Smita Nimkar, MSc

Pune, India
Role: 
Staff
Regulatory Coordinator
Smita Nimkar, MSc

Smita Nimkar is Regulatory Coordinator and IRB/EC Liaison for the clinical research site (CRS) at BJ Government Medical College (BJGMC) in Pune, India. The BJGMC CRS is part of the Baltimore-Washington-India Clinical Trials Unit (BWI-CTU)—which conducts clinical trials under the NIH ACTG and IMPAACT Trial Networks—along with the Johns Hopkins CRS (Baltimore, MD) and the Whitman Walker Health CRS (Washington, DC). She works with the India research team to ensure training on and compliance with scientific regulatory standards at all levels, assists with all submissions to IRBs including new protocols, progress reports, amendments, reviews, adverse event reports, and other assurance requirements. She is Vice Chair of the ACTG -Site Management Clinical Care Committee (SMCCC), ex member of IMPAACT Training and Education Committee, Life Member of the Forum for Ethics Review Committees in India, and member of Public Responsibility in Research (PRIM&R). Smita has worked in healthcare for more than 20 years, and her experience includes HIV/AIDS work, and clinical pathology, clinical research, contract research, and integrated research (Modern and Traditional) to develop new drugs and formulations from medicinal plants, She also has coordinated several research projects on communicable and non-communicable diseases. She is currently pursuing a PhD in health sciences.

Impact of Diabetes on TB Treatment Outcomes: Nested Study: Lipid Mediators of Inflammation in TB and TB-Diabetes

Post Date: 
2017-10-02
Studies have shown that individuals with Tuberculosis (TB) and diabetes (TB-DM) have a distinct immune profile compared to individuals with TB alone. Individuals with TB-DM have higher inflammation, a higher bacillary load, increased Th1 immune responses and a defective neutrophil and macrophage...

RePORT: C-TRIUMPH: Nested Study on Targeting Mycobacterium Tuberculosis Persisters by Enhancing Stringent Response-specific Cellular Immunity

Post Date: 
2017-09-11
Country: 
C-TRIUMPH nested study begins to see if stringent response antigen is enhanced while treating drug-susceptible TB using the first-line anti-TB regimen.

Zika Surveillance among Antenatal Clinic Outpatients in BJ Government Medical College and Sassoon General Hospitals, Pune, India

Post Date: 
2017-08-31
Country: 
CCGHE is keeping an eye on Zika among pregnant women, which is transmitted by mosquitoes & can cause devastating birth defects.

TREAT Asia: Pediatric HIV Observational Database

Post Date: 
2017-02-09
Country: 
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 Asia Network clinical sites in the Asia-Pacific region. Participating...

TREAT Asia Observational Database

Post Date: 
2017-02-09
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; impact of co-infections; HIV drug resistance patterns; and toxicity of...

Optimizing Treatment to Improve TBM Outcomes in Children

Post Date: 
2014-05-01
Country: 
This study 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 levofloxacin in children ages 6 months to 12 years of age with TBM To assess the...

BWI CTU: Baltimore-Washington-India Clinical Trials Unit

Post Date: 
2007-02-02
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...

Isoniazid hair concentrations in children with tuberculosis: a proof of concept study

Post Date: 
2016-06-01
Publication: 
International Journal of Tuberculosis and Lung Disease
Country: 
Assessing treatment adherence and quantifying exposure to anti-tuberculosis drugs among children is challenging. We undertook a 'proof of concept' study to assess the drug concentrations of isoniazid (INH) in hair as a therapeutic drug monitoring tool. Children aged <12 years initiated on a...

Attrition among HIV-infected Adolescent Girls and Young Women in Pune, India

Post Date: 
2016-12-06
Presentation Location: 
Birmingham, AL
Country: 
Event & Convener: 
Center for AIDS Research. Women and HIV: Inter-CFAR Joint Symposium on HIV Research in Women
Poster presentation. Nimkar S , Kadam D, Marbaniang I, Suman R, Gupte N, Salvi S, Suryavanshi N, Gupta A, Mave V.

Characteristics of HIV-infected Transgender Women Registered under Programmatic Conditions in Pune, India

Post Date: 
2016-12-06
Presentation Location: 
Birmingham, AL
Country: 
Event & Convener: 
Center for AIDS Research. Women and HIV: Inter-CFAR Joint Symposium on HIV Research in Women
Oral presentation. Marbaniang I , Kadam D, Gupte N, Suman R, Salvi S, Nimkar S, Suryavanshi N, Gupta A, Mave V.

Spousal Serostatus Affects Retention in Care among Married HIV Infected Women in Pune, India

Post Date: 
2016-12-06
Presentation Location: 
Birmingham, AL
Country: 
Event & Convener: 
Center for AIDS Research. Women and HIV: Inter-CFAR Joint Symposium on HIV Research in Women
Poster presentation. Nimkar S , Kadam D, Marbaniang I< Suman R, Gupte N, Salvi S, Suryavanshi N, Gupta A, Mave V.

High Risk for Loss to Follow-Up among Adolescents Living with HIV in Pune, India

Post Date: 
2016-07-19
Presentation Location: 
Durban, South Africa
Country: 
Event & Convener: 
21st International AIDS Conference. International AIDS Society.
Presentation. Nimkar S , Valvi C, Khadse S, Kadam D, Kinikar A, Marbaniang I, Rewari BB, Chandanwale A, Suryavanshi N, Patil S, Nevrekar N, Raichur P, Gupta A, Mave V

Isoniazid Hair Concentrations in Children with TB

Post Date: 
2015-12-05
Presentation Location: 
Cape Town, South Africa
Country: 
Event & Convener: 
46th Union World Conference on Lung Health. International Union for Tuberculosis and Lung Disease.
Poster Session. Authors: Mave V, Kinikar AA, Gupte N, Nimkar S, Kagal A, Horng H, Ramachandran G, Dooley K, Gupta A.