BJGMC (India)

Overview

Byramjee-Jeejeebhoy Government Medical College (BJGMC) is a Maharashtra State Government-run medical school in Pune, India. BJGMC is affiliated with Sassoon General Hospital (SGH), a 1450-bed hospital, caring for >525,000 outpatients and >60,000 inpatients annually, and serves an urban and surrounding rural catchment area of 7 million people. The school admits 200 new medical students and 130 residents every year and employs more than 200 teaching faculty in all major medical and surgical specialties (medicine, surgery, orthopedics, ophthalmology, ENT, nephrology, endocrinology, plastic surgery, pediatrics, obstetrics and gynecology, and solid organ transplantation). BJGMC also includes a nursing school that admits 50 new students each year. 

BJGMC’s OBGYN department serves more than 6,000 pregnant women annually and performs 8,000 deliveries. The campus includes a specialized center for HIV antiretroviral treatment (ART) run by the Maharashtra State AIDS Control Society as per guidance from National AIDS Control Organization (with more than 15,000 registered HIV patients) and the Indian government’s National Tuberculosis Elimination Program (NTEP) center,  where more than 4,000 patients are evaluated annually for TB.

 

BJGMC-JHU CRS

BJGMC and JHU have collaborated on NIH-funded HIV- and tuberculosis (TB)-related research since 1992. The partnership began investigating the prevention of mother-to-child HIV transmission (PMTCT) in India. The multinational SWEN Trial (2002-2007) at BJGMC was India’s first Phase III randomized HIV clinical trial, demonstrating the efficacy of 6-weeks of low dose infant nevirapine for prevention of HIV transmission through breastfeeding and led directly to changes in the WHO PMTCT clinical care guidelines. Since 2008, when the BJGMC-JHU partnership successfully competed to become a NIH Clinical Trials Unit (CTU), the BJGMC-JHU CRS has enrolled participants in 10 IMPAACT and 11 ACTG clinical trials. The site has also conducted other investigator-initiated HIV and TB studies funded by NIH, CDC, ICMR and private foundations that have complemented the Network studies. The BJGMC-JHU CRS has an established and experienced research team of 150 dedicated, GCP-trained/certified research investigators, clinicians, nurses, counselors, data managers, clinical research officers, pharmacists, as well as a strong community advisory board (CAB), institutional review board (IRB) and clinical trials infrastructure including  laboratory facilities, pharmacy, data management centre, and counselling area.

 

Laboratory Capabilities

The BGJMC CRS lab has established laboratory infrastructure with capacity to perform more than 30 lab analyses required by the NIH trials networks. All protocol-related lab activities (sample receiving, processing, Laboratory Data Management Systems (LDMS) entry, specimen storage, haematology, chemistry, serology, CD4, viral load, HBV, Vitamin D testing, etc.) are performed at the central CRS lab. Additionally, the lab performs processing for specialty immunological assays, PBMCs, interferon gamma release assays (IGRA) such as Quantiferon Gold in tube assay (QGIT) and Cytometric bead array (CBA) assays. It is IQA certified for PBMC cryopreservation and can store samples as required.

Clinical Trials

P2010: Phase III Study of the Virologic Efficacy and Safety...

IMPAACT 2010 is a Phase III, three-arm, randomized, open-label study of HIV-1-infected pregnant women initiating either a...

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A5300/P2003: PHOENIx Feasibility Study

Study of MDR TB Cases and Their Household Contacts: Operational Feasibility to Inform PHOENIx Trial Design

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P1077BF: Breastfeeding Version of the PROMISE Study...

1077BF is a randomized strategy trial, which is part of the PROMISE studies (1077BF, 1077FF, P1084s, and 1077HS). The Promoting...

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A5324: A Randomized, Double-Blinded, Placebo-Controlled...

ACTG A5324 is a phase IV randomized, double-blinded, placebo-controlled study to assess the efficacy of adding Maraviroc (MVC)...

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A5342: Evaluating the Safety, Tolerability, and Effect of a...

The purpose of this study is to evaluate the safety, tolerability, and effect of an experimental human monoclonal antibody...

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