? The Indo-US collaborative research group, at the Byramjee Jeejeebhoy Medical College (BJMC) in Pune, India, is currently conducting the only NIH-sponsored; Phase III randomized clinical trial for prevention of mother-to-child HIV transmission (MTCT) in India. In response to this RFA, we propose a Clinical Trials Unit (CTU) with a single Clinical Research Site (CRS) that will build upon the success of our existing leadership, organization, clinical trials management procedures, as well as our experienced investigators and staff. Our CTU proposes to participate in trials that will address two research priority areas: 1) Prevention of MTCT and 2) Optimization of Clinical Management of HIV-infected Children. Johns Hopkins University (JHU) will be the primary grantee and will support the CTU leadership, administration, community activities and a single CRS in Pune, through two subcontracts (BJMC and ED SEARCH). BJMC will provide scientific and administrative leadership to the CTU, as well as clinical/laboratory infrastructure and clinical care support for the CRS. BJMC will also utilize the help of the National AIDS Research Institute for specialized laboratory support. ED SEARCH, a registered, Indian, non-profit Trust will provide scientific and administrative leadership, as well as day-to-day management of the CRS, regulatory requirements and good clinical practices. ED SEARCH will also manage support of our Community Advisory Board, as well as our trial recruitment program in 21 community-based clinics run by the Pune Municipal Corporation and the Pimpri Chinchwad Municipal Corporation. Our application reflects a fully-functional, experienced, actively-enrolling CTU that has more than three years of experience conducting the only Phase III HIV prevention clinical trial in India. We also have significant infrastructure, a proven GCP track record, and documented capacity for enrollment and retention of mothers and infants. Since August 2003, our CRS has provided HIV voluntary counseling and testing to more than 54,000 pregnant women in Pune. We have enrolled 593 HIV-infected mothers (20/month) in our current MTCT trial. Our capacity for pediatric treatment trials is supported by our active follow-up of 160 HIV-infected children and a supportive community-based referral program. The trajectory and impact of the global HIV epidemic is shifting to Asia and to India. Therefore, our CTU in Pune is uniquely positioned to contribute to the global efforts to prevent infant HIV infection and to optimize treatment of infected children. ? ? ADMINISTRATIVE COMPONENT: ? ?

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01AI069497-01
Application #
7096994
Study Section
Special Emphasis Panel (ZAI1-MH-A (M1))
Program Officer
Power, Maureen E
Project Start
2007-09-20
Project End
2014-01-31
Budget Start
2007-09-20
Budget End
2008-01-31
Support Year
1
Fiscal Year
2007
Total Cost
$100,000
Indirect Cost
Name
Johns Hopkins University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21218
Gupte, A N; Mave, V; Meshram, S et al. (2018) Trends in HbA1c levels and implications for diabetes screening in tuberculosis cases undergoing treatment in India. Int J Tuberc Lung Dis 22:800-806
Bharadwaj, Renu; Robinson, Matthew L; Balasubramanian, Usha et al. (2018) Drug-resistant Enterobacteriaceae colonization is associated with healthcare utilization and antimicrobial use among inpatients in Pune, India. BMC Infect Dis 18:504
Shaikh, N; Gupte, A; Dharmshale, S et al. (2017) Novel interferon-gamma assays for diagnosing tuberculosis in young children in India. Int J Tuberc Lung Dis 21:412-419
Bisson, Gregory P; Ramchandani, Ritesh; Miyahara, Sachiko et al. (2017) Risk factors for early mortality on antiretroviral therapy in advanced HIV-infected adults. AIDS 31:2217-2225
Tenforde, Mark W; Yadav, Ashish; Dowdy, David W et al. (2017) Vitamin A and D Deficiencies Associated With Incident Tuberculosis in HIV-Infected Patients Initiating Antiretroviral Therapy in Multinational Case-Cohort Study. J Acquir Immune Defic Syndr 75:e71-e79
Mave, Vidya; Nimkar, Smita; Prasad, Haridas et al. (2017) Tuberculosis screening among persons with diabetes mellitus in Pune, India. BMC Infect Dis 17:388
Mathad, Jyoti S; Gupta, Amita (2017) Pulmonary Infections in Pregnancy. Semin Respir Crit Care Med 38:174-184
Kinikar, Aarti; Gupte, Nikhil; Bhat, Jayalakshmi et al. (2017) Maternal Syphilis: An Independent Risk Factor for Mother to Infant Human Immunodeficiency Virus Transmission. Sex Transm Dis 44:371-375
Shivakoti, Rupak; Gupta, Amita; Ray, Jocelyn C et al. (2016) Soluble CD14: An Independent Biomarker for the Risk of Mother-to-Child Transmission of HIV in a Setting of Preexposure and Postexposure Antiretroviral Prophylaxis. J Infect Dis 213:762-5
La Rosa, Alberto M; Harrison, Linda J; Taiwo, Babafemi et al. (2016) Raltegravir in second-line antiretroviral therapy in resource-limited settings (SELECT): a randomised, phase 3, non-inferiority study. Lancet HIV 3:e247-58

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