded and conducted under the U.S. National Institutes of Health, Fogarty International Center. PIs are Robert Bollinger, MD, MPH; Dr. Muralidhar Tambe, BJGMC Severely malnourished children are vulnerable population for communicable and non-communicable...

Pages

Impact of undernutrition on tuberculosis treatment outcomes in India: A multicenter prospective cohort analysis by Dr. Pranay Sinha

Post Date: 
2023-04-17
   |   
Countries: 
   |   
Clinical Sites: 
Publication: 
Clinical Infectious Diseases
Abstract Background Undernutrition is the leading risk factor for tuberculosis (TB) globally. Its impact on treatment outcomes is poorly defined. Methods We conducted a prospective cohort analysis of adults with drug-sensitive pulmonary TB at 5 sites from 2015–2019. Using multivariable Poisson...

Sex Differences in TB Clinical Presentation, Drug Exposure, and Treatment Outcomes in India

Post Date: 
2023-04-01
   |   
Countries: 
Publication: 
CHEST
Background: The role of sex differences in clinical presentation, TB drug pharmacokinetic variables, and treatment outcomes is unclear. Research question: What is the effect of sex on TB disease severity, drug exposure, and treatment outcome? Study design and methods: This study was a prospective...

The Kynurenine / Tryptophan Ratio is a Sensitive Biomarker for the Diagnosis of Pediatric Tuberculosis among Indian Children

Post Date: 
2022-12-22
   |   
Countries: 
Publication: 
Frontiers in Immunology
Objectives: Pediatric tuberculosis (TB) remains difficult to diagnose. The plasma kynurenine to tryptophan ratio (K/T ratio) is a potential biomarker for TB diagnosis and treatment response but has not been assessed in children. Methods: We performed a targeted diagnostic accuracy analysis of four...

Virological Failure among People living with HIV Receiving Second-Line Antiretroviral Therapy in Pune, India

Post Date: 
2022-12-17
   |   
Countries: 
   |   
Clinical Sites: 
Publication: 
BMC Infectious Diseases
Background The number of people receiving second-line antiretroviral therapy (ART) has increased as global access to ART has expanded. Data on the burden and factors associated with second-line ART virologic failure (VF) from India remain limited. Methods We conducted cross-sectional viral load (VL...

Impact of pregnancy and HIV on LTBI diagnostics and MTB-induced immune response: a cohort study in Pune, India

Post Date: 
2022-11-01
   |   
Countries: 
Publication: 
International Journal of Infectious Diseases
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...

Whole Genome Sequencing Assessing Impact of Diabetes Mellitus on Tuberculosis Mutations and Type of Recurrence in India

Post Date: 
2022-10-06
   |   
Countries: 
Publication: 
Clinical Infectious Diseases
Dr. Vidya Mave and colleagues concluded considerable intrahost mycobacterium tuberculosis mutation rates were present at recurrence among patients with diabetes mellitus.

Concomitant pulmonary disease is common among patients with extrapulmonary TB

Post Date: 
2022-08-12
   |   
Countries: 
   |   
Clinical Sites: 
Publication: 
International Journal of Tuberculosis and Lung Disease
Dr. Shivakumar and his group discovered that a high proportion of patients classified as EPTB in India have concomitant PTB. Their results support the need for improved symptom and CXR screening, and recommends routine sputum TB microbiology screening of all Indian patients with EPTB.

The association of gestational diabetes with HIV infection and tuberculosis in Indian women

Post Date: 
2022-08-01
   |   
Countries: 
Publication: 
The American Journal of Tropical Medicine and Hygiene
Infection of HIV is associated with an increased diabetes risk, which also increases tuberculosis risk. It is unknown if similar associations exist with gestational diabetes (GDM). We screened pregnant women living with and without HIV for GDM using oral glucose tolerance testing. In a subgroup of...

Comparative immune responses to M. tuberculosis in individuals with latent infection or sterile protection against infection

Post Date: 
2022-07-13
   |   
Countries: 
   |   
Clinical Sites: 
Publication: 
bioRxiv
Summary To identify immunologic targets for tuberculosis vaccines more efficacious than BCG, we investigated the immune responses that differentiate individuals with sterile protection against M. tuberculosis (Mtb) infection (TB-resisters) from those who develop latent tuberculosis infection (LTBI-...

Smokeless tobacco use and oral potentially malignant disorders among people living with HIV (PLHIV) in Pune, India: Implications for oral cancer screening in PLHIV

Post Date: 
2022-07-13
   |   
Countries: 
   |   
Clinical Sites: 
Publication: 
PLOS ONE
Introduction In India, smokeless tobacco (SLT) is a predominant form of tobacco used among people living with HIV (PLHIV). Despite SLT being a risk factor for oral potentially malignant disorders (OPMDs), no prior studies have quantified the association of OPMDs with SLT use among PLHIV. This...

Clinical and Immunological Markers of Pulmonary Impairment among People Living with HIV in India

Post Date: 
2022-05-11
   |   
Countries: 
   |   
Clinical Sites: 
Publication: 
Open Forum Infectious Diseases
Background Despite antiretroviral therapy, chronic lung diseases remain an important source of morbidity and mortality in people with HIV (PWH). We sought to identify clinical and immunological markers of pulmonary impairment among PWH in India. Methods Two hundred ten adult PWH receiving...

Performance of Xpert MTB/RIF and Xpert Ultra for the diagnosis of tuberculous meningitis among Indian children

Post Date: 
2022-04-01
   |   
Countries: 
Publication: 
International Journal of Tuberulosis and Lung Disease
OBJECTIVE: To assess Xpert® MTB/RIF (Xpert) and Xpert® MTB/RIF Ultra (Ultra) performance in diagnosing pediatric tuberculous meningitis (TBM). METHODS: We conducted a study among children with suspected meningoencephalitis in Pune, India. Clinical, radiological, laboratory, and treatment data were...

Cycloserine did not increase depression incidence or severity at standard dosing for MDR-TB

Post Date: 
2022-03-24
   |   
Countries: 
Publication: 
European Respitory Journal
In 2018 cycloserine was elevated to World Health Organization (WHO) group B status for multidrug-resistant tuberculosis (MDR-TB), and is recommended in longer MDR-TB treatment regimens [ 1 ]. Inclusion of cycloserine is associated with improved MDR-TB treatment success and reduced mortality, but is...

Burden of COVID-19 and Case Fatality Rate in Pune India: An Analysis of First and Second Wave of the Pandemic

Post Date: 
2022-01-22
   |   
Countries: 
   |   
Clinical Sites: 
Publication: 
IJID Regions
Objective To assess trends in case incidence and fatality rate between the first and second waves, we analyzed programmatic COVID-19 data from Pune city, an epicenter of COVID-19 cases in India. Method The trends of cases incidence, time-to-death and case fatality rate (CFR) were analyzed. Poisson...

Host lipidome and tuberculosis treatment failure

Post Date: 
2022-01-06
   |   
Countries: 
Publication: 
European Respiratory Journal
Introduction: Host lipids play important roles in tuberculosis (TB) pathogenesis. Whether host lipids at TB treatment initiation (baseline) affect subsequent treatment outcomes has not been well characterised. We used unbiased lipidomics to study the prospective association of host lipids with TB...

Increased Moxifloxacin Dosing among MDR-TB Patients with Low-Level Resistance to Moxifloxacin did not Improve Treatment Outcomes in a Tertiary Care Center in Mumbai, India

Post Date: 
2021-12-23
   |   
Countries: 
Publication: 
Open Forum Infectious Diseases
Background Mycobacterium tuberculosis (Mtb) strains resistant to isoniazid and rifampin (multidrug-resistant tuberculosis [MDR-TB]) are increasingly reported worldwide, requiring renewed focus on the nuances of drug resistance. Patients with low-level moxifloxacin resistance may benefit from higher...

Baseline IL-6 is a biomarker for unfavorable tuberculosis treatment outcomes: a multi-site discovery and validation study

Post Date: 
2021-11-08
Publication: 
The European Respiratory Journal
Dr. Akshay Gupte and colleagues discovered that elevated IL-6 can predict poor treatment outcomes, showcasing a need for including IL-6 in clinical screenings.

Immunologic effects of pregnancy on M. tuberculosis: methodology of an observational cohoStages of pregnancy and HIV affect diagnosis of tuberculosis infection and Mycobacterium tuberculosis (MTB)-induced immune response: Findings from PRACHITi, a cohort

Post Date: 
2021-09-21
Publication: 
International Journal of Infectious Diseases
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...

Modern lineages of Mycobacterium tuberculosis were recently introduced in western India and demonstrate increased transmissibility

Post Date: 
2021-08-21
   |   
Countries: 
Publication: 
Open Forum Infectious Diseases
Background Mycobacterium tuberculosis (Mtb) transmissibility may vary between lineages (or variants) and this may contribute to the slow decline of tuberculosis (TB) incidence. The objective of our study was to compare transmissibility across four major lineages (L1-4) of Mtb among participants...

Utility of the interferon-gamma release assay for latent tuberculosis infection screening among indian health-care workers

Post Date: 
2021-07-13
   |   
Countries: 
Publication: 
Indian Journal of Community Medicine
Background: The utility of interferon-gamma release assays (IGRAs) for latent tuberculosis infection (LTBI) screening among health-care workers (HCWs) in low- and middle-income countries (LMICs) remains unclear. Methods: This was a prospective cohort study among HCW trainees...

Pages

ACTG Site Spotlight: BJGMC-JHU Clinical Research Site, Pune, India

Post Date: 
2020-05-05
Source: 
ACTG Network Newsletter
ACTG Logo
The BJGMC-JHU Clinical Research site in Pune, India, is highlighted in this article.

Celebration of the Dedicated Participants and Staff of the REPRIEVE Study in Pune, India

Post Date: 
2019-02-18
REPRIEVE Team Members of the BJGMC Clinical Research Site
Staff and nearly 140 participants in the REPRIEVE study gathered for a community event in Pune, India

Uniting for a Healthier India

Post Date: 
2018-02-14
"The Indo-US clinical research & education partnership started with a single NIH grant to study maternal-infant HIV transmission." Now with 76 studies underway, this short film chronicles the history & impact of our work in India.

Advancing Global TB Research through RePORT

Post Date: 
2016-02-29
Regional Prospective Observational Research for Tuberculosis (RePORT) International is a large, international tuberculosis research effort being undertaken by 4 regional consortia: RePORT Brazil, RePORT South Africa, RePORT Indonesia, and RePORT India. While each region collects and maintains...

Now, docs to get TB leave as cases mount

Post Date: 
2016-02-24
Source: 
Pune Mirror
Too many cases of tuberculosis (TB) among medical trainees and resident doctors in the state have prompted the medical education department to sanction medical leaves exclusively for the malady. This is the first time any state has taken such a step in India. Unusual working hours; close...

Tuberculosis test may underreport in pregnant women with HIV

Post Date: 
2016-01-28
Source: 
Infectious Disease Advisor
Pregnancy may confound tuberculosis (TB) tests results in women with HIV, according to research published in the American Thoracic Society's American Journal of Respiratory and Critical Care Medicine .

Tuberculosis scare in HIV positive pregnant women: most widely-used tuberculosis test fails to diagnose illness

Post Date: 
2016-01-28
Source: 
International Business Times
The most commonly-used tuberculosis (TB) test, TST, has failed to detect TB in HIV positive pregnant women. A research published online in the American Thoracic Society's American Journal of Respiratory and Critical Care Medicine has revealed that the TB test failed to accurately diagnose the...