The Johns Hopkins University is a national and international leader in HIV clinical research. The proposed Johns Hopkins University AIDS Clinical Trials Unit (CTU) will bring together three independently funded HIV clinical research groups that perform (1) adult and (2) pediatric treatment trials, and (3) HIV prevention research. These three groups will form a unified CTU serving three DAIDS clinical research networks at one Clinical Research Site (CRS), The Johns Hopkins Medical Institutions in East Baltimore. The Site will be affiliated with the proposed (1) AIDS Clinical Trials Group (ACTG) Network, (2) International Maternal Pediatric Adolescent AIDS Clinical Thais (IMPAACT) Network, (3) HIV Prevention Trials Network (HPTN). We have a long history of substantive contribution to the DAIDS scientific agenda, especially in the areas of prevention and treatment trials, early phase drug development and experimental therapeutics, neurology, hepatitis virus and HIV co-infection, and pediatric, adolescent, and maternal-fetal research. The investigators in this proposed CTU have authored over 1,000 published papers related to HIV infection, >300 of these in the past five years. The same investigators hold 21 HIV-related NIH-funded grants as Principal Investigator or Co-Principal Investigator for over $7,000,000 in annual direct costs. Our existing Adult ACTG Unit ranks first nationally in recruitment of African-Americans and women, many of whom have a history of substance abuse. Data management is rated outstanding, and subject retention is exemplary. The CRS will recruit from affiliated clinics serving more than 30,000 HIV-infected and at-risk persons. This new CTU will bring together a large group of accomplished investigators with a strong history of collaboration, and will allow consolidation of administrative resources for regulatory affairs, data management, outreach, and recruitment. While preserving the successful aspects of our current HIV clinical trials structure, this reorganization will benefit the institution by providing a centralized, shared administrative core, which will allow an economy of scale that has not previously been possible at Johns Hopkins. Above all, the joining together of these three groups will provide access to HIV prevention and treatment research across the age spectrum, from birth to adolescence to adulthood and senescence. This CTU is well-positioned to continue its broad and substantial contributions to national and international HIV clinical research, while also serving its community. ADMINISTRATIVE COMPONENT:

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Project with Complex Structure Cooperative Agreement (UM1)
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Special Emphasis Panel (ZAI1-MH-A (M1))
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Welsch, Sue A
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Johns Hopkins University
Internal Medicine/Medicine
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United States
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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

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