Clinical Research

Clinical Sites:

There have been tremendous advances in the diagnosis of patients with tuberculosis (TB) based on nucleic acid amplification of bacteria in the sputum. The GenXpert MTB/RIF provides results in 2 hours. However, in HIV-infected sputum smear is often negative for AFB and the sensitivity of GenXpert...

Antimicrobial Use and Diagnosis among Hospitalized Febrile Patients in Pune, India

Post Date:

2017-08-07

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Antimicrobial resistance, a leading threat to human health, is enabled by unnecessary antibiotic use. Strategies to reduce unnecessary antibiotic use in India, the world’s largest antibiotic consumer, are urgently needed. Although most patients hospitalized in India with acute febrile illness...

Association of Lipid Mediators of Inflammation with TB Treatment Outcomes

Post Date:

2017-08-03

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This study was terminated July 22, 2019. This study used stored samples from 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. Recent studies...

Role of Specialized Pro-resolving Mediators (SPMs) on Markers of Inflammation in HIV-infected Adults

Post Date:

2017-08-03

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Dr. Rupak Shivikoti is leading this study. There has been a surge of recent studies focusing on the role of novel lipid mediators of inflammation called specialized pro-resolving mediators (SPMs). They are produced during inflammation as a negative feedback to resolve inflammation. However, the...

Optimizing Treatment to Improve TBM Outcomes in Children: Substudy on Clinical Profile and CSF Biorepository of the Pediatric Suspected Meningitis Cases

Post Date:

2017-07-18

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This sub-study is being led by PIs Dr. Kelly Dooley and Dr. Chhaya Valvi. Meningoencephalitis is associated with significant morbidity and mortality. Several viruses, bacteria, and fungal pathogens including Neisseria meningitidis, Streptococcus pneumoniae, Mycobacterium tuberculosis, Herpes...

A5332: Randomized Trial to Prevent Vascular Events in HIV – REPRIEVE

Post Date:

2017-06-09

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This study is conducted under the AIDS Clinical Trials Group (ACTG) and funded by the U.S. National Institutes of Health. This is a prospective, double-blind, randomized, placebo-controlled, multicenter efficacy study in 6500 subjects, with individual subjects to be followed for up to 72 months...

A5349: Rifapentine-containing Treatment Shortening Regimens for Pulmonary Tuberculosis: A Randomized, Open-label, Controlled Phase 3 Clinical Trial

Post Date:

2017-06-05

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This study is conducted under the AIDS Clinical Trials Group (ACTG) and funded by the U.S. National Institutes of Health. This is an international, multicenter, randomized, controlled, open-label, 3-arm, phase 3 non-inferiority trial. Primary Objectives: To evaluate the efficacy of a rifapentine-...

Understanding Quality of Life during and Loss to Follow-up from Drug-Resistant Tuberculosis Treatment in Pune, India

Post Date:

2017-05-15

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This study will examine a) risk factors for loss to follow-up from DR-TB treatment, b) actively trace DR-TB patients lost to follow-up from treatment and c) establish a prospective observational cohort of MDR-TB, XDR-TB and DS-TB patients as well as healthy controls nested within ongoing RNTCP...

Risk Factors for Unfavourable Treatment Outcomes among Multidrug-Resistant Tuberculosis Patients in Public Sector Treatment in Pune

Post Date:

2017-03-29

Countries:

This study is funded and conducted under the U.S. National Institutes of Health, Fogarty International Center. This study seeks to identify risk factors associated with unfavourable treatment outcomes (death, treatment failure, default, XDR-TB) among multidrug-resistant tuberculosis (MDR-TB)...

MDR-TB Free: Monitoring Adverse Effects, Utilizing Resources Optimally, Knowing Resistance Patterns, and Treatment Strategy

Post Date:

2017-03-24

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This study is also known as MDR-TB MUKT: M onitoring Adverse Effects, U tilizing Resources Optimally, K nowing Resistance Patterns, and T reatment Strategy. Purpose: To establish an observational cohort of MDR-TB cases and household contacts with accompanying biorepository at PD Hinduja National...

Biomarkers for Tuberculosis Diagnosis and Treatment Response

Post Date:

2017-03-24

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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. Aims: To develop non-sputum, blood-based tools for TB diagnosis and...

Impact of HIV and Diabetes Mellitus on TB Drug Resistance and Recurrence

Post Date:

2017-03-02

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Tuberculosis (TB) is the leading cause of mortality globally. With increasing burden of HIV and diabetes mellitus (DM), there is a critical need to understand the microbial response and ensuing disease dynamics of TB in the HIV-infected and diabetic host to optimally control TB globally. Among...

Multicenter Study of the Accuracy of the BD MAX MDR-TB Assay for Detection of M. tuberculosis Complex and Mutations Associated with Resistance to Rifampin or Isoniazid

Post Date:

2017-03-01

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In a multi-country study, we are assessing the accuracy of the BD MAX rapid MDR-TB assay to detect rifampin and isoniazid resistance.

TREAT Asia Pediatric HIV Observational Database

Post Date:

2017-02-09

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Studies conducted under the TREAT Asia Network and funded by amfAR. TREAT Asia Pediatric HIV Observational Database (TApHOD) is a collaborative observational cohort study of infants, children, and adolescents living with HIV. TApHOD study participants are enrolled and followed at selected TREAT...

TREAT Asia Observational Database

Post Date:

2017-02-09

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Study conducted under the TREAT Asia Network and funded by amfAR. The TREAT Asia Observational Database's primary study objective is to: Examine HIV natural history, including the relationship between access to ART, demographics, and disease progression; short- and long-term responses to ART;...

Shorter Treatment for Minimal TB in Children (SHINE)

Post Date:

2017-01-17

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This is a multicountry study being conducted in India, South Africa, Uganda, and Zambia. The principal objective is to determine whether the standard 6 month regimen (8 weeks HRZ(E) followed by 16 weeks HR) can be reduced with similar efficacy, to 4 months (8 weeks HRZ(E) followed by 8 weeks HR),...

Healthcare-Associated Sepsis in the Neonatal Intensive Care Unit in Pune, India

Post Date:

2017-01-17

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This study is part of CDC's Safe Healthcare, Epidemiology, and Prevention Research Development (SHEPheRD) Program under Domain 7: International HAI and Other Adverse Healthcare Event Prevention. Johns Hopkins neonatologist Dr. Julia Johnson is lead investigator for a systematic study of the...

Bacterial Antimicrobial Resistance Patterns in Pune, India: Substudy on the Introduction of Triage to a Triage Naïve Emergency Department in Pune, India, and the Effects on Patient Flow

Post Date:

2017-01-01

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Despite state-of-the-art inpatient facilities, Sassoon General Hospital (SGH) in Pune, India, does not currently have a method of triaging the large volume of patients they care for on a daily basis. Based on prior studies in low to middle income countries with underdeveloped emergency medical...

LaMocha: A Mobile Technology to Promote HIV Testing among Immigrant Latino Men

Post Date:

2016-12-15

Countries:

Foreign-born Latino males have a high risk of late HIV diagnosis and presentation to care, which can lead to poor clinical outcomes and ongoing HIV transmission in the community. We propose to evaluate if tailored videos delivered through a tablet by a Latino Health Worker and regular SMS text...

Prevalence and Risk Factors for Oral Cancer among HIV-Infected Adults

Post Date:

2016-12-13

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The study is designed as a cross-sectional, single time point study for opportunistic oral cancer screening of HIV-infected and non- HIV adults 21 years or older in an urban hospital. All participants will undergo screening for oral cancer and oral potentially malignant disorders (OPMD) by visual...

The role of perceived friend depression and perceived stigma on self-reported depression among individuals who use drugs

Post Date:

2018-11-15

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Publication:

Journal of Community Psychology

Depression and substance use are highly comorbid, and stigmatized, mental health conditions influenced by social network factors. The objective of this study was to explore the role of perceived depression and perceived mental health stigma among friends on self-reported depression over time...

Missed opportunities to address pregnancy prevention with young men in primary care

Post Date:

2018-11-15

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Clinical Pediatrics

Young men (aged 15-24 years) have pregnancy prevention needs, yet little is known about whether they perceive they learn about pregnancy prevention in primary care. A sample of 190 young men seen in primary care in one city from April 2014 to September 2016 were assessed on perceived learning about...

The global landscape of tuberculosis therapeutics

Post Date:

2018-11-07

Publication:

Annual Review of Medicine

Abstract Tuberculosis (TB) is one of the oldest infections afflicting humans yet remains the number one infectious disease killer worldwide. Despite decades of experience treating this disease, TB regimens require months of multidrug therapy, even for latent infections. There have been important...

Economic and epidemiologic impact of guidelines for early ART initiation irrespective of CD4 count in Spain

Post Date:

2018-11-05

Countries:

Spain

Publication:

PLoS One

INTRODUCTION: Emerging data suggest that early antiretroviral therapy (ART) could reduce serious AIDS and non-AIDS events and deaths but could also increase costs. In January 2016, the Spanish guidelines were updated to recommend ART at any CD4 count. However, the epidemiologic and economic impacts...

Centro SOL: A community-academic partnership to care for undocumented immigrants in an emerging Latino area

Post Date:

2018-10-30

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Academic Medicine

PROBLEM: From 2000 to 2014, the Latino population in Baltimore city, an emerging Latino settlement area, has experienced rapid growth. Many of these individuals are undocumented and not eligible for coverage. Academic medical centers often lead the way in addressing the health needs of undocumented...

Results of early virologic monitoring may facilitate differentiated care monitoring strategies for clients on ART, Rakai, Uganda

Post Date:

2018-10-15

Countries:

Uganda

Publication:

Open Forum Infectious Diseases

BACKGROUND: Viral load (VL) monitoring is standard of care in HIV-infected persons initiated on antiretroviral therapy (ART). We evaluated the predictive value of VL measurements at 6 and 12 months after initiation of firstline ART to estimate the future risk of virologic failure (VF). METHODS: HIV...

Enhanced immigration enforcement in the USA and the transnational continuity of HIV care for Latinx migrants in deportation proceedings

Post Date:

2018-10-15

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Lancet HIV

In our work as clinicians, researchers, and immigrant rights advocates, we have noted increased anxiety about the possibility of deportation and disruptions in care among immigrants with HIV. Before the 2016 US elections, patients rarely asked about HIV treatment in their home countries. However,...

Drug-resistant Enterobacteriaceae colonization is associated with healthcare utilization and antimicrobial use among inpatients in Pune, India

Post Date:

2018-10-04

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Publication:

BMC Infectious Diseases

BACKGROUND: Healthcare exposure may increase drug-resistant Enterobacteriaceae colonization risk. Nascent antimicrobial stewardship efforts in low- and middle-income countries require setting-specific data. We aimed to evaluate risk factors for inpatient drug resistant Enterobacteriaceae...

Barriers to screening and isoniazid preventive therapy for child contacts of tuberculosis patients

Post Date:

2018-10-01

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Publication:

International Journal of Tuberculosis and Lung Disease

Universal, timely TB screening and IPT for exposed children are urgently needed to reduce pediatric TB in India

Inflammation and micronutrient biomarkers predict clinical HIV treatment failure and incident active TB in HIV-infected adults: a case-control study

Post Date:

2018-09-24

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Publication:

BMC Medicine

Factors identified through exploratory factor analysis were associated with adverse outcomes in HIV-infected individuals.

Report of the Technical Consultation on Advances in Clinical Trial Design for Development of New TB Treatments

Post Date:

2018-09-17

Publication:

WHO Task Force on Introduction of New TB Drugs and Treatment Regimens

Dr. Amita Gupta was a member of this TB technical consultation, convened in March 2018 in Switzerland.

Ovarian mass - tuberculosis or malignancy? Need for early intensified evaluation

Post Date:

2018-09-14

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Publication:

EXCLI Journal

Letter to the Editor Dear Editor, We read with interest the case report by Chien et al. on Peritoneal Tuberculosis (TB) mimicking ovarian cancer (Chien et al., 2016[1]). We want to congratulate the authors on this case report. We encountered a similar case in our clinical setting in western India...

The association of household fine particulate matter and kerosene with tuberculosis in women and children in Pune, India

Post Date:

2018-09-07

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Publication:

Occupational and Environmental Medicine

Use of kerosene cooking fuel is positively associated with TB in women and children in our analysis using reported sources of exposure.

Challenges and opportunities for outreach workers in the Prevention of Mother to Child Transmission of HIV (PMTCT) program in India

Post Date:

2018-09-04

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Publication:

PLoS One

PLoS One: Prevention of Mother-to-Child Transmission of HIV program in India is one of the largest in the world, and it relies on outreach workers. Our study looked at challenges and opportunities for outreach workers.

Failure in TB control: why should the rapid diagnostic test bear the blame?

Post Date:

2018-09-01

Publication:

International Journal of Tuberculosis and Lung Disease

Dr. Sachit Atre's correspondence published in the International Journal of Tuberculosis and Lung Disease.

Resource utilization for multidrug-resistant tuberculosis household contact investigations (A5300/I2003)

Post Date:

2018-09-01

Clinical Sites:

Publication:

International Journal of Tuberculosis and Lung Disease

Current guidelines recommend evaluation of the household contacts of individuals with multidrug-resistant tuberculosis; however, implementation of this policy is challenging.

Syndemic factors and resiliency among Latina immigrant indirect sex workers in an emergent immigrant city

Post Date:

2018-08-23

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Publication:

Journal of Immigrant and Minority Health

Female sex workers (FSW) constitute a highly vulnerable population challenged by numerous co-existing, or syndemic, risk factors. FSW also display resilience to these, and some evidence suggests that resilience may be associated with protective factors that improve health outcomes. We conducted in-...

The effect of diabetes mellitus on the pharmacokinetics and pharmacodynamics of tuberculosis treatment

Post Date:

2018-08-20

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Publication:

Antimicrobial Agents and Chemotherapy

DM and higher HbA1c increased the risk of not achieving therapeutic targets for pyrazinamide, but higher pyrazinamide concentrations were asociated with worse microbiologic and clinical outcomes

Antimicrobial susceptibility of Neisseria gonorrhoeae isolates in Baltimore, Maryland – 2016: The importance of sentinel surveillance in the era of multi-drug resistant gonorrhea

Post Date:

2018-08-17

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Publication:

Antibiotics

The increasing rates of gonorrhea infections and the global emergence and spread of multi-drug-resistant Neisseria gonorrhoeae (NG) threaten the successful management of gonorrhea. In the era of nucleic acid amplification tests (NAATs), surveillance projects are urgently needed to monitor...

Identifying solutions to improve the sexually transmitted infections testing experience for youth through participatory ideation

Post Date:

2018-08-15

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Publication:

AIDS Patient Care and STDs

Sexually transmitted infection (STI) services, including screening, treatment, and counseling among youth, remain suboptimal. In the midst of increasing incidence of bacterial STIs, alarming STI disparities, and persistently low testing rates among youth, solution-focused and action-oriented...

The ACTG IMPAACT PHOENIx Feasibility Study: Implications for Country Programs

Post Date:

2017-10-13

Clinical Sites:

Gupta A. The ACTG IMPAACT PHOENIx Feasibility Study: Implications for Country Programs. 48th Annual Union World Conference of Lung Health. Guadalajara, Mexico.

Delays and Barriers to Early Treatment Initiation for Childhood Tuberculosis in India

Post Date:

2017-10-13

Clinical Sites:

Valvi C , Chandanwale A, Khadse A, Kulkarni R, Kadam D, Dhumal G, Bollinger RC, Deluca A. Delays and Barriers to Early Treatment Initiation for Childhood Tuberculosis in India. 48th Annual Union World Conference of Lung Health. Guadalajara, Mexico. October 13, 2017.

Accessing MDR-TB Exposed Households: the PHOENiX MDR-TB Feasibility Study

Post Date:

2017-10-13

Clinical Sites:

Gupta A. Accessing MDR-TB Exposed Households: the PHOENiX MDR-TB Feasibility Study. 48th Annual Union World Conference of Lung Health. Guadalajara, Mexico.

Biological Differences in Tuberculosis Diagnosis and Disease in Women

Post Date:

2017-10-12

Clinical Sites:

Mathad J. Biological Differences in Tuberculosis Diagnosis and Disease in Women. 48th Annual Union World Conference of Lung Health. Guadalajara, Mexico.

Symposium: From Bench to Bassinet: Scientific Innovations: The Fight against Maternal-Infant TB

Post Date:

2017-10-12

Clinical Sites:

Gupta A. Symposium: From Bench to Bassinet: Scientific Innovations: The Fight against Maternal-Infant TB. 48th Annual Union World Conference of Lung Health. Guadalajara, Mexico.

Barriers to Contact Screening and Isoniazid Preventive Therapy among Pediatric Contacts of Adults with Smear-positive Tuberculosis

Post Date:

2017-10-12

Clinical Sites:

Belgaumkar V , Chandanwale A, Valvi C, Khadse S, Jain D, Dhumal G, Bollinger RC, Deluca A. Barriers to Contact Screening and Isoniazid Preventive Therapy among Pediatric Contacts of Adults with Smear-positive Tuberculosis. 48th Annual Union World Conference of Lung Health. Guadalajara, Mexico.

Drug Susceptibility of Rifampin-resistant Tuberculosis using Whole Genome Sequencing to Identify Genes of Interest in Pune, India

Post Date:

2017-10-12

Clinical Sites:

Tornheim JA , Madugundu AK, Pradhan N, Bharadwaj R, Mave V, Golub J, Pandey A, Gupta A. Drug Susceptibility of Rifampin-resistant Tuberculosis using Whole Genome Sequencing to Identify Genes of Interest in Pune, India. 48th Annual Union World Conference of Lung Health. Guadalajara, Mexico.

Trends in Glycated Hemoglobin Levels and Implications for Diabetes Screening among Pulmonary Tuberculosis Cases Undergoing Treatment in India

Post Date:

2017-09-13

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Clinical Sites:

DY Patil

Gupte AN , Mave V, Meshram S, Lokhande R, Kadam D, Dharmshale S, Bharadwaj R, Kagal A, Pradhan N, Deshmukh S, Atre S, Sahasrabudhe T, Barthwal M, Meshram S, Kakrani A, Kulkarni V, Raskar S, Suryavanshi S, Shivakoti R, Chon S, Selvin E, Gupte N, Gupta A, Golub JE. Trends in Glycated Hemoglobin...

High Burden of Diabetes and Prediabetes among Adult Household Contacts of India

Post Date:

2017-09-13

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Clinical Sites:

Shivakumar SVBY , Chandrasekaran P, Kumar AJMV, Paradkar M, Dhanasekaran K, Suryavanshi N, Thomas B, Kohli R, Thiruvengadam K, Kulkarni V, Hannah LE, Sivaramakrishnan GN, Pradhan N, Dolla C, Gupte A, Ramachandran G, DeLuca A, Meshram S, Bhardawaj R, Bollinger RC, Golub J, Selvaraj K, Gupte N,...

Gene Expression Profiles of Pediatric Tuberculosis Patients and Exposed Controls from India

Post Date:

2017-09-13

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Clinical Sites:

Tornheim JA , Paradkar M, Madugundu A, Gupte N, Kulkarni V, Sreenivasamurthy S, Raja R, Pradhan N, Shivakumar SVBY, Valvi C, Kohli R, Chandrasekaran P, Mave V, Pandey A, Gupta A. Gene Expression Profiles of Pediatric Tuberculosis Patients and Exposed Controls from India. RePORT International...

Linezolid Experience among MDRTB Patients in Mumbai

Post Date:

2017-09-13

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Clinical Sites:

Tornheim J, Ganatra S, Deluca A, Banka R, Rodrigues C, Gupta A, Udwadia Z. Poster Presentation. Linezolid Experience among MDRTB Patients in Mumbai. ERS International Congress. European Respiratory Society. Milan, Italy.

Hepatotoxicity in HIV+ Postpartum Women Initiating Efavirenz-Containing Regimens

Post Date:

2017-07-26

Countries:

Bhattacharya D , Gupta A, Tierney C, Huang S, Peters M, Chipato T, Martinson F, Dula D, George K, Chaktoura N, Klingman K, Gnanashanmugam D, Currier J, Fowler MG. Hepatotoxicity in HIV+ Postpartum Women Initiating Efavirenz-Containing Regimens. IAS 2017. International AIDS Society. Paris, France...

Hepatotoxicity in HIV+ Postpartum Women Initiating Efavirenz-Containing Regimens in PROMISE P1077

Post Date:

2017-05-31

Amita Gupta. Hepatotoxicity in HIV+ Postpartum Women Initiating Efavirenz-Containing Regimens in PROMISE P1077. 2017 IMPAACT Annual Meeting. Washington, DC. 2017

A5300B/IMPAACT 2003B – PHOENix MDR TB: Protecting Households on Exposure to Newly Diagnosed Index Multidrug-Resistant TB Patients

Post Date:

2017-05-30

Gupta, A. A5300B/IMPAACT 2003B – PHOENix MDR TB: Protecting Households on Exposure to Newly Diagnosed Index Multidrug-Resistant TB Patients. 2017 IMPAACT Annual Meeting. Washington, DC.

A5300/I2003/PHOENIx Trial Update

Post Date:

2017-05-30

Gupta, A. A5300/I2003/PHOENIx Trial Update. 2017 IMPAACT Annual Meeting. Washington, DC. 2017.

IMPAACT 2001: Trial of the Pharmacokinetics, Tolerability, and Safety of Once-Weekly Rifapentine and Isoniazid in HIV-infected and HIV-1-uninfected Pregnant and Postpartum Women with Latent Tuberculosis Infection

Post Date:

2017-05-30

Jyoti Mathad. IMPAACT 2001: Trial of the Pharmacokinetics, Tolerability, and Safety of Once-Weekly Rifapentine and Isoniazid in HIV-infected and HIV-1-uninfected Pregnant and Postpartum Women with Latent Tuberculosis Infection. 2017 IMPAACT Annual Meeting. Washington, DC. 2017.

CTRIUMPh Pediatric Biomarker Substudy

Post Date:

2017-05-30

Countries:

Clinical Sites:

Tornheim J . Paradkar M. CTRIUMPh Pediatric Biomarker Substudy. 2017 IMPAACT Annual Meeting. Washington, DC. 2017.

A5300/I2003/PHOENIx Preparatory Study of MDR TB Cases and Their Household Contacts: Operational Feasibility to Inform PHOENIx Trial

Post Date:

2017-05-29

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Clinical Sites:

Gupta, A. A5300/I2003/PHOENIx Preparatory Study of MDR TB Cases and Their Household Contacts: Operational Feasibility to Inform PHOENIx Trial. 2017 IMPAACT Annual Meeting. Washington, DC. 2017.

How Americans Benefit from Global Health Research

Post Date:

2017-05-25

Countries:

Bollinger, R. How Americans Benefit from Global Health Research. The Fogarty International Center: How Americans Benefit from Global Health Research Webinar, Research!America. Washington, DC.

Knowledge, Attitudes and Practices About Multidrug-Resistant Tuberculosis (MDR-TB) and Preventive Therapy Among Adult and Adolescent Household Contacts of MDR-TB Index Cases

Post Date:

2017-05-22

Countries:

Clinical Sites: