BJGMC-CTU

Studies/Projects
Publications

HIV, Gestational Diabetes and TB in Pregnancy (PraGaTHi)

Post Date:

2023-02-27

Countries:

Clinical Sites:

The purpose of this study is to learn about how diabetes, TB, and HIV affect pregnant women and whether pregnancy, HIV and diabetes increase the risk of acquiring TB during pregnancy and postpartum. During pregnancy, some women will develop a form of diabetes (high blood sugar) called gestational...

1 to 3 HP

Post Date:

2023-01-24

Countries:

India

Indonesia

South Africa

Protocol Title: A Randomized Trial Comparing Treatment Completion of Daily Rifapentine & Isoniazid for One Month (1HP) to Weekly Rifapentine & Isoniazid For 3 Months (3HP) In Persons Living With HIV and in HIV-negative Household Contacts of Recently Diagnosed Tuberculosis Patients, The “One...

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:

India

Clinical Sites:

BJGMC

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...

The Regional Prospective Observational Research In Tuberculosis (Report) India Phase II Common Protocol

Post Date:

2022-01-10

Countries:

Clinical Sites:

Purpose and Scientific Aims The purpose of the RePORT India Phase II Common Protocol is to collect and utilize data and specimens for tuberculosis (TB) research, leveraging the existing infrastructure, processes, and scientific partnerships established under RePORT India consortium. The RePORT...

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. ...

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...

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,...

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...

P1077BF: Breastfeeding Version of the PROMISE Study (Promoting Maternal and Infant Survival Everywhere)

Post Date:

2010-02-02

Countries:

India

This trial was terminated November 6, 2019. This multi-country trial is being conducted in India, Malawi, South Africa, Tanzania, Uganda, Zambia, and Zimbabwe, conducted under the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network and funded...

P1077FF: Formula Feeding Version of the PROMISE Study (Promoting Maternal and Infant Survival Everywhere)

Post Date:

2010-02-02

Countries:

India

This trial was terminated November 6, 2019. This multi-country trial is being conducted in India, Malawi, South Africa, Tanzania, Uganda, Zambia, and Zimbabwe, under the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network and funded by the U.S...

A5225: Phase I/II Dose-Finding Study of High-Dose Fluconazole Treatment in AIDS-Associated Cryptococcal Meningitis

Post Date:

2009-04-22

Countries:

India

Clinical Sites:

BJGMC

This trial was terminated in March 2015; it was conducted under the AIDS Clinical Trials Group (ACTG) and funded by the U.S. National Institutes of Health. This multi-country study was conducted in India, Kenyam Peru, South Africa, Thailand, Uganda, United States, and...

P1070: Dose-Finding and Pharmacogenetic Study of Efavirenz in HIV-Infected and HIV/TB Co-Infected Infants and Children ≥ 3 Months to < 36 Months of Age

Post Date:

2008-12-05

Countries:

Clinical Sites:

This study ended March 10, 2015. This multi-country trial was conducted in India, South Africa, Tanzania, Uganda, Zambia, and Zimbabwe, under the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network and funded by the U.S. National Institutes of...

BJGMC-JHU Fogarty HIV-TB Training Program

Post Date:

2007-01-01

Countries:

India

Clinical Sites:

BJGMC

Funded by the Fogarty International Center at the National Institutes of Health, the JHU Fogarty program has nearly 20 years of success with providing training, professional development, and mentorship to clinicians and scientists in low and middle income countries. CCGHE's latest efforts in...

P1060: Phase II, parallel, randomized, clinical trials comparing the responses to initiation of NNRTI-based antiretroviral therapy in HIV-infected infants who have not previously received Single dose Nevirapine for prevention of Mother-to-child HIV...

Post Date:

2006-03-27

Countries:

India

Clinical Sites:

BJGMC

This study ended June 28, 2015. This multi-country trial was conducted in India, Malawi, South Africa, Tanzania, Uganda, Zambia, and Zimbabwe under the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network and funded by the U.S. National Institutes of Health...

A5207: Maintaining Options for Mothers Study (MOMS): A Phase II Randomized Comparison of Three Antiretroviral Strategies Administered for 7 or 21 Days to Reduce the Emergence of Nevirapine Resistant HIV-1 Following a Single Intrapartum Dose of Nevirapine

Post Date:

2004-12-20

Countries:

This study was terminated January 16, 2014; it was conducted under the AIDS Clinical Trials Group (ACTG) and funded by the U.S. National Institutes of Health. A major disadvantage of giving SD NVP is the potential for maternal development of NVP resistance and additional...

A5175: PEARLS Evaluation of the Efficacy of Once-Daily Protease Inhibitor and Once-Daily Non-Nucleoside Reverse Transcriptase Inhibitor- Containing Therapy Combinations for Initial Treatment of HIV-1 Infected Individuals

Post Date:

2004-07-27

Countries:

India

Full Title: A Phase IV, Prospective, Randomized, Open-Label Evaluation of the Efficacy of Once-Daily Protease Inhibitor and Once Daily Non-Nucleoside Reverse Transcriptase Inhibitor Containing Therapy Combinations for Initial Treatment of HIV-1 Infected Individuals from Resource-Limited...

Mother-to-Child Transmission (MTCT) of HIV: India SWEN Study

Post Date:

2002-06-07

Countries:

India

Clinical Sites:

BJGMC

This study was officially terminated August 2018. Primary and secondary analyses of the India SWEN study, an NIH-funded phase III randomized controlled trial of an extended nevirapine prophylaxis regimen among 783 HIV-infected pregnant women and their...

Challenges with the use of Xpert HPV as a screening tool for oral HPV among people living with HIV (PLHIV): experiences from Pune, India

Post Date:

2023-05-04

Countries:

India

Clinical Sites:

BJGMC

Publication:

BMC Infectious Diseases

Background: People living with HIV (PLHIV) are at higher risk for human papillomavirus (HPV)-related oropharyngeal cancers compared to the general population. Xpert HPV test is a polymerase chain reaction (PCR) assay capable of rapid HPV detection. Performing the assay requires minimal intervention...

Operational challenges undermine the WHO TB symptom screen in pregnant women in India

Post Date:

2023-04-26

Countries:

India

Clinical Sites:

BJGMC

Publication:

Open Forum Infectious Diseases

Background. Pregnancy increases both a woman's risk of developing tuberculosis (TB) and her likelihood to seek health care. A symptom screen that is effective during pregnancy would therefore be valuable. We assessed a World Health Organization (WHO)-recommended TB symptom screen in an antenatal...

Inflammatory profile associated with insulin resistance in non-overweight versus overweight people living with HIV (PLWH)

Post Date:

2023-04-21

Countries:

India

Clinical Sites:

BJGMC

Publication:

Diabetes & Metabolic Syndrome

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...

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

Post Date:

2022-12-22

Countries:

India

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:

India

Clinical Sites:

BJGMC

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...

Willingness of Caregivers to Give Preventive Therapy to Children Living in Households of Patients with Rifampin-resistant Tuberculosis

Post Date:

2022-10-26

Countries:

India

Clinical Sites:

BJGMC

Publication:

The International Journal of Tuberculosis and Lung Disease

BACKGROUND Pediatric household contacts (HHCs) of patients with multidrug-resistant TB (MDR-TB) are at high risk of infection and active disease. Evidence of caregiver willingness to give MDR-TB preventive therapy (TPT) to children is limited. METHODS This was a cross-sectional study of HHCs of...

Concomitant pulmonary disease is common among patients with extrapulmonary TB

Post Date:

2022-08-12

Countries:

India

Clinical Sites:

BJGMC

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.

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

Post Date:

2022-07-31

Countries:

India

Clinical Sites:

BJGMC

Publication:

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...

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

Post Date:

2022-07-13

Countries:

India

Clinical Sites:

BJGMC

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:

India

Clinical Sites:

BJGMC

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...

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

Post Date:

2022-07-01

Countries:

India

Clinical Sites:

BJGMC

Publication:

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...

A Novel Computer-Based Virtual Counselor-Delivered Alcohol Reduction Intervention : Acceptability, Adaptability and Feasibility among Adults with HIV or TB in Indian Clinical Settings

Post Date:

2022-05-27

Countries:

India

Clinical Sites:

BJGMC

Publication:

JMIR Formative Research

Background: Unhealthy alcohol use is associated with increased morbidity and mortality among persons with HIV and tuberculosis (TB). Computer-based interventions (CBIs) can reduce unhealthy alcohol use, are scalable, and may improve outcomes among patients with HIV or TB. Objective: We assessed the...

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

Post Date:

2022-05-11

Countries:

India

Clinical Sites:

BJGMC

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...

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:

India

Clinical Sites:

BJGMC

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...

Implementation of the Comprehensive Unit-based Safety Program to Improve Infection Prevention and Control Practices in Four Neonatal Intensive Care Units in Pune, India

Post Date:

2022-01-06

Countries:

India

Clinical Sites:

BJGMC

Publication:

Frontiers in Pediatrics

Objective: To implement the Comprehensive Unit-based Safety Program (CUSP) in four neonatal intensive care units (NICUs) in Pune, India, to improve infection prevention and control (IPC) practices. Design: In this quasi-experimental study, we implemented CUSP in four NICUs in Pune, India, to...

A Case Study of Intra-Family Clustering of COVID-19 in India

Post Date:

2021-08-18

Countries:

India

Publication:

European Journal of Pharmaceutical and Medical Research

Background: With unprecedented COVID-19 disease-related morbidity and mortality globally, understanding the transmission dynamics of this disease is of paramount importance for disease control efforts. Despite the lockdown in India, there has been reported an ever-increasing number of infected...

Diabetes Mellitus and Tuberculosis Treatment Outcomes in Pune, India

Post Date:

2021-04-01

Countries:

India

Clinical Sites:

BJGMC

Publication:

Open Forum Infectious Diseases

Background Diabetes mellitus (DM) increases the risk of tuberculosis (TB) disease. Knowledge of the impact of DM on TB treatment outcomes is primarily based on retrospective studies. Methods We conducted a prospective cohort study of new pulmonary TB patients with and without DM (TB-DM and TB only...

Association of Vegetable and Animal Flesh Intake with Inflammation in Pregnant Women from India

Post Date:

2020-12-08

Countries:

India

Publication:

MDPI

In pregnant women, studies are lacking on the relationship of vegetable and animal flesh (poultry, red meat and seafood) intake with inflammation...

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...

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

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