Florida Department of Health - Hillsborough County: Research Unit

Please visit our web site for additional information regarding research and programs at www.FLHIVresearch.com.

Principal Investigator List

Todd Wills, MD, Principal Investigator

A Phase 2, Open-Label, Multicenter Study of the Safety of Ritonavir-Boosted GS 9137 (GS 9137/r) Administered in Combination with Other Antiretroviral Agents for the Treatment of HIV 1 Infected Subjects.

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Positive, Antiretroviral Treatment- Naïve Adults [Protocol: GS-US-292-0104].

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Positive, Antiretroviral Treatment-Naïve Adults. [Protocol: GS-US-292-0111]

A Phase 3, Open-Label Study to Evaluate Switching from a TDF-Containing Combination Regimen to a TAF-Containing Combination Single Table Regimen (STR) in Virologically-Suppressed, HIV-1 Subjects [Protocol: GS-US-292-0109]

A Phase 3 Open-label Safety Study of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen in HIV-1 Positive Patients with Mild to Moderate Renal Impairment [Protocol: GS-US-292-0112]

A Phase 3, Two-Part Study to Evaluate the Efficacy of Tenofovir Alafenamide versus Placebo Added to a Failing Regimen Followed by Treatment with Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Plus Atazanavir in HIV-1 Positive, Antiretroviral Treatment-Experienced Adults [Protocol No. GS-US-292-0117]

A Phase 3 Open-label Study to Evaluate Switching from Optimized Stable Antiretroviral Regimens Containing Duranavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir 4 Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) plus Duranavir (DRV) in Treatment Experienced HIV-1 Positive Adults [Protocol No. GS0US-292-0119]

A Phase 3, Randomized, Double-Blind, to evaluate Switching from a Regimen Consisting of EFV/FTC/TDF FDC to FTC/RPV/TAF FDC in patient with virologically controlled HIV-1 infection [Protocol No. GS-US-366-1160]

A Phase 3, Randomized, Double-Blind, to evaluate Switching from a Regimen Consisting of FTC/RPV/TDF FDC to FTC/RPV/TAF FDC in patient with virologically controlled HIV-1 infection [Protocol No. GS-US-366-1216]

Charurut Somboonwit, MD, Principal Investigator

Center for Disease Control (CDC), Positive Health Check Evaluation Trial

NHLBI/DAIDS- REPRIEVE Funded, Randomized Trial to Prevent Vascular Events in HIV

Florida Cohort, A longitudinal cohort study in collaboration with the University of Florida, will enroll up to 1,500 participants with HIV infection and an additional 200 without HIV across the state of Florida.

IMPAACT 1077HS 

HAART Standard Version of the PROMISE Study (Promoting Maternal and Infant Survival Everywhere)

DAIDS-START, Strategic Timing of Antiretroviral Therapy. CPCRA START

John Hopkins University, Pilot Study for a Multisite HIV/AIDS Clinical and Resource Use Data

Jose Montero, MD, Principal Investigator

A Phase 3 Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Doravirine (MK-1439) 100 mg Once Daily Versus Darunavir 800 mg Once Daily plus Ritonavir 100 mg Once Daily, Each in Combination with Truvada or Epzicom, in Treatment-Naïve HIV-1 Infected Subjects [MK1439-018]

A Multicenter, Double-blind, Randomized, 2-Part, Dose ranging Study to Compare the Safety, and Antiretroviral Activity of MK-1439 Plus Truvada Versus Efavirenz Plus Truvada in Antiretroviral Treatment-Naïve, HIV-1 Infected Patients [MK1439 PN 007]

Beata Casanas, DO, Principal Investigator

Clofazamine use in the Long –Term Treatment of Leprosy. DOH IRB # 2107777538; FDA IND Number 67,0333; CDC IRB # 5811

Jamie Morano, MD, Principal Investigator

Bristol-Myers Squibb Virology Grant #AI424-556 Morano (VA PI) Paruolo (USF PI) "The Florida CORAAL Study: Cardiovascular Outcomes and Response on Aspirin in HIV/AIDS in Latinos Assessing Cardiovascular Disease Risk Factors in an HIV positive, Multicultural Cohort: A 10 year retrospective analysis using American Heart Association / American College of Cardiology (AHA/ACC) identified risk factors." University of South Florida and Veteran's Administration Grant Initiative.

John Toney, MD, Principal Investigator

Toney JF, Gompf SG, Oehler RA. Efficacy, Immunogenicity, and Safety Study of Clostridium difficile Toxoid Vaccine in Subjects at Risk for C. difficile Infection. Sanofi Pasteur. 2014-present.

Other Funded Research

Alrabaa, S. Rempex 505 A phase 3 Multicenter Randomized Double Blind, Double Dummy Study To Evaluate The Efficacy, Safety and Tolerability of Crabavance (Merropenem/RPX7009) Compared to Pipercillin/Tazobactam In the Treatment of Complicated Urinary Tract Infections In Adults. Tampa General Hospital, Tampa Florida

Alrabaa, S. A phase 3 Multicenter Randomized Open label Study of Carbavance (Merropenem/RPX7009) Versus Best Available Therapy in Subjects with Selected Serious Infections Due to Carbapenem- Resistant Enterobacteriaceae Tampa General Hospital, Tampa Florida

Alrabaa, S. F.Hoffman-La Roche NV20234, A Double Blind, Randomized, Stratifies, Multicenter Trial evaluating Conventional and High Dose Oseltamivir in the Treatment of Immunocompromised Patients with Influenza, Tampa General Hospital, Tampa Florida

Aslam, S. Principal Investigator for Women's Health Collaborative Grant on eating disorders, funding received April, 2013-2015

Aslam, S. Research funding from Tampa General Hospital for providing medical writing, research related services and support for investigator initiated studies and conducting collaborative research with clinicians, 2007-present

Morano, J. The AIDS Institute #041415 Lieb (PI) Morano (site-PI) "mAAP Project: Florida Mobile Application Adherence Project", Innovative pilot project to improve antiretroviral therapy adherence using a mobile phone application called Care4Today (Janssen Pharmaceuticals) among HIV positive individuals within three counties of the Florida Department of Health (Hillsborough, Orange, and Seminole).

Investigator Inititated Non-Funded Protocols

Alrabaa, S. Incidence and outcome of Intermediate Quantiferon test in immunocompromised population, Objective is to design a management protocol, 2015 - Current

Alrabaa, S. Incidence and outcome of Positive Strongylodies serology in the Solid organ Transplant Population, Objective is to design a management protocol, 2015 - Current

Alrabaa, S. Outcome of Fecal Microbiota Transplantation in severe Clostridium difficile infection in immunocompromised and immunocompetent population. Retrospective study with the Objective is to improve current protocol developed by investigator, 2015 - Current

Alrabaa, S. Understanding the Medical Value of Tests to Diagnose Bloodstream Infection. Objective: Prospective study to identify clinical perceptions about the utility of laboratory tests to diagnose patients with bloodstream infections using a physician survey, Tampa General Hospital, Tampa Florida, 2013-2014

Alrabaa, S. Investigating Increasing Fluconazole resistance among Cryptococcus neoformans isolates Objective: Prospective study to study fluconazole resistance in fungal infections, 2012 - Current

Grants

Gompf, S. VA GME Enhancement Grant Award in Critical Needs and Emerging Subspecialties: Healthcare Associated Infections, Academic Year 2009-present.

Gompf, S. VA GME Enhancement Grant Award in Critical Needs and Emerging Subspecialties: Infections in Polytrauma, Academic Year 2008-present.

Morano, J. Pfizer, Inc. 9689105 / U60957-01102014 Sultan (co-PI) Grant for Learning and Change, The "VaccineLink" Project / "La Salud Conexión" This two year nationally competitive project launched a community-based participatory research project for deploying innovative tablet consent, survey, and video voiceover technologies that utilized vaccine health navigators to education on adult vaccine literacy and uptake among populations in Florida, Hillsborough and Polk counties. Collaboration with Florida Department of Health-Hillsborough Refugee/Vaccination Division and the state-wide FloridaShots registry.

Sinnott, JT, Knox, M (Co-PIs) Wills TS (Co-Investigator) HRSA – Special Programs of National Significance Hepatitis C Treatment Expansion Imitative Evaluation and Technical Assistance Center (ETAC) U90HA19469-01-00 (9/2010 – 8/2014) 25% USF effort (refereed)

Toney JF,Gompf SG, Oehler RA. VA Cooperative grant CSP #403(c) Shingles Prevention Study (SPS) Long Term Persistance Study (5-year study). 2006-2010. 

Toney JF,Schmitt K. Sexually Transmitted Diseases/Human Immunodeficiency Virus Prevention Training Centers (Funding Opportunity Number: PS06-606 R30 Cooperative Agreement) Centers for Disease Control and Prevention (CDC), 2006. Renewed 2007, 2008, 2009, 2010.

HHS Funded

Choe, U. Public Health Services and Systems Research: Study of Local Agency QI Interventions to Improve Cost Effectiveness of Delivering Sexually Transmitted Infections (STI) Service; FDOH, UF, and Practice Based Research Network, 2015. Choe, U. Florida Public Health Training Center Collaborative Project: Health Department Research Day, FDOH-Polk and USF College of Public Health, 2013.

Haight, DO. Ryan White Title II HIV/AIDS Outpatient and Ambulatory, Health and Support Services, For Individuals with HIV Disease and Their Families,Agency Head; Terry Boysel Program Manager. Federal Health Resources and Service Administration (HRSA).  Apr 2011 - Mar 2014 (3 year cycle)

Haight, DO. Closing the Gap: Improving HIV Testing for Heterosexual African American Women sub recipient of grant. Agency Head; Woody Wilbanks Project Manager. State of Fla Office of Minority Health, West Bartow Front Porch. FY 2009-2012.

Haight, DO. Community Based Tobacco Interventions Grant. Agency Head; Jennifer Tempel Program Coordinator. Florida Dept. of Health. FY 2009-2012.

Haight, DO. Increasing Enrollment in KidCare sub recipient of grant. Agency Head; Linda Hawbaker Project Director. University of South Florida, College of Public Health. FY 2010-2011.

Haight, DO. Support for Healthcare to the underinsured and uninsured. Agency Head; Lynne Saddler Project Director. Low Income Pool Fund. FY 2008-2011.

Haight, DO. Ryan White Part B & C Grant for HIV Intervention, Case Management, Labs, Oral Care, Prenatal Service, and Housing (HOPWA). Agency Head; Terry Boysel Program Manager. Federal Health Resources and Service Administration (HRSA).FY 2008-2009. FY 2009-2010.

Haight, DO. School Based Influenza Vaccinations. Agency Head; Michele Ford Project Manager. The American Recovery and Reinvestment Act. FY 2009-2010.

Haight, DO. Petroleum Contamination Site Cleanup for Polk, Highlands, Hardee, and Osceola Counties. Agency Head; Corey Franklin Project Director. Florida Department of Environmental Protection.  January – June 2010.

Haight, DO. Tdap for Men to Prevent Pertussis in Newborns. Agency Head; Nancy Keating Project Director. Fla. Assoc. of Public Health Nurses, Inc. FY 2010.

Haight, DO. Developing Evaluation Tool for a Community Health Improvement Plan. Agency Head; Linda Hawbaker Project Manager. Healthy Communities Healthy People Program of the Florida Department of Health. FY 2010.

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