(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)
Type
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
5UM1AI069465-11
Application #
9181370
Study Section
Special Emphasis Panel (ZAI1)
Program Officer
Bupp, Jane E
Project Start
Project End
Budget Start
Budget End
Support Year
11
Fiscal Year
2017
Total Cost
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
21205
Hendrix, Craig W; Andrade, Adriana; Bumpus, Namandjé N et al. (2016) Dose Frequency Ranging Pharmacokinetic Study of Tenofovir-Emtricitabine After Directly Observed Dosing in Healthy Volunteers to Establish Adherence Benchmarks (HPTN 066). AIDS Res Hum Retroviruses 32:32-43
Shivakoti, Rupak; Christian, Parul; Yang, Wei-Teng et al. (2016) Prevalence and risk factors of micronutrient deficiencies pre- and post-antiretroviral therapy (ART) among a diverse multicountry cohort of HIV-infected adults. Clin Nutr 35:183-9
Landovitz, Raphael J; Tran, Thuy Tien T; Cohn, Susan E et al. (2016) HIV Transmission Risk Behavior in a Cohort of HIV-Infected Treatment-Naïve Men and Women in the United States. AIDS Behav 20:2983-2995
Shivakoti, Rupak; Yang, Wei-Teng; Berendes, Sima et al. (2016) Persistently Elevated C-Reactive Protein Level in the First Year of Antiretroviral Therapy, Despite Virologic Suppression, Is Associated With HIV Disease Progression in Resource-Constrained Settings. J Infect Dis 213:1074-8
Chan, Ellen S; Landay, Alan L; Brown, Todd T et al. (2016) Differential CD4+ cell count increase and CD4+ :  CD8+ ratio normalization with maraviroc compared with tenofovir. AIDS 30:2091-7
Maddali, Manoj V; Gupta, Amita; Shah, Maunank (2016) Epidemiological impact of achieving UNAIDS 90-90-90 targets for HIV care in India: a modelling study. BMJ Open 6:e011914
Basavaraj, Anita; Chandanwale, Ajay; Patil, Akhil et al. (2016) Tuberculosis Risk among Medical Trainees, Pune, India. Emerg Infect Dis 22:541-3
Frew, Paula M; Parker, Kimberly; Vo, Linda et al. (2016) Socioecological factors influencing women's HIV risk in the United States: qualitative findings from the women's HIV SeroIncidence study (HPTN 064). BMC Public Health 16:803
Mave, V; Chandanwale, A; Kinikar, A et al. (2016) Isoniazid hair concentrations in children with tuberculosis: a proof of concept study. Int J Tuberc Lung Dis 20:844-7
Gupta, Amita; Montepiedra, Grace; Gupte, Akshay et al. (2016) Low Vitamin-D Levels Combined with PKP3-SIGIRR-TMEM16J Host Variants Is Associated with Tuberculosis and Death in HIV-Infected and -Exposed Infants. PLoS One 11:e0148649

Showing the most recent 10 out of 89 publications