BJGMC

Clinical Sites:

This study was terminated January 3, 2019. It was funded by the Fogarty International Center at the U.S. National Institutes of Health. Young children infected with M.tuberculosis can rapidly progress to pulmonary and extrapulmonary disease with high rates of mortality and...

The Human Virome in Health and Disease

Post Date:

2016-02-21

Countries:

Clinical Sites:

This study was terminated in September 2020. This study is part of the Antimicrobial Resistance study referenced below, Some samples were used from the Cohort for Tuberculosis Research by the Indo-US Medical Partnership (C-TRIUMPH), under the Regional...

Whole Genome Sequencing of Clinical Isolates from Patients with Multidrug Resistant Tuberculosis in India

Post Date:

2015-11-12

Countries:

Clinical Sites:

This study was terminated August 9, 2019. Comparative genomic analysis using whole genome sequencing (WGS) offers an opportunity to understand the specific mutations associated with drug resistance and the phenotypic behavior of TB. As treatment programs incorporate more...

Residual Respiratory Impairment Following Pulmonary Tuberculosis

Post Date:

2015-09-13

Countries:

Clinical Sites:

This study is conducted by 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. Many TB patients have...

A5300/IMPAACT2003: Study of MDR TB Cases and Their Household Contacts: Operational Feasibility to Inform PHOENIx Trial Design

Post Date:

2015-09-01

Countries:

Clinical Sites:

This clinical trial was terminated July 18, 2017. It was a study conducted under both the AIDS Clinical Trial Group (ACTG) and the the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network, and funded by the U.S. National Institutes of Health. Dr...

Prevalence Survey of Risk Factors for Tuberculosis and Non-communicable Diseases in an HIV-positive Population in Pune, India

Post Date:

2015-08-17

Countries:

Clinical Sites:

This study is conducted under the TREAT Asia Network and funded by amfAR. The primary objective of this study is to assess the prevalence of risk factors for tuberculosis and non-communicable diseases (NCDs)--coronary artery disease and diabetes mellitus--...

A5290: A Randomized, Phase 2b Study of a Double-Dose Lopinavir/Ritonavir-Based Antiretroviral Regimen with Rifampin-Based Tuberculosis Treatment versus a Standard-Dose Lopinavir/Ritonavir-Based Antiretroviral Regimen with Rifabutin-Based Tuberculosis...

Post Date:

2015-07-07

Countries:

Clinical Sites:

This study was terminated February 23, 2016; it was conducted under the AIDS Clinical Trials Group (ACTG) and funded by the U.S. National Institutes of Health.. Full Title: A5290, A Randomized, Phase 2b Study of a Double-Dose Lopinavir/Ritonavir-Based Antiretroviral Regimen...

Bacterial Antimicrobial Resistance Patterns in Pune, India: Substudy on Community Health-Seeking Behavior Among Patients Admitted with Acute Febrile Illness

Post Date:

2015-05-28

Countries:

Clinical Sites:

Objectives: To describe the patterns of health-care seeking behavior and prior outpatient care among patients admitted with acute febrile illness to Sassoon Hospital To determine the effects of outpatient behaviors and prior treatments on the antimicrobial...

Barriers for Intervention to Prevent Occupationally Acquired Tuberculosis in Healthcare Workers

Post Date:

2015-05-21

Countries:

Clinical Sites:

This study was terminated April 20, 2017; it was funded by the Fogarty International Center at the U.S. National Institutes of Health. Observational study to assess the current status of implementation of interventions for preventing occupationally acquired...

Risk of Tuberculosis among Health Care Workers and Trainees in a Tertiary-care Hospital in Pune, India

Post Date:

2015-04-15

Countries:

Clinical Sites:

This study was terminated April 24, 2018. It was funded by the Fogarty International Center at the U.S. National Institutes of Health. A retrospective study of health care workers (HCWs) was conducted by investigators of the Byramjee Jeejeebhoy Medical and...

Inflammation in HIV-infected Pregnant Women: Relationship with Diet, Gut Microbiome and Preterm Birth

Post Date:

2014-10-28

Countries:

Clinical Sites:

This study was terminated May 7, 2018. P regnancy is a state of relative immunosuppression in order to protect the fetus from being rejected. It has also been shown that the Th-1 helper cell response, which is normally necessary for overcoming TB infection...

Predictive Value of TB-symptom Screen in HIV-infected and HIV-uninfected Pregnant Women in Pune, India

Post Date:

2014-10-28

Countries:

Clinical Sites:

This study was terminated July 17, 2017. This is a cross sectional observational study will be conducted at BJGMC to establish what the predictive value of the WHO TB symptom screen is in pregnant women in India. We hypothesize that the WHO TB symptom...

Diagnosis of Tuberculosis Infection and Th1 Immune Response in Pregnant Women in India

Post Date:

2014-09-01

Countries:

Clinical Sites:

This study was terminated April 16, 2018. Tuberculosis (TB) disease is a major cause of mortality among Indian women of reproductive age; approximately 20-50% of women in India are latently infected with Mycobacterium tuberculosis (MTB). Due to immune...

Impact of Immune Changes of HIV and Stages of Pregnancy on Tuberculosis

Post Date:

2014-09-01

Countries:

Clinical Sites:

This is the Parent Study for CCGHE’s PRACHITI (PRegnancy And CHanges In TuberculosIs) effort. It's supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development at the U.S. National Institutes of Health. Purpose: TB is a...

A5279: Phase III Clinical Trial of Ultra-Short-Course Rifapentine/Isoniazid for the Prevention of Active Tuberculosis in HIV-infected Individuals with Latent Tuberculosis Infection

Post Date:

2014-06-30

Countries:

Clinical Sites:

This study ended April 27, 2015; it was conducted under the AIDS Clinical Trials Group (ACTG) and funded by the U.S. National Institutes of Health. Dr. Amita Gupta was Protocol Co-Vice Chair for this multinational clinical trial being conducted in Botswana, Brazil, Haiti,...

Evaluation of Longitudinal Blood Culture Isolates from BJ Medical College in Pune, India, 2003-2013

Post Date:

2014-06-16

Countries:

Clinical Sites:

This study was terminated July 31, 2014. Antibiotic resistance is a serious global problem and is caused by multiple factors which have led to difficulty in the management of life-threatening, multi-drug resistant (MDR) bacterial bloodstream infections. The knowledge of antibiotic resistance...

ART Study 1: Database: Epidemiology of HIV/AIDS and Associated Comorbidities in a Public Antiretroviral Treatment (ART) Clinic at BJGMC in Pune

Post Date:

2014-06-14

Countries:

Clinical Sites:

Hinduja Hospital

Since 2004, the National AIDS Control Program of India has been rolling out free antiretroviral therapy. Byramjee Jeejeebhoy Government Medical College (BJGMC), located in Pune, India, is now the largest HIV clinic in India, with over 26,000 adult and pediatric patients registered since 2005...

Optimizing Treatment to Improve TBM Outcomes in Children

Post Date:

2014-05-01

Countries:

Clinical Sites:

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:

Clinical Sites:

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...

Screening for Gender Based-violence (GBV) and Feasibility and Acceptability of mHealth GBV Screening and Support Tools

Post Date:

2014-03-26

Countries:

Clinical Sites:

This study was terminated February 14, 2017. Gender-based violence (GBV) is a significant public health issue in India, with estimates that over a third of women and girls are impacted at some point in their lifetime. This pilot qualitative study examined the feasibility of enhancing GBV prevention...

Empirical tuberculosis therapy versus isoniazid in adult outpatients with advanced HIV initiating antiretroviral therapy (REMEMBER): a multicountry open-label randomised controlled trial

Post Date:

2016-03-19

Countries:

Clinical Sites:

Publication:

The Lancet

Background: Mortality within the first 6 months after initiating antiretroviral therapy is common in resource-limited settings and is often due to tuberculosis in patients with advanced HIV disease. Isoniazid preventive therapy is recommended in HIV-positive adults, but subclinical...

Cohort for Tuberculosis Research by the Indo-US Medical Partnership (C-TRIUMPH): protocol for a multicentric prospective observational study

Post Date:

2016-02-25

Countries:

Clinical Sites:

Publication:

BMJ Open

Introduction: Tuberculosis disease (TB) remains an important global health threat. An evidence-based response, tailored to local disease epidemiology in high-burden countries, is key to controlling the global TB epidemic. Reliable surrogate biomarkers that predict key active disease and...

Cost effectiveness of isoniazid preventive therapy for HIV-infected pregnant women in India

Post Date:

2016-01-01

Countries:

Clinical Sites:

Publication:

International Journal of Tuberculosis and Lung Disease

Background: India has a high burden of active tuberculosis (TB) and human immunodeficiency virus (HIV) infection. Pregnancy increases the risks of developing TB in HIV-infected women. Isoniazid preventive therapy (IPT) reduces progression to TB, but may increase costs and hepatotoxicity. The...

Pediatric tuberculous meningitis: model-based approach to determining optimal doses of anti-tuberculosis drugs for children

Post Date:

2015-10-22

Countries:

Clinical Sites:

Publication:

Clinical Pharmacology and Therapeutics

Pediatric tuberculous meningitis (TBM) is a highly morbid, often fatal disease. Standard treatment includes isoniazid, rifampin, pyrazinamide, and ethambutol. Current rifampin dosing achieves low cerebrospinal fluid (CSF) concentrations, and CSF penetration of ethambutol is poor. In adult...

RePORT International: advancing tuberculosis biomarker research through global collaboration

Post Date:

2015-10-15

Countries:

Clinical Sites:

Publication:

Clinical Infectious Diseases

Progress in tuberculosis clinical research is hampered by a lack of reliable biomarkers that predict progression from latent to active tuberculosis, and subsequent cure, relapse, or failure. Regional Prospective Observational Research for Tuberculosis (RePORT) International represents a...

Soluble CD14: An independent biomarker for risk of HIV mother-to-child transmission in setting of pre- and post-exposure antiretroviral prophylaxis

Post Date:

2015-10-06

Countries:

Clinical Sites:

Publication:

The Journal of Infectious Diseases

Elevated soluble CD14 (sCD14) concentrations, a marker of monocyte activation, predicts adverse outcomes in human immunodeficiency virus (HIV)-infected adults. To examine the association of sCD14 concentrations with the risk of mother-to-child transmission (MTCT) of HIV, we nested a case-...

Pre-cART elevation of CRP and CD4+ T-cell immune activation associated with HIV clinical progression in a multinational case-cohort study

Post Date:

2015-10-01

Countries:

Clinical Sites:

Publication:

Journal of Acquired Immune Deficiency Syndromes

Background: Despite the success of combination antiretroviral therapy (cART), a subset of HIV-infected patients who initiate cART develop early clinical progression to AIDS; therefore, some cART initiators are not fully benefitted by cART. Immune activation pre-cART may predict clinical...

Contraceptive use and factors associated with postpartum surgical sterilization among HIV-infected women in Pune, India

Post Date:

2015-08-21

Countries:

Clinical Sites:

Publication:

Journal of HIV/AIDS & Social Services

The authors desire to better understand contraceptive practices and factors associated with surgical tubal ligation (STL) among HIV-infected women. Secondary data were obtained from HIV-infected women enrolled in a National Institutes of Health–funded clinical trial assessing the efficacy of...

Concurrent anemia and elevated CRP predicts HIV clinical treatment failure, including TB, post-antiretroviral therapy initiation

Post Date:

2015-07-01

Countries:

Clinical Sites:

Publication:

Clinical Infectious Diseases

Background: Anemia is a known risk factor for clinical failure following antiretroviral therapy (ART). Notably, anemia and inflammation are interrelated, and recent studies have associated elevated C-reactive protein (CRP), an inflammation marker, with adverse human immunodeficiency virus (...

Vitamin D deficiency and risk of postpartum tuberculosis among HIV-infected breastfeeding mothers in India

Post Date:

2015-03-15

Countries:

Clinical Sites:

Publication:

International Journal of Tuberculosis and Lung Disease

Some studies have associated low vitamin D levels with the risk of tuberculosis (TB), but its association in human immunodeficiency virus (HIV) infected mothers in a TB-endemic region has not been well studied. We conducted a nested 1:2 case-control study among HIV-infected mothers in western...

Pre-antiretroviral therapy selenium status predicts WHO stages 3, 4 or death but not virologic failure post-antiretroviral therapy

Post Date:

2014-11-13

Countries:

Clinical Sites:

Publication:

Nutrients

A case-cohort study, within a multi-country trial of antiretroviral therapy (ART) efficacy (Prospective Evaluation of Antiretrovirals in Resource Limited Settings (PEARLS)), was conducted to determine if pre-ART serum selenium deficiency is independently associated with human immunodeficiency...

Source case investigation for children with TB disease in Pune, India

Post Date:

2014-08-27

Countries:

Clinical Sites:

Publication:

Tuberculosis Research and Treatment

Setting. Contact tracing is broadly encouraged for tuberculosis (TB) control. In many high-burden countries, however, little effort is made to identify contacts of newly diagnosed TB patients. This failure puts children, many of whom live in poor crowded communities, at special risk. ...

25-Hydroxyvitamin D insufficiency and deficiency is associated with HIV disease progression and virological failure post-antiretroviral therapy initiation in diverse multinational settings

Post Date:

2014-07-15

Countries:

Clinical Sites:

Publication:

The Journal of Infectious Diseases

Background: Low 25-hydroxyvitamin D (25(OH)D) has been associated with increased HIV mortality, but prospective studies assessing treatment outcomes after combination antiretroviral therapy (cART) initiation in resource-limited settings are lacking. Methods...

Impact of maternal hepatitis B virus coinfection on mother-to-child transmission of HIV

Post Date:

2014-07-15

Countries:

Clinical Sites:

Publication:

HIV Medicine

Objectives: Despite high hepatitis B virus (HBV) endemicity in various resource-limited settings (RLSs), the impact of maternal HIV/HBV coinfection on infant health outcomes has not been defined. We aimed to assess the prevalence of HBV coinfection among HIV-infected pregnant women and its...

Challenges to disclosure of HIV status to perinatally infected children: a study of caregiver perspectives in Pune, India

Post Date:

2014-06-15

Countries:

Clinical Sites:

Publication:

Journal of Pediatric Infectious Diseases

Effective guidelines around disclosure of HIV status are lacking and limited data from India reveal low rates of HIV disclosure to perinatally infected children. This study, conducted in Pune, India, attempts to understand the experiences of caregivers of perinatally infected children around the...

Change in Vitamin D levels occurs early after antiretroviral therapy initiation and depends on treatment regimen in resource-limited settings

Post Date:

2014-04-21

Countries:

Clinical Sites:

Publication:

PLOS One

Background: Vitamin D has wide-ranging effects on the immune system, and studies suggest that low serum vitamin D levels are associated with worse clinical outcomes in HIV. Recent studies have identified an interaction between antiretrovirals used to treat HIV and reduced serum vitamin D...

Pregnancy differentially impacts performance of latent tuberculosis diagnostics in a high-burden setting

Post Date:

2014-03-21

Countries:

Clinical Sites:

Publication:

PLOS One

Background: Targeted screening for latent TB infection (LTBI) in vulnerable populations is a recommended TB control strategy. Pregnant women are at high risk for developing TB and likely to access healthcare, making pregnancy an important screening opportunity in developing countries. The...

Maternal pneumococcal capsular IgG antibodies and transplacental transfer are lower in South Asian HIV-infected mother-infant pairs

Post Date:

2014-03-14

Countries:

Clinical Sites:

Publication:

Vaccine

Background: Our understanding of the mother-to-child transfer of serotype-specific pneumococcal antibodies is limited in non-immunized, HIV-positive women. Methods: We compared geometric mean antibody concentrations (GMCs), geometric mean transplacental...

Modifiable risk factors associated with tuberculosis disease in children in Pune, India

Post Date:

2014-02-15

Countries:

Clinical Sites:

Publication:

International Journal of Tuberculosis and Lung Disease

Setting: India accounts for the largest burden of tuberculosis (TB) worldwide, with 26% of the world's cases. Objective: To assess the association between novel modifiable risk factors and TB in Indian children. Design: Cases were children aged...

Improving diagnostic capability for HPV disease internationally within the NIH-NIAID-Division of AIDS Clinical Trial Networks

Post Date:

2013-12-15

Countries:

Clinical Sites: