: The Johns Hopkins University (JHU) is a national and international leader in HIV clinical research. The proposed JHU Baltimore-Washington-India (BWI) Clinical Trials Unit (CTU) will integrate three highly productive Clinical Research Sites at the JHU School of Medicine in Baltimore (JHU), Whitman Walker Health in Washington, DC (WWH), and the Byramji-Jeejeebhoy Government Medical College in Pune, India (BJMC). All three sites are currently affiliated with existing NIAID Networks, and with the Division of Infectious Diseases at the JHU School of Medicine, which will serve as the CTU home. These sites are in urban areas most greatly affected by the HIV epidemic, and include the largest HIV clinics in Baltimore and Washington, paired with India's second largest HIV clinic. Building on the existing relationships between these sites allows us to leverage complementary strengths. We expect this CTU to provide scientific leadership, access to important patient populations, and exemplary administrative integrity and cohesion. CTU Scientific Coordinating Committees will bring together expertise from these sites in our strongest fields: Tuberculosis, Hepatitis, HI Cure, HIV Prevention, Clinical Pharmacology, Pediatric &Adolescent Research, Inflammation &End-Organ Complications, Antibiotic Resistance, and Training &Mentorship. These Committees will serve as the creative focus for the CTU by developing new study proposals, identifying and prioritizing studies for site implementation, and encouraging young and international investigators to contribute to novel scientific concepts valued by the Networks we support. Our sites provide access to important and often under-represented populations for NIAID research, including impoverished urban African-Americans and other communities of color, those with a history of intravenous drug use and substance abuse, vulnerable sexually active adolescents and young adult urban MSM and women in Baltimore and Washington, as well as pregnant women, children, adolescents and adults in urban India. Integrating these three sites allows us to optimize the efficiency of our clinical research services with innovative management and communications, while better serving those affected by these epidemics.

Public Health Relevance

Research on HIV and related infections has improved the treatment and prevention of disease, but much more needs to be done to control the epidemic. The proposed Clinical Trials Unit will join together the most active HIV clinical research sites in Baltimore, Washington, DC, and Pune, India, to optimize patient-oriented research and to access key populations affected by this epidemic for participation in clinical trials.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
2UM1AI069465-08
Application #
8609766
Study Section
Special Emphasis Panel (ZAI1-DR-A (S3))
Program Officer
Bupp, Jane E
Project Start
2007-02-05
Project End
2020-11-30
Budget Start
2013-12-10
Budget End
2014-11-30
Support Year
8
Fiscal Year
2014
Total Cost
$2,098,394
Indirect Cost
$418,982
Name
Johns Hopkins University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21218
Haas, David W; Bradford, Yuki; Verma, Anurag et al. (2018) Brain neurotransmitter transporter/receptor genomics and efavirenz central nervous system adverse events. Pharmacogenet Genomics 28:179-187
Venuto, Charles S; Lim, Jihoon; Messing, Susan et al. (2018) Inflammation investigated as a source of pharmacokinetic variability of atazanavir in AIDS Clinical Trials Group protocol A5224s. Antivir Ther 23:345-351
MacBrayne, Christine E; Marks, Kristen M; Fierer, Daniel S et al. (2018) Effects of sofosbuvir-based hepatitis C treatment on the pharmacokinetics of tenofovir in HIV/HCV-coinfected individuals receiving tenofovir disoproxil fumarate. J Antimicrob Chemother 73:2112-2119
Shivakoti, Rupak; Gupte, Nikhil; Tripathy, Srikanth et al. (2018) Inflammation and micronutrient biomarkers predict clinical HIV treatment failure and incident active TB in HIV-infected adults: a case-control study. BMC Med 16:161
Nimkar, S; Valvi, C; Kadam, D et al. (2018) Loss to follow-up and mortality among HIV-infected adolescents receiving antiretroviral therapy in Pune, India. HIV Med 19:395-402
Li, Binglan; Verma, Shefali S; Veturi, Yogasudha C et al. (2018) Evaluation of PrediXcan for prioritizing GWAS associations and predicting gene expression. Pac Symp Biocomput 23:448-459
Riddler, Sharon A; Zheng, Lu; Durand, Christine M et al. (2018) Randomized Clinical Trial to Assess the Impact of the Broadly Neutralizing HIV-1 Monoclonal Antibody VRC01 on HIV-1 Persistence in Individuals on Effective ART. Open Forum Infect Dis 5:ofy242
Alfarisi, Omamah; Mave, Vidya; Gaikwad, Sanjay et al. (2018) Effect of Diabetes Mellitus on the Pharmacokinetics and Pharmacodynamics of Tuberculosis Treatment. Antimicrob Agents Chemother 62:
Shivakoti, Rupak; Ewald, Erin R; Gupte, Nikhil et al. (2018) Effect of baseline micronutrient and inflammation status on CD4 recovery post-cART initiation in the multinational PEARLS trial. Clin Nutr :
Ngongondo, McNeil; Miyahara, Sachiko; Hughes, Michael D et al. (2018) Hepatotoxicity During Isoniazid Preventive Therapy and Antiretroviral Therapy in People Living With HIV With Severe Immunosuppression: A Secondary Analysis of a Multi-Country Open-Label Randomized Controlled Clinical Trial. J Acquir Immune Defic Syndr 78:54-61

Showing the most recent 10 out of 123 publications