Study/Projects - Tuberculosis

HIV, Gestational Diabetes and TB in Pregnancy (PraGaTHi)

Post Date: 
2023-02-27
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
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...

A multicenter Phase II/ III double-blind, randomized, placebo controlled study to evaluate the efficacy and safety of VPM1002 in the prevention of tuberculosis (TB) recurrence in pulmonary TB patients after successful TB treatment in India.

Post Date: 
2022-05-08
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
To evaluate the efficacy of VPM1002 in prevention of TB recurrence in former pulmonary TB patients who have successfully completed ATT and were declared cured. Secondary Objective To evaluate the safety of VPM1002 in former TB patients who have successfully completed ATT and were declared as cured...

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

Post Date: 
2022-01-10
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
Hinduja Hospital
NIRT
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...

Innovative modelling for predicting TB treatment outcomes in global cohorts

Post Date: 
2021-12-19
Our overarching hypothesis is that clinical and laboratory risk factors for the adversity be treatment outcomes of failure, recurrence and mortality are heterogeneous and time-dependent. Precision medicine approaches supported by Machine learning techniques that overcome the limitations of...

Creating a Hope: A Mixed-Method Approach to Identify Most Acceptable Evidence-Based Psycho-Social Intervention to Improve the Retention in Care among Indian Youth Diagnosed with Multi-Drug Resistant TB (MDR-TB)

Post Date: 
2021-11-02
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
PURPOSE: Adolescents and youths with MDR/RR tuberculosis reported social isolation, stigmatization, depression, and poor self-esteem highlighting the importance of psychosocial support during tuberculosis treatment phase. Addressing the psycho-social need of youths, by identifying youth friendly...

“Bridging the Gaps”: Understanding the Barriers and Facilitators in the Tuberculosis Prevention Care Cascade for Optimizing Isoniazid Preventive Therapy Uptake among Adults Living with HIV in India, a Mixed-Method Approach

Post Date: 
2021-11-02
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
PURPOSE: The isoniazid preventive therapy policy has achieved limited success in low and middle-income countries. With limited empirical research exploring the barriers to suboptimal IPT uptake, it is important to understand this knowledge gap. Also, limited programmatic strategies exist to address...

Childhood ‘Omics’ and Mycobacterium tuberculosis-derived BiOsignatures (COMBO) for TB diagnosis

Post Date: 
2021-10-18
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
The overall objective of the project is to identify Mtb- and/or host-derived biosignatures in children that can achieve World Health Organization (WHO) target product profile (TPP) accuracy thresholds for a non-sputum biomarker-based triage or diagnostic test for childhood TB. We hypothesize that...

Epidemiologic Factors Associated with TB Treatment Outcomes Across Report International Consortia

Post Date: 
2021-08-12
   |   
Countries: 
Brazil
China
India
Indonesia
Philippines
South Africa
Rationale: RePORT International was designed to enable cross-consortium data analysis. Now that a large number of consortium sites have completed participant enrollment in Common Protocol Cohort A, we can proceed with large-scale analysis of aligned RePORT data. The current study will harmonize and...

Biomarkers of Hepatotoxicity in Pregnant and Postpartum Women Living With HIV and Latent TB

Post Date: 
2021-06-21
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
Primary objectives: 1. Quantify INH metabolite PK in pregnant and postpartum WLWH receiving IPT, and compare INH metabolites exposures between cases and controls. 1. Identify biomarkers of hepatotoxicity in pregnant and postpartum WLWH receiving IPT. 2. Model relationships between drug metabolite...

A5362: A Phase IIc Trial of Clofazimine- and Rifapentine-Containing Treatment Shortening Regimens in Drug-Susceptible Tuberculosis: The CLO-FAST Study

Post Date: 
2021-06-15
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
Primary Hypothesis A 3-month regimen of rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) with clofazimine (CFZ) dosed as 100 mg daily with a 2-week 300 mg daily loading dose (Arm 1) will demonstrate early efficacy (time to 12-week liquid culture conversion) relative to standard of care (SOC) (...

The Pharmacokinetics, Safety and Acceptability of New Child-Friendly Formulations of Clofazimine and Moxifloxacin in Children Routinely Treated for Rifampicin-Resistant Tuberculosis (CATALYST)

Post Date: 
2021-04-26
   |   
Countries: 
India
Philippines
South Africa
   |   
Clinical Sites: 
BJGMC
PK, safety and acceptability data and practical guidance on the optimal dosing of new more child-friendly formulations of moxifloxacin and clofazimine in children are urgently needed to inform their current and future use in children with Rifampicin-Resistant TB (RR-TB). Both medications have a key...

Dynamics and immune mechanisms of QFT response in close contacts of TB cases

Post Date: 
2021-04-05
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
Rationale: A vaccine that prevents infection with Mycobacterium tuberculosis (Mtb) (POI vaccine) is an ideal approach to TB control. As Mtb infection (MTBI) is measured indirectly (positive tuberculin skin test (TST) or interferon gamma release assay (IGRA), prevention of IGRA conversion is the...

A Nanopore Biosensor for Leveling MTB Antigens in Blood

Post Date: 
2021-04-01
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
Purpose of the study: The inability to obtain diagnostically useful sputum specimens, or the inability to analyze non-sputum specimens, is a significant contributor to poor diagnostic sensitivity of current TB assays, leading to the WHO to call for the development of non-sputum-based biomarker or...

Pharmacokinetic Assessment of MDR-TB Drugs in the Treatment of TB Meningitis

Post Date: 
2020-08-23
   |   
Countries: 
China
India
South Africa
   |   
Clinical Sites: 
Hinduja Hospital
Rationale: MDR-TBM is a devastating disease with high mortality and severe neurologic sequelae among survivors. We recognize the importance of sufficient drug concentrations at the site of infection for efficacy of anti-TB drugs and believe it is likely that drug distribution into brain and CSF...

Identification of Biomarkers That Can Predict Progression from Latent Tuberculosis Infection to Active Tuberculosis Disease

Post Date: 
2020-08-23
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
NIRT
Purpose: The C-TRIUMPH study has identified 20 household contacts (HHC), who have progressed to active TB from its HHCs cohort (Cohort B). Immunological profiling of TB antigen induced biosignatures, profiling of transcriptional and proteomic biosignatures should provide novel insights into the...

Tuberculosis (TB) Aftermath

Post Date: 
2020-06-05
   |   
Countries: 
India
   |   
Clinical Sites: 
DY Patil
Drs. Vidya Mave and Jonathan Golub are co-PIs and Dr. Barthwal from DY Patil Medical College is local site PI for this study. TB Aftermath seeks to provide evidence for an effective and scalable strategy targeting HHs of treated TB cases, a high priority of the NTEP. Purpose To compare the...

Hybrid Trial for Alcohol Reduction among People with TB and HIV in India

Post Date: 
2020-02-12
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
DY Patil
Dr. Geetanjali Chander is PI and Dr. Kakrani is local site PI at DY Patil Medical College for this study. The highest incidence of tuberculosis disease (TB) in the world is in India, accounting for 27% of all new cases globally, with approximately 86,000 among persons with HIV (PWH). Unhealthy...

Pregnancy Associated Immune Responses to Tuberculosis and HIV in India and South Africa (PARTHISA)

Post Date: 
2020-01-14
   |   
Countries: 
India
South Africa
   |   
Clinical Sites: 
BJGMC
Dr. Jyoti Mathad is Co-PI of this study. Purpose: Tuberculosis (TB) is a leading cause of maternal mortality, especially among HIV-infected women. Women are most likely to develop active TB during and immediately after pregnancy. The immunologic conditions responsible for this phenomenon are not...

Increasing Market and Public Health Outcomes Through Scaling Up Affordable Access Models of Short Course Preventive Therapy for TB (IMPAACT4TB)

Post Date: 
2019-12-17
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
NIRT
Primary Objective: This study is being conducted in Brazil, Cambodia, China, Ethiopia, Ghana, Haiti, India, Indonesia, Kenya, Malawi, Mozambique, South Africa, Tanzania, and Zimbabwe. The overall goal is to reduce TB incidence among (1) people living with HIV who are on antiretroviral therapy, and...

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