Clinical Research

Clinical Sites:

DY Patil

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

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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...

Prevalence of Risk Factors for Lung Cancer and Facilitators and Barriers for Tobacco Cessation among People Living with HIV

Post Date:

2020-04-01

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India has the world’s third largest HIV epidemic, with 2.1 million people currently living with HIV and an additional 90,000 new infections each year.[29] At the same time, expansion of the HIV response under India’s premier governmental agency - the National AIDS Control Organization (NACO), has...

The Sentinel Research Network of IeDEA: A Prospective Cohort among People Living with HIV

Post Date:

2020-03-12

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This study is nested within the TREAT Asia HIV Observational Database initiative. The global scale up of antiretroviral therapy (ART) has significantly improved the immune recovery and life expectancy of people living with HIV (PLHIV). However, PLHIV on long-term ART now face health challenges...

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

Post Date:

2020-02-12

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DY Patil

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)

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2019-12-17

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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

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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...

Inflammasome Genetics and Tuberculosis Treatment Outcomes

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2019-11-07

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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

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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...

A5300B/I2003B: Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (PHOENIx)

Post Date:

2019-08-19

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Dr. Amita Gupta is Protocol Co-chair for this multinational clinical trial. BACKGROUND The World Health Organization (WHO) estimates that there were 480,000 incident cases of MDR-TB globally in 2015. MDR-TB has been shown to be almost twice as common in TB...

A5300B/I2003B: Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (PHOENIx)

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2019-08-19

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

Post Date:

2019-06-02

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New study will assess HIV+ patients and determine the prevalence of visual field loss due to noninfectious HIV retinopathy

Immune Correlates of LTBI in HIV-exposed Infants

Post Date:

2019-04-29

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About 2 billion people worldwide harbor asymptomatic latent TB infection (LTBI), activation of which results in progression to TB disease. In areas of high tuberculosis (TB) prevalence, infants and young children have a 3-fold higher risk of progression and death from TB at age < 5 years...

P2010: Phase III Study of the Virologic Efficacy and Safety of Dolutegravir-Containing versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and their Infants “VESTED”

Post Date:

2019-02-06

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This study was terminated September 2, 2021 Full Title: P2010: Phase III Study of the Virologic Efficacy and Safety of Dolutegravir-Containing versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and their Infants “...

Prevalence of Tuberculosis in Severely Malnourished Indian Children

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2018-12-18

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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...

Characterization of Genomics and Metabolomics among Individuals Highly-Exposed, but Resistant to MTB Infection

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2018-12-13

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New study launched in India & South Africa to identify functional relationships between genomics & metabolomics, & to characterize fundamental biological systems underlying resistance to Mtb infection.

Host RNA Expression for Diagnosis and Monitoring of Pediatric TB in Africa and India

Post Date:

2018-12-13

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We are leveraging the RePORT platform by including a cohort of Indian children together with South African children in a large validation study to study on changes in gene expression profiles during treatment for TB

Characterization of TB-specific T Cell Responses in Highly-exposed, but Uninfected Health Care Workers in India

Post Date:

2018-10-25

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This study is funded and conducted under the U.S. National Institutes of Health, Fogarty International Center. PIs are Robert Bollinger, MD, MPH; Jyothi Rengarajan, MD, Emory University. Primary Research Question Do health care workers who remain TST...

Vaginal Microbiota in HIV Infected and Uninfected Pregnant Women (Stand Alone)

Post Date:

2018-10-16

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Amita Gupta, MD, MHS, and Shilpa Naik, MD, are PIs for this study; Rupak Shivakoti, PhD, MSPH, is Co-Investigator The makeup of vaginal microbiota is dynamic and may play a role in the birth outcomes of pregnant women. While HIV and pregnancy both uniquely impact vaginal microbiota, the impact of...

Validating a Novel Functional Correlate of Immune Protection of Tuberculosis

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2018-10-03

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This C-TRIUMPH study is a longitudinal assessment of PBMC samples of progressors and non-progressors among adult household contacts of active TB patients. The purpose of the study is to probe the functional diversity of T cell responses to several of the antigens encoded by Mtb simultaneously in...

Drug use stigma, antiretroviral therapy use, and HIV viral suppression in a community-based sample of people with HIV who inject drugs

Post Date:

2022-10-06

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AIDS

Drug use stigma may be a barrier to HIV viral suppression among people with HIV who inject drugs, thereby hindering efforts to achieve HIV control.

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

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2022-10-06

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Clinical Infectious Diseases

Dr. Vidya Mave and colleagues concluded considerable intrahost mycobacterium tuberculosis mutation rates were present at recurrence among patients with diabetes mellitus.

Clinical and Immunological Markers of Pulmonary Impairment Among People With HIV in India

Post Date:

2022-10-06

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Open Form Infectious Diseases

Dr. Akshay Gupte and team found females were 7 times more likely to have restrictive spirometry pattern and 22 times more likely to have preserved ratio impaired spirometry, compared with men.

Changes in HIV care continuum indicators among community-based samples of HIV-infected people who inject drugs and men who have sex with men across 21 cities in India

Post Date:

2022-10-06

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AIDS Care

The findings by Drs. Shruti Mehta, Gregory Lucas and colleagues show population-specific interventions and routine surveillance are need to facilitate HIV elimination.

Geographical Differences in the Self-Reported Functional Impairment of People with HIV and Associations with Cardiometabolic Risk

Post Date:

2022-09-30

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Clinical Infectious Disease

Background We sought to explore multinational differences in functional status by global burden of disease (GBD) regions in the REPRIEVE cohort. Methods REPRIEVE is a prospective, double-blind, randomized, placebo-controlled, multicenter, phase III primary cardiovascular prevention study of...

Population Pharmacokinetic Modeling and Simulation of Rifapentine Allow Concomitant Antiretroviral Therapy with Efavirenz and Non-Weight Based Dosing

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2022-09-20

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Antimicrobial Agents and Chemotherapy

ABSTRACT The Brief Rifapentine–Isoniazid Efficacy for TB Prevention/A5279 trial demonstrated a 1-month daily regimen of rifapentine and isoniazid was noninferior to 9 months of isoniazid alone for preventing TB in persons living with HIV (PLWH). Our objective was to evaluate rifapentine...

Accuracy of Xpert MTB/RIF Ultra for the diagnosis of tuberculosis in adult patients: a retrospective cohort study

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2022-09-01

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International Journal of Infectious Diseases

Abstract Objectives: The value of the "trace" result in Xpert Ultra for diagnosing active tuberculosis (TB) remains unclear. Our study evaluated the diagnostic accuracy of Xpert MTB/RIF Ultra (Xpert Ultra) (Cepheid, Sunnyvale, USA) over Xpert MTB/RIF (Xpert) (Cepheid, Sunnyvale, USA) and...

Accurate Detection of Esophageal Squamous Cell Carcinoma (ESCC) Using Machine Learning with Methylated DNA Biomarkers

Post Date:

2022-08-15

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Science Direct Gastroenterology

Esophageal cancer, with 544,076 deaths in 2020,1 includes esophageal adenocarcinoma and esophageal squamous cell carcinoma (ESCC). ESCC comprises 90% of esophageal cancers globally. The 5-year survival rate remains poor (15%–25% worldwide) because patients usually present with late disease.2...

Concomitant pulmonary disease is common among patients with extrapulmonary TB

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2022-08-12

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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.

Pregnancy in Women with HIV in a Tuberculosis Preventive Therapy Trial

Post Date:

2022-08-01

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South Africa

Publication:

JAIDS

Background: Tuberculosis preventive therapy (TPT) is recommended for people with HIV infection, including during pregnancy. The effect of TPT exposure at conception and during pregnancy is poorly documented. Methods: We report pregnancy outcomes among South African women...

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

Post Date:

2022-08-01

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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...

Development of shortened HIV-related stigma scales for young people living with HIV and young people affected by HIV in India

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2022-07-31

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BMC Health and Quality of Life Outcomes

Background: HIV-related stigma is associated with poor quality of life and poor healthcare-seeking behaviours in young people living with HIV (YPLHIV) and young people affected by HIV (YPAHIV). India has an estimated 120,000 YPLHIV and 4 million YPAHIV, but efforts to measure HIV-related stigma in...

High-Intensity Versus Standard Thromboprophylaxis Among Adults Hospitalized with COVID-19: A Retrospective Cohort Study

Post Date:

2022-07-22

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United States

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Research and Practice in Thrombosis and Haemostasis

Background and Objectives Current clinical guidelines recommend thromboprophylaxis for adults hospitalized with coronavirus disease 2019 (COVID‐19), yet it is unknown whether higher doses of thromboprophylaxis offer benefits beyond standard doses. Methods We studied electronic health records from...

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

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2022-07-13

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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

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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...

Impact of SARS-CoV-2 variants on inpatient clinical outcome

Post Date:

2022-07-11

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United States

Publication:

Clinical Infectious Diseases

Background Prior observation has shown differences in COVID-19 hospitalization risk between SARS-CoV-2 variants, but limited information describes hospitalization outcomes. Methods Inpatients with COVID-19 at 5 hospitals in the eastern United States were included if they had hypoxia, tachypnea,...

Isoniazid adherence improves survival and incident tuberculosis at 96 weeks among adults initiating antiretroviral therapy with advanced HIV in multiple high burden settings

Post Date:

2022-07-03

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Open Forum Infectious Diseases

Background People with human immunodeficiency virus (HIV) and advanced immunosuppression initiating antiretroviral therapy (ART) remain vulnerable to tuberculosis (TB) and early mortality. To improve early survival, isoniazid preventive therapy (IPT) or empiric TB treatment have been evaluated;...

Inflammatory profile associated with insulin resistance in non-overweight versus overweight people living with HIV in Pune, Western India

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2022-07-01

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Diabetes & Metabolic Syndrome: Clinical Research & Reviews

Background: People living with HIV have greater diabetes (T2DM) than the general population despite lower prevalence of overweight/obesity. Both insulin resistance (IR), a T2DM precursor, and HIV are independently associated with chronic inflammation. Inflammation may be a pathophysiological link...

Prevalence of neurotoxicity symptoms among postpartum women on Isoniazid Preventive Therapy and Efavirenz-based treatment for HIV—An exploratory objective of the IMPAACT P1078 randomized trial

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2022-06-21

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BMC Pregnancy and Childbirth

Background This exploratory analysis investigates the prevalence and risk factors of neurocognitive toxicity in postpartum women on HIV treatment in response to a concern of an Isoniazid Preventive Therapy (IPT)/Efavirenz interaction. Trial Design Pregnant women on HIV treatment from countries with...

Diagnostic biomarkers for active tuberculosis: Progress and challenges

Post Date:

2022-06-20

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