Clinical Research

Leadership

Our Indo-JHU Clinical Research Partnership is located in Pune and is directed by Dr. Amita Gupta (Baltimore, MD), with onsite direction from Dr. Vidya Mave, Dr. Nishi Suryavanshi, and Dr. Nikhil Gupte (Pune). The Indo-JHU Partnership employs more than 200 people and in addition to our memberships in consortia with many esteemed Indian research institutions, we have formal agreements with:

Byramjee Jeejeebhoy Government Medical College, and Sassoon General Hospital (BJGMC). Pune, India
DY Patil Medical College, Hospital and Research Center. Pune, India
National Institute for Research in Tuberculosis. Chennai, India
PD Hinduja Hospital and Medical Group. Mumbai, India
Medanta The Medicity. Gurgaon, India
Bharati Vidyapeeth Medical College. Pune, India

Studies/Projects
Publications
News

Optimizing Treatment to Improve TBM Outcomes in Children

Post Date:

2014-05-01

Countries:

India

Clinical Sites:

BJGMC

NIRT

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...

P1078: A Phase IV Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Safety of Immediate (Antepartum-Initiated) Versus Deferred (Postpartum-Initiated) Isoniazid Preventive Therapy Among HIV-Infected Women in High TB Incidence Settings

Post Date:

2014-04-01

Countries:

India

Clinical Sites:

BJGMC

This is a clinical trial conducted under the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network and funded by the U.S. National Institutes of Health. Dr. Amita Gupta is Protocol Chair for this multinational clinical trial being conducted in...

Evaluation of HIV Disease Burden in Hospitalized Patients at Sassoon General Hospital in Pune, India

Post Date:

2013-11-18

Countries:

India

Clinical Sites:

BJGMC

This study was terminated September 13, 2005. The goal of this project was to conduct both a retrospective and prospective epidemiological study of the burden of HIV disease at Sassoon General Hospital. The specific objectives of the study were to establish the proportion of...

Tuberculosis Noon Conference

Post Date:

2013-10-24

Countries:

Clinical Sites:

This effort ended in 2015. As part of the BJGMC-Johns Hopkins India Fogarty Training Program, from 2013-2015 CCGHE hosted the live Tuberculosis Noon Conference webcast. Led by Drs. Maunank Shah, Jonathan Golub, and Richard Chaisson, these webcast meetings brought together Johns Hopkins TB...

Cohort for Tuberculosis Research by the Indo-US Medical Partnership (C-TRIUMPH)

Post Date:

2013-09-28

Countries:

India

Clinical Sites:

BJGMC

NIRT

Collaboratively funded by the US NIH, India’s Department of Biotechnology [DBT], and Indian Council of Medical Research, the Cohort for TB Research by the Indo-US Medical Partnership (C-TRIUMPH) is an Indo-US research consortium that is part of RePORT India, a countrywide consortium for TB...

Assessing the Association of Indoor Air Pollution with Tuberculosis in Adult Women and Children under 5 Years of Age

Post Date:

2013-09-15

Countries:

India

This study is conducted 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. Addressing social and...

Community Home Based India Prevention of Mother to Child Transmission of HIV (COMBIND)

Post Date:

2013-09-02

Countries:

India

Clinical Sites:

BJGMC

This study ended May 14, 2019. CCGHE is assessing whether equipping Community Health Workers with mobile health technology and involving them in technology training and personal empowerment seminars can help prevent mother-to-child...

Impact of Diabetes on TB Treatment Outcomes

Post Date:

2013-02-01

Countries:

India

Clinical Sites:

BJGMC

DY Patil

CCGHE, the JHU Center for TB Research and BJGMC have been awarded a $2.5 million dollar NIH grant (2013-2018) to conduct a study to evaluate treatment outcomes among Indian patients with both diabetes mellitus and active TB. This study is assessing the prevalence of impaired glucose or frank...

Bacterial Antimicrobial Resistance Patterns in Pune, India

Post Date:

2013-01-10

Countries:

India

Clinical Sites:

BJGMC

DY Patil

This study was terminated September 24, 2019. Evaluate etiology of acute fever and bacterial drug resistance patterns among adults and children in India.

ONCOGRID: An mHealth Approach to Prevention and Early Diagnosis of Oral Cancer in Rural South India

Post Date:

2012-11-01

Countries:

India

This study ended February 7, 2017. The Indian sub-continent is burdened with 80% of the world’s patients with oral cancer, and delay in oral cancer diagnosis is one of the major problems that leads to poor treatment outcomes (V. Shanta, R. Swaminathan, R...

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

Post Date:

2012-07-24

Countries:

India

Clinical Sites:

BJGMC

Tuberculosis (TB) is the most common cause of morbidity/mortality in HIV-infected individuals in India. India has the world's highest burden of HIV and TB, and since children acquire HIV/TB from their caregivers, active TB is highly prevalent (14-67.5%) among HIV-infected young children in...

A5288: MULTIOCTAVE, Management Using the Latest Technologies in Resource-limited Settings to Optimize Combination Therapy After Viral Failure

Post Date:

2012-07-16

Countries:

India

This study was terminated in March 2020. It was a mult-country clinical trial conducted in Brazil, Haiti, India, Kenya, Malawi, Peru, South Africa, Thailand, Uganda, and Zambia under the AIDS Clinical Trials Group (ACTG) and funded by the U.S. National Institutes of Health. ...

RePORT India

Post Date:

2012-06-30

Countries:

Clinical Sites:

RePORT India is a joint venture between the Indian and US governments. The Indo-US Vaccine Action Program, a collaboration between the Indian Department of Biotechnology (DBT), the Indian Council of Medical Research (ICMR), and the US NIH, is co-funding six teams of India- and US-based...

C-TRIUMPH Pilot Study: Burden and Risk Factors for Drug-resistant Tuberculosis in Pune, India

Post Date:

2012-05-29

Countries:

India

Clinical Sites:

BJGMC

This pilot study ended in April 2015. Drug resistant TB (MDR-TB and XDR-TB) is increasing worldwide. 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...

Sexually Transmitted Infections among Women in the Reproductive Age Group in Shevgaon, Ahmednagar District, Maharashtra, India

Post Date:

2011-05-15

Countries:

India

This study was conducted in 2011. Sexually transmitted infections (STIs) constitute a significant epidemiological burden all over the world especially in middle and low income countries. Women are more vulnerable to STIs due to several biological and socio-economic reasons. Although transmission of...

A5273: Multicenter Study of Options for Second-Line Effective Combination Therapy (SELECT)

Post Date:

2011-05-12

Countries:

India

Clinical Sites:

BJGMC

This study was terminated May 2, 2017; it was conducted under the AIDS Clinical Trials Group (ACTG) and funded by the U.S. National Institutes of Health. This was a multinational clinical trial conducted in Brazil, India, Kenya, Malawi, Peru, South Africa, Tanzania, Thailand...

Predictors of Perinatal HBV Transmission in an HIV/HBV Infected Cohort

Post Date:

2011-04-22

Countries:

India

This study ended in 2014. Hepatitis B virus (HBV) coinfection is common; affecting greater than 10% of HIV-infected individuals in resource-limited settings(1-3). Although the impact of HIV disease on HBV coinfection has been studied in non-pregnant adults, little is known...

A5282: A Randomized, Phase II Trial to Compare an HPV Test-and-Treat Strategy to a Cytology-Based Strategy for Prevention of CIN 2+ in HIV-Infected Women

Post Date:

2011-03-15

Countries:

India

Indo-JHU partnership work on this trial was officially terminated September 10, 2018; it was conducted under the AIDS Clinical Trials Group (ACTG) and funded by the U.S. National Institutes of Health. This multi-country trial is being conducted in Botswana, Haiti, India,...

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

Post Date:

2011-01-01

Countries:

India

Clinical Sites:

BJGMC

This prospective observational study aimed to evaluate the burden of cryptococcal disease among approximately 200 HIV-infected adults with low CD4 cell counts in Pune, India to determine whether a Cryptococcal screening strategy should be the standard of care among patients with advanced HIV...

P1073: Study of Immune Reconstitution Inflammatory Syndrome (IRIS) for International Sites Initiating Highly Active Antiretroviral Therapy (HAART) in Infants and Children < 72 Months of Age

Post Date:

2010-11-15

Countries:

India

Clinical Sites:

BJGMC

This study was terminated April 23, 2015. This was a multi-national study conducted in India, South Africa, and Tanzania under the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network and funded by the U.S. National Institutes of Health...

An Evaluation of Baseline Kidney Function in the REPRIEVE Trial of Pitavastatin in Human Immunodeficiency Virus

Post Date:

2020-08-01

Publication:

The Journal of Infectious Diseases

Background Chronic kidney disease is a common comorbid condition among persons living with human immunodeficiency virus (PWH). We characterized baseline kidney function in the REPRIEVE (Randomized Trial to Prevent Vascular Events in HIV) trial cohort. Methods REPRIEVE enrolled PWH with low to...

Tuberculosis preventive treatment should be considered for all household contacts of pulmonary tuberculosis patients in India

Post Date:

2020-07-29

Countries:

India

Clinical Sites:

BJGMC

Publication:

PLoS One

PLoS One: Dr. Mandar Paradkar and colleagues conducted a CTRIUMPH study that supports TB preventive therapy for all household contacts of pulmonary TB patients in India

Effects of Pregnancy and Isoniazid Preventive Therapy on M. tuberculosis Interferon Gamma Response Assays in Women with HIV

Post Date:

2020-07-28

Countries:

India

Publication:

Clinical Infectious Diseases

944 women with HIV participating in a randomized, double-blind, placebo-controlled study comparing 28 weeks of IPT antepartum versus postpartum, were tested by QuantiFERON-gold-in-tube (QGIT) antepartum and by QGIT and tuberculin skin test (TST) at delivery and postpartum.

Impact of the Fogarty Training Program on Trainee and Institutional Research Capacity Building at a Government Medical College in India

Post Date:

2020-07-28

Countries:

India

Clinical Sites:

BJGMC

Publication:

Annals of Global Health

Gauri Dumal and colleagues assess the impact of the 5-year HIV-TB research training program on building individual research capacity at BJGMC.

Clinical features associated with linezolid resistance among multidrug resistant tuberculosis patients at a tertiary care hospital in Mumbai, India

Post Date:

2020-07-24

Countries:

India

Publication:

Journal of Clinical Tuberculosis and other Mycobacterial Diseases

Background: Multidrug-resistant tuberculosis (MDR-TB) is an increasing problem worldwide, and 24% occurs in India. Linezolid is associated with improved MDR-TB treatment outcomes but causes significant side-effects and drug susceptibility testing (DST) is rarely available. This study assessed...

Chronic Obstructive Pulmonary Disease Endotypes in Low- and Middle-Income Country Settings: Precision Medicine for All

Post Date:

2020-07-15

Publication:

Am J Respir Crit Care Med

Chronic obstructive pulmonary disease (COPD) is a heterogeneous disease marked by largely irreversible airflow obstruction due to small airway obstruction and emphysema that results from complex gene–environment interactions over the lifespan of an individual. Although the clinical definition of...

Drug resistant TB spine in a two year old child: A case report

Post Date:

2020-07-14

Countries:

India

Publication:

Indian Journal of Tuberculosis

Spinal tuberculosis (TB) is a disease of high morbidity that is associated with deformity and neurological sequelae, especially in growing children. Children diagnosed with spinal TB need to be monitored closely for clinical improvements. Previous history of antituberculous therapy (ATT), poor...

Mullen Scales of Early Learning Adaptation for Assessment of Indian Children and Application to Tuberculous Meningitis

Post Date:

2020-07-04

Countries:

India

Publication:

Journal of Tropical Pediatrics

Introduction: Tuberculous meningitis (TBM) results in significant morbidity and mortality among children worldwide. Associated neurocognitive complications are common but not well characterized. The Mullen Scales of Early Learning (MSEL), a well-established measure for assessment of...

A mobile health-facilitated behavioral intervention for community health workers improves exclusive breastfeeding and early infant HIV diagnosis in India: A cluster randomized trial

Post Date:

2020-07-03

Countries:

India

Clinical Sites:

BJGMC

Publication:

Journal of the International AIDS Society

When community health workers used a mobile health intervention with HIV+ women to deliver care, there was a higher uptake of exclusive breastfeeding at two months and early infant HIV diagnosis at six weeks

Impact of Nationwide and Regional Lockdowns on Incident COVID-19 Cases in Pune City, India

Post Date:

2020-06-16

Countries:

India

Clinical Sites:

BJGMC

Publication:

Scientific Reports

Assessing the impact of lockdowns on COVID-19 incidence may provide important lessons for management of pandemic in resource-limited settings. We examined growth of incident confirmed COVID-19 patients before, during and after lockdowns during the first wave in Pune city that reported the largest...

Once-Weekly Rifapentine and Isoniazid (3HP) Among Patients with HIV Taking Dolutegravir-based Antiretroviral Therapy: A Phase I/II Clinical Trial

Post Date:

2020-06-01

Publication:

The Lancet HIV

Background Short-course preventive therapy with 12 doses of once-weekly rifapentine (900 mg) plus isoniazid (900 mg) could greatly improve tuberculosis control, especially in areas with high co-endemicity with HIV. However, a small previous trial of such therapy with dolutegravir in healthy, HIV-...

High Burden of Bloodstream Infections Associated with Antimicrobial Resistance and Mortality in the Neonatal Intensive Care Unit in Pune, India

Post Date:

2020-05-18

Publication:

Clinical Infectious Diseases

Background: Antimicrobial resistance (AMR) is a growing threat to newborns in low and middle income countries (LMIC). Methods: We performed a prospective cohort study in three tertiary Neonatal Intensive Care Units (NICUs) in Pune, India, to describe the epidemiology of neonatal bloodstream...

Once-weekly Rifapentine and Isoniazid for Tuberculosis Prevention in Patients With HIV Taking Dolutegravir-Based Antiretroviral Therapy: A Phase 1/2 Trial

Post Date:

2020-03-30

Publication:

Lancet HIV

Short-course preventive therapy with 12 doses of once-weekly rifapentine (900 mg) plus isoniazid (900 mg) could greatly improve tuberculosis control, especially in areas with high co-endemicity with HIV.

TB prevention strategies and unanswered questions for pregnant and postpartum women living with HIV: the need for improved evidence

Post Date:

2020-03-23

Publication:

Journal of the International AIDS Society

World TB Day viewpoint on the need for more data about TB treatment for pregnant and postpartum women in J Int AIDS Soc by Drs. Jyoti Mathad and Amita Gupta.

HIV, Pregnancy, and Isoniazid Preventive Therapy. Reply

Post Date:

2020-03-19

Countries:

India

Publication:

The New England Journal of Medicine

Gupta et al. (Oct. 3 issue)1 report a higher incidence of adverse pregnancy outcomes among women with human immunodeficiency virus (HIV) infection who were exposed to isoniazid preventive therapy (IPT) during the second and third trimesters than among those not exposed to IPT during pregnancy. From...

Hepatotoxicity and Liver-Related Mortality in Women of Child-Bearing Potential Living With HIV and High CD4 Counts Initiating Efavirenz-Containing Regimens

Post Date:

2020-03-12

Publication:

Clinical Infectious Diseases

Background: Severe hepatotoxicity in people with HIV receiving efavirenz (EFV) has been reported. We assessed the incidence and risk factors of hepatotoxicity in women of child-bearing age initiating EFV-containing regimens. Methods: In the PROMISE trial, ART-naïve pregnant women with HIV and CD4...

Tuberculosis in children, adolescents, and women

Post Date:

2020-02-27

Publication:

Lancet Respiratory Medicine

In this Lancet Respiratory Medicine commentary, Dr. Amita Gupta and colleagues note that TB prevalence among children, adolescents, and women isn't well documented. This poses big challenges for the goal of TB elimination.

Whole genome enrichment approach for rapid detection of Mycobacterium tuberculosis and drug resistance-associated mutations from direct sputum sequencing

Post Date:

2020-02-20

Publication:

Tuberculosis

Tuberculosis is the leading cause of death among infectious diseases worldwide. Detection of Mycobacterium tuberculosis (Mtb), using routine culture-based methods is time consuming resulting in delayed diagnosis and poor treatment outcomes. Currently available molecular tests provide faster...

High prevalence of late presentation of ART-naïve perinatally infected children for care in Pune, India

Post Date:

2020-02-19

Countries:

India

Clinical Sites:

BJGMC

Publication:

AIDS Care

AIDS Care : There is an urgent need to identify strategies that improve linkage of perinatally infected ART-naïve children to care, and earlier than what is currently observed.

Applying a risk-benefit analysis to outcomes in tuberculosis clinical trials

Post Date:

2020-02-03

Publication:

Clinical Infectious Diseases

CID: Analyzing efficacy and safety separately in clinical trials could yield misleading study conclusions if there's an increase in efficacy and a decrease in safety

Can Technology & Training Promote Retention in Care & Prevent HIV Transmission?

Post Date:

2016-05-10

When HIV+ mothers are actively engaged in care, they are far less likely to transmit the disease to their babies. And while HIV+ women in India generally seek initial care, maintaining continuity of care can be challenging. One study in India seeks to answer the question: Can a focused...

Study evaluates four-drug TB treatment for HIV/AIDS patients

Post Date:

2016-04-04

Source:

Vaccine News Daily

"Our results even suggest the four-drug strategy is actually doing more harm than isoniazid-alone therapy because study participants found it less tolerable and stopped using it," Dr. Amita Gupta, senior study author and associate professor of medicine and deputy director of the Johns Hopkins...

Feasibility Study Complete on Preventive Therapy for Household Contacts of MDR-TB Patients in Pune, India

Post Date:

2016-03-31

March 31, 2016—Pune, India—The Baltimore-Washington-India Clinical Trials Unit is pleased to announce that the BJGMC Clinical Research Site (BJGMC-CRS) in Pune, India, just finished the feasibility study titled A5300/IMPAACT2003: Study of MDR-TB Cases and their Household Contacts: Operational...

In Many Regions, World Tuberculosis Day is Every Day

Post Date:

2016-03-24

India Assumes the Greatest Burden Each year on March 24, the world pauses to reflect on the devastation that tuberculosis causes globally. TB is preventable and treatable, and it disproportionately and gravely affects resource-limited regions of the world. The World Health Organization reports that...

Proactively treating HIV patients at risk for tuberculosis with multi-drug TB regimens doesn't save more lives

Post Date:

2016-03-20

Source:

Health Canal

The number one killer of HIV patients in resource-limited areas, including parts of Africa and India, is tuberculosis (TB), underscoring the need for optimal treatments and effective strategies to address this deadly co-infection. But TB is harder to detect in HIV-infected patients and...

Proactively treating HIV patients at risk for tuberculosis with multi-drug TB regimens doesn't save more lives

Post Date:

2016-03-18

Source:

Infection Control Today

In what investigators say is a surprise finding, results of a new study appear to strongly affirm the effectiveness of prescribing the anti-tuberculosis drug isoniazid alone — in place of the standard four-drug regimen — to prevent TB and reduce death in

Common TB treatment in HIV: no added benefit?

Post Date:

2016-03-18

Source:

Pharmaceutical Processing Online

In a report on the REMEMBER (Reducing Early Mortality and Early Morbidity by Empiric Tuberculosis Treatment) study—a 10-nation, randomized clinical trial of adult outpatients—investigators concluded that there was no added benefit of using four drugs for TB over just using one drug, isoniazid...

4-drug tuberculosis treatment among HIV/AIDS patients does not save more lives

Post Date:

2016-03-18

Source:

MedIndia

There was no added benefit of using four drugs for tuberculosis over using just one drug, isoniazid, to save lives in people with advanced HIV/AIDS, revealed a report on the so-called REMEMBER (Reducing Early Mortality and Early Morbidity by Empiric Tuberculosis Treatment) study—a 10 nation,...

Multidrug TB prophylaxis not needed in advanced HIV

Post Date:

2016-03-18

Source:

MedPage Today

Patients with advanced HIV infection initiating anti-retroviral therapy who were treated with isoniazid alone to prevent tuberculosis had similar survival rates as patients treated with a standard four-drug anti-tuberculosis regimen in a multi-national, randomized, controlled trial.

Common treatment of TB in advanced HIV patients doesn't save more lives

Post Date:

2016-03-17

Source:

Medical Xpress

In a report on the so-called REMEMBER (Reducing Early Mortality and Early Morbidity by Empiric Tuberculosis Treatment) study—a 10-nation, randomized clinical trial of adult outpatients—investigators concluded that there was no added benefit of using four drugs for TB over just using one drug...

Proactively treating HIV patients at risk for tuberculosis with multidrug TB therapy doesn’t save more lives

Post Date:

2016-03-17

CCGHE at CROI 2016

Post Date:

2016-02-29

JOHNS HOPKINS CENTER FOR CLINICAL GLOBAL HEALTH EDUCATION AT CROI 2016 FEBRUARY 22-25 2016 | BOSTON, MASSACHUSETTS TUESDAY, FEBRUARY 23 Combination HIV Prevention and HIV Incidence in a Ugandan Hotspot Fishing Community. Poster Presentation. Session: HIV Testing and Prevention. Authors: Kagaayi J,...

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...

VIDEO: Amita Gupta, MD, MHS, reviews TB prevention in patients with HIV

Post Date:

2016-02-24

Source:

Infectious Disease News, via Healio

In this video with Healio.com, Amita Gupta, MD, MHS, associate professor medicine and international health and deputy director of the Center for Clinical Global Health Education at Johns Hopkins University School of Medicine, discusses research related to the prevention of tuberculosis in patients...

LEAP Program a Resource for Investigators of New Antiretrovirals

Post Date:

2016-02-03

February 3, 2016—Baltimore, MD—The Johns Hopkins Center for Clinical Global Health Education, the Johns Hopkins Departments of Medicine and Pharmacology and Molecular Sciences, and the University of Liverpool launched a new website for an NIH-funded drug development resource...

Up Close: Matthew Robinson

Post Date:

2016-02-01

Looking for Causes of Fever in India “The most common reason Indians go to the doctor is for fever. The list of potential causes for fever in India and other low and middle income countries in tropical settings is extensive.” Matt Robinson, MD, is a Clinical Fellow whose...

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...

Most commonly used TB test fails to accurately diagnose pregnant, HIV-positive women

Post Date:

2016-01-25

Source:

Infection Control Today

New research finds that the most commonly used test for tuberculosis fails to accurately diagnose TB in up to 50 percent of pregnant women who are HIV positive. The research published early online in the American Thoracic Society’s American Journal of Respiratory and Critical Care Medicine is...

BJGMC Clinical Research Site Observes World AIDS Day

Post Date:

2015-12-14

Pune, India—To mark the struggle of those living with HIV and in commemoration of those who have lost their lives, the Clinical Research Site at Byramjee Jeejeebhoy Government Medical College (BJGMC CRS) participated in the National AIDS Trust’s World AIDS Day ...

Research News

Clinical Research

Pages

Pages

Pages