Rosemarie Warlick

Role:

Staff

Regulatory Affairs Coordinator

Ms. Warlick is the Regulatory Affairs Coordinator for the Indo-JHU clinical trials unit and has worked for the University for more than 30 years. She works closely with the US study team and international study personnel to assure compliance with institutional, local and national regulatory standards. She provides regulatory support for new and ongoing research studies, assisting with all IRB submissions including new submissions, continuing reviews, progress reports, protocol amendments, adverse events, violations/deviations, and ensures all required occurrences are reported and reviewed in a timely manner. In between regulatory duties, Ms. Warlick assists with grant preparation, possessing valuable knowledge and understanding of the grant submission and award process between JHU and various funding agencies.

Studies/Projects

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...

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...

A Randomized Therapeutic Interventional Comparative Study between Three Different Modalities of Paediatric Antitubercular Treatment

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2016-06-13

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This study was terminated July 6, 2019. It was funded by the Fogarty International Center at the U.S. National Institutes of Health. This study evaluated three different TB treatment regimens in children attending Sassoon General Hospital in Pune, India. A...

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

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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...

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

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2014-06-16

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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...

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

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2014-03-26

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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...

Epidemiological Assessment of Pediatric Tuberculosis in Pune, India, through Contact Tracing

Post Date:

2013-06-10

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This study ended in June 2016. Approximately 1 million new cases of Tuberculosis occur among children each year around the world, with a large number of these cases occurring among indigent populations without access to adequate healthcare facilities (World Health Organization). Due to their high...

Impact Evaluation of Tobacco Cessation Intervention for Tuberculosis patients under Revised National Tuberculosis Control Programme in Rural and Urban areas at Vadodara, Gujarat, INDIA

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2011-12-09

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TBA

Understanding Challenges and Perspectives of Parents about HIV Disclosures to their Children and Develop a Structured HIV Disclosure Model for Pediatric Age Group

Post Date:

2011-12-08

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This study is terminated. In 2008 an estimated 70,000 children in India were living with HIV, with 21,000 new children are infected each year through mother to child transmission (Singh et al 2008). Increasing availability of antiretroviral treatment (ART) to HIV infected children in India means...

Predictors of Perinatal HBV Transmission in an HIV/HBV Infected Cohort

Post Date:

2011-04-22

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This study ended in 2014. Hepatitis B virus (HBV) coinfection is common; affecting greater than 10% of HIV-infected individuals in resource-limited settings(1-3). Although the impact of HIV disease on HBV coinfection has been studied in non-pregnant adults, little is known...

Assessment of Active Tuberculosis amongst Asymptomatic HIV-infected Patients in Kakinada, India

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2009-07-23

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This study was conducted in 2008. Tuberculosis (TB) is a major public health threat in India and is the leading cause of morbidity and mortality amongst people living with HIV/AIDS worldwide.1 According to the WHO, India accounts for one-fifth of the global TB incident cases...

A5253: Sensitivity and Specificity of Mycobacterium Tuberculosis Screening and Diagnostics in HIV-Infected Individuals

Post Date:

2009-03-19

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This study was terminated October 15, 2014. An estimated 3 million HIV-infected individuals will enter programs for antiretroviral (ARV) treatment in the coming year, with projected rates of requirement for ARV therapy extending to more than 10 million in sub-Saharan Africa...

The Association of Umbilical Cord Blood IgG Streptococcus pneumoniae and Hemophilus influenzae Antibody Titers with Mortality and Morbidity among HIV-exposed Infants in India

Post Date:

2007-08-30

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This study ended in August 2010. In India, HIV-exposed infants (infants born to HIV-infected mothers), bear a large burden of mortality and morbidity from S. pneumoniae and H. influenzae type b infections. These bacterial respiratory pathogens are responsible for the majority of mortality and...

BWI CTU: Baltimore-Washington-India Clinical Trials Unit

Post Date:

2007-02-02

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Comprising clinical trial sites at Johns Hopkins Medicine in Baltimore, Whitman Walker Health in Washington, DC, and the BJGMC-CCGHE collaboration in Pune, India, the Baltimore-Washington-India Clinical Trials Unit (BWI-CTU) is one of only 25 international HIV/TB clinical trial sites funded by the...

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

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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...