(provided by the applicant): 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
Lennox, Jeffrey L; Landovitz, Raphael J; Ribaudo, Heather J et al. (2014) Efficacy and tolerability of 3 nonnucleoside reverse transcriptase inhibitor-sparing antiretroviral regimens for treatment-naive volunteers infected with HIV-1: a randomized, controlled equivalence trial. Ann Intern Med 161:461-71
Kuo, Irene; Golin, Carol E; Wang, Jing et al. (2014) Substance use patterns and factors associated with changes over time in a cohort of heterosexual women at risk for HIV acquisition in the United States. Drug Alcohol Depend 139:93-9
Leger, Paul D; Johnson, Daniel H; Robbins, Gregory K et al. (2014) Genome-wide association study of peripheral neuropathy with D-drug-containing regimens in AIDS Clinical Trials Group protocol 384. J Neurovirol 20:304-8
Haley, Danielle F; Golin, Carol; El-Sadr, Wafaa et al. (2014) Venue-based recruitment of women at elevated risk for HIV: an HIV Prevention Trials Network study. J Womens Health (Larchmt) 23:541-51
Haley, Danielle F; Lucas, Jonathan; Golin, Carol E et al. (2014) Retention strategies and factors associated with missed visits among low income women at increased risk of HIV acquisition in the US (HPTN 064). AIDS Patient Care STDS 28:206-17
Adimora, Adaora A; Hughes, James P; Wang, Jing et al. (2014) Characteristics of multiple and concurrent partnerships among women at high risk for HIV infection. J Acquir Immune Defic Syndr 65:99-106
Johnson, Daniel H; Venuto, Charles; Ritchie, Marylyn D et al. (2014) Genomewide association study of atazanavir pharmacokinetics and hyperbilirubinemia in AIDS Clinical Trials Group protocol A5202. Pharmacogenet Genomics 24:195-203
Sulkowski, Mark S; Kang, Minhee; Matining, Roy et al. (2014) Safety and antiviral activity of the HCV entry inhibitor ITX5061 in treatment-naive HCV-infected adults: a randomized, double-blind, phase 1b study. J Infect Dis 209:658-67
Gupta, Amita; Mathad, Jyoti S; Yang, Wei-Teng et al. (2014) Maternal pneumococcal capsular IgG antibodies and transplacental transfer are low in South Asian HIV-infected mother-infant pairs. Vaccine 32:1466-72
Hodder, Sally L; Justman, Jessica; Hughes, James P et al. (2013) HIV acquisition among women from selected areas of the United States: a cohort study. Ann Intern Med 158:10-8

Showing the most recent 10 out of 12 publications