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.

Publications

Pediatric tuberculosis in young children in India: a prospective study

Post Date:

2013-11-11

|

Countries:

|

Clinical Sites:

Publication:

BioMed Research International

Background: India has one of the highest tuberculosis (TB) burdens globally. However, few studies have focused on TB in young children, a vulnerable population, where lack of early diagnosis results in poor outcomes. Methods: Young children (≤ 5 years) with...

Patterns of TB drug-resistance in a tertiary care facility in Pune, India

Post Date:

2013-07-18

|

Countries:

Publication:

Clinical Microbiology

Introduction:Globally, the emergence of multi-drug resistant tuberculosis (MDRTB) (defined as resistance to isoniazid (INH) and rifampicin (RIF) and extensively drug resistant (XDR-TB) (defined as resistance to INH, RIF, any fluoroquinolone and to at least one of the three injectable second...

Growth patterns among HIV-exposed infants receiving nevirapine prophylaxis in Pune, India

Post Date:

2012-10-31

|

Countries:

|

Clinical Sites:

Publication:

BMC Infectious Diseases

Background: India has among the highest rates of infant malnutrition. Few studies investigating the growth patterns of HIV-exposed infants in India or the impact of timing of HIV infection on growth in settings such as India exist. Methods: We used data from...

Vitamin D deficiency is common among HIV-infected breastfeeding mothers in Pune, India, but not associated with mother-to-child HIV transmission

Post Date:

2012-10-01

|

Countries:

|

Clinical Sites:

Publication:

HIV Clinical Trials

A recent report from Tanzania demonstrated an increased risk of being HIV infected or of dying at birth among children born to breastfeeding mothers with low baseline vitamin D levels. We conducted a nested case-control study among HIV-infected pregnant women in western India to confirm the...

Authors’ response to Hanrahan et al CID article

Post Date:

2012-05-15

|

Countries:

|

Clinical Sites:

Publication:

Clinical Infectious Diseases

Reply to letter

Predictors of mortality in hospitalized children with pandemic H1N1 influenza 2009 in Pune, India

Post Date:

2012-04-15

|

Countries:

|

Clinical Sites:

Publication:

Indian Journal of Pediatrics

Objective: To analyse the factors associated with increased mortality among Indian Children with H1N1. Methods: Data were abstracted from available hospital records of children less than 12 y of age, who were admitted to Sassoon General Hospital in Pune, India, with...

Determination of a reference interval in a population

Post Date:

2012-02-01

|

Countries:

Publication:

National Medical Journal of India

The reference interval is the most widely used medical decision-making tool that separates healthy from diseased individuals. We briefly discuss the methods used to determine reference interval and its limitations.

Early mortality in adults initiating antiretroviral therapy (ART) in low- and middle-income countries (LMIC): a systematic review and meta-analysis

Post Date:

2011-12-15

Publication:

PLOS One

Background: We systematically reviewed observational studies of early mortality post-antiretroviral therapy (ART) initiation in low- and middle-income countries (LMIC) in Asia, Africa, and Central and South America, as defined by the World Bank, to summarize what is known. ...

Impact of maternal human immunodeficiency virus infection on pregnancy and birth outcomes in Pune, India

Post Date:

2011-12-15

|

Countries:

|

Clinical Sites:

Publication:

AIDS Care

Little is known about birth outcomes for HIV-infected women in India. We examine maternal and neonatal birth outcomes in HIV-infected women within the context of enhanced pre-natal care associated with a randomized clinical trial conducted in Pune, India. Birth outcomes of 212 HIV-infected...

Symptom screening among HIV-infected pregnant women is acceptable and has high negative predictive value for active tuberculosis

Post Date:

2011-11-15

|

Countries:

|

Clinical Sites:

Publication:

Clinical Infectious Diseases

Symptom screening is a recommended component of intensified case-finding (ICF) for pulmonary tuberculosis (TB) among HIV-infected individuals. Symptomatic individuals are further investigated to either exclude or diagnose pulmonary TB, thus reducing the number of individuals requiring costly...

High rates of all-cause and gastroenteritis-related hospitalization morbidity and mortality among HIV-exposed Indian infants

Post Date:

2011-07-15

|

Countries:

|

Clinical Sites:

Publication:

BMC Infectious Diseases

Background: HIV-infected and HIV-exposed, uninfected infants experience a high burden of infectious morbidity and mortality. Hospitalization is an important metric for morbidity and is associated with high mortality, yet, little is known about rates and causes of hospitalization among these...

A comparison of online versus on-site training in health research methodology: A randomized study

Post Date:

2011-06-17

|

Countries:

Publication:

BMC Medical Education

Background: Distance learning may be useful for building health research capacity. However, evidence that it can improve knowledge and skills in health research, particularly in resource-poor settings, is limited. We compared the impact and acceptability of teaching two distinct content areas...

Twelve month follow-up of the SWEN randomized controlled trials: Differential impact of extended-dose nevirapine on mother-to-child transmission and infant death by maternal CD4 cell count

Post Date:

2011-03-27

|

Countries:

|

Clinical Sites:

Publication:

AIDS Care

Objectives: We previously reported combined analysis of 6-week and 6-month endpoints of three randomized controlled trials [Six Week Extended Dose Nevirapine (SWEN) trials] that compared extended-dose nevirapine through 6 weeks of age to single-dose nevirapine to prevent HIV transmission via...

Predictors of retention among men attending STI clinics in HIV prevention programs and research: A case control study in Pune, India

Post Date:

2011-03-11

|

Countries:

|

Clinical Sites:

Publication:

PLOS One

Background: Retention is critical in HIV prevention programs and clinical research. We studied retention in the three modeled scenarios of primary prevention programs, cohort studies and clinical trials to identify predictors of retention. Methodology/Principal Findings: Men attending Sexually...

Maternal tuberculosis: a risk factor for mother-to-child transmission of human immunodeficiency virus

Post Date:

2011-02-01

|

Countries:

|

Clinical Sites:

Publication:

The Journal of Infectious Diseases

Background: Maternal human immunodeficiency virus (HIV) RNA load, CD4 cell count, breast-feeding, antiretroviral use, and malaria are well-established factors associated with mother-to-child transmission (MTCT) of HIV; the role of maternal tuberculosis (TB), however, has not been well...

Extended-dose nevirapine to 6 weeks of age for infants to prevent HIV transmission via breastfeeding in Ethiopia, India, and Uganda: an analysis of three randomized controlled trials

Post Date:

2009-07-26

|

Countries:

|

Clinical Sites:

Publication:

The Lancet

Background: UNICEF/WHO recommends that infants born to HIV-infected mothers who do not have access to acceptable, feasible, affordable, sustainable, and safe replacement feeding should be exclusively breastfed for at least 6 months. The aim of three trials in Ethiopia, India, and Uganda was...

Nevirapine resistance and breast-milk HIV transmission: effects of single and extended-dose nevirapine prophylaxis in subtype C HIV-infected infants

Post Date:

2009-01-01

|

Countries:

|

Clinical Sites:

Publication:

PLOS One

Background: Daily nevirapine (NVP) prophylaxis to HIV-exposed infants significantly reduces breast-milk HIV transmission. We assessed NVP-resistance in Indian infants enrolled in the “six-week extended-dose nevirapine” (SWEN) trial who received single-dose NVP (SD-NVP) or SWEN for prevention...

High risk for occupational exposure to HIV and utilization of post-exposure prophylaxis in a teaching hospital in Pune, India

Post Date:

2008-10-21

|

Countries:

|

Clinical Sites:

Publication:

BMC Infectious Diseases

Background: The risk for occupational exposure to HIV has been well characterized in the developed world, but limited information is available about this transmission risk in resource-constrained settings facing the largest burden of HIV infection. In addition, the feasibility and utilization of...

The Indian pediatric HIV epidemic: a systematic review

Post Date:

2008-09-15

|

Countries:

Publication:

Current HIV Research

Despite an estimated 70,000 Indian children living with HIV infection, little is known about India's pediatric HIV epidemic. Generalizations about epidemiology, natural history, and treatment outcomes from other resource-limited settings (RLS) may be inaccurate for several biologic and social...

Modeling maternal infant HIV transmission in the presence of breast-feeding with an imperfect test

Post Date:

2007-12-15

|

Countries:

|

Clinical Sites:

Publication:

Biometrics

An important public health question is to determine the probabilities of perinatal HIV transmission and when it occurs, whether antepartum, intrapartum, or postpartum through breastfeeding. However, this is a difficult problem because the presence of HIV infection in an infant can only be...

Pages