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 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9350-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered with Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults [Gilead – GS-US-216-0114]

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 versus Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults [Gilead - GS-US-236-0103]

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 versus Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults [Gilead – GS-US-236-0102]

A Multicenter, Randomized, Blinded, Placebo-Controlled Study to Evaluate the Safety of Maraviroc in Combination with Other Antiretroviral Agents in HIV-1 Infected Subjects Co-Infected with HEPATITIS C and/or HEPATITIS B Virus [Pfizer A4001098]

A Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Ritonavir-Boosted Elvitegravir (EVG/r) versus Raltegravir (RAL) Each Administered with a Background Regimen in HIV-1 Infected, Antiretroviral Treatment-Experienced Adults [Gilead – GS-US-183-0144]

Charurut Somboonwit, MD, Principal Investigator

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

Efficacy and Safety of Vicriviroc in HIV-Infected Treatment- Naïve Subjects [Schering- P04875] (A673DL)

A Pilot, Randomized, Controlled Study to Evaluate the Safety and Efficacy of Raltegravir versus NRTIs as a Backbone in HIV-Infected Patients Switched from a Stable Boosted PI Regimen [Merck – IISP 33107] (A673CG)

HIV and Cardiovascular Risks in an Urban Setting. A Retrospective Study for Cardiovascular Risk Factors Prevalent Among HIV Positive Patients Receiving Care in an Urban Health Department Located in Hillsborough County, FL

Vicriviroc in Combination Treatment with an Optimized ART Regimen in HIV-Infected Treatment-Experienced Subjects [Schering - P04889] (A673BK)

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

Jose Montero, MD, Principal Investigator

A Multicenter, Randomized, Double-blind, Comparative Trial of Maraviroc + Darunavir/Ritonavir versus Emtricitabine/Tenofovir + Darunavir/Ritonavir for the Treatment of Antiretroviral-Naive HIV-Infected Patients with CCR5-Tropic HIV [A4001095]

A Phase III, Randomized, Double Blind, Placebo Controlled Trial of Pregabalin on Peripheral Neuropathic Pain Associated with HIV [A00812244]

A Phase 2B Multicenter, Randomized, Comparative Trial of UK-453,061 versus Etravirine in Combination with Darunavir/Ritonavir and Nucleotide/Nucleoside Reverse Transcriptase Inhibitor for the Treatment of Antiretroviral Experienced HIV-1 Infected Subjects with Evidence of NNRTI Resistant HIV-1 [A5271022]

Pilot Study of Novel Combination of Maraviroc + Atazanavir/Ritonavir Vs. Atazanavir/Ritonavir + Emtricitabine/Tenofovir For The Treatment Of Treatment Naïve HIV-Infected Patients With R5 HIV-1 [A4001078]

The HIV Virologic Outcomes of Different Interventions among HAART Experienced Patients with Two Consecutive Detectable Low-Level Viremias [Bristol-Myers Squibb Virology Fellows Research Program]

A Phase III, Double Blind, Randomized Study to Evaluate Safety and Efficacy of BAL8557 Versus A Caspofungin Followed by Voriconazole Regimen in the Treatment of Candidemia and Other Invasive Candida Infections [WSA-CS-008]

A Phase III, Double Blind, Randomized Study to Evaluate Safety and Efficacy of BAL 8557 Versus Voriconazole for Primary Treatment of Invasive Fungal Disease Caused by Invasive Aspergillus Species or Other Filamentus Fungi [WSA –CS-004]

Safety and Efficacy of an Initial Regimen of Atazanavir + Ritonavir + the Abacavir/Lamivudine Fixed-Dose Combination Tablet for 36 weeks followed by Simplification to Atazanavir with the Abacavir/Lamivudine Fixed-Dose Combination Tablet or Maintenance of the Initial Regimen for an Additional 48 weeks in Antiretroviral-Naïve HIV-1 Infected HLA-B*5701 Negative Subjects [EPZ108859]

A Randomized, Controlled, Open-Label Trial to Compare the Efficacy, Safety and Tolerability of TMC114/RTV versus LPV/RTV in Treatment-Experienced HIV-1 Infected Subjects [TMC114-C214]

A Phase II Randomized, Controlled, Partially Blinded Trial to investigate Dose-Response of TMC114/RTV in 3-Class-Experienced HIV-1 Infected Subjects [TMC114-C202]

A Study of the Safety, Tolerability and Immunogenicity of HIV-1 Gag DNA Formulated with CRL1005 Adjuvant, Followed by the Adenovirus Serotype 5 HIV-1 Gag Vaccine (Ad5 HIV-1 gag) in a Prime/Boost Regimen [Merck V520-011]

Centers for Disease Control and Prevention/DHHS STD Knowledge and Attitude Survey in Incoming PGY-1 Primary Care Residents

Beata Casanas, DO, Principal Investigator

Open-label trial with TMC278 25 mg q.d. in combination with a background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors in HIV- 1 infected subjects, who participated in TMC278 clinical trials [Tibotec TMC278-TIDP6-C222)

Phase 3 Randomized, Open-Label Study to Evaluate Switching from Regimens Consisting of a Ritonavir-boosted Protease Inhibitor and Two Nucleoside Reverse Transcriptase Inhibitors to Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF) Fixed-dose Regimen in Virologically-Suppressed, HIV-1 Infected Patients [Gilead GS-US-264-0106]

Phase III, Randomized, Double-Blind Trial of TMC278 75mg qd versus Efavirenz 600 mg q.d. in Combination with Fixed Dose Background Regimen Consisting of Tenofovir Disoproxil Fumarate and Emtricitabine in Antiretroviral-Naïve HIV-1 Infected Subjects [Tibotec TMC278-TiDP6-C209]

Phase IIb, Randomized, Partially Blinded, Dose-Finding Trial of TMC278 in Antiretroviral Naïve HIV-1 Infected Subjects [Tibotec TMC278-2004]

Other Funded Research

Amuso, P. (Co-PI) U.S. Dept. of Defense (RDECOM). Enhancement of Public Health Preparedness against Bioterrorism: Strategic Approaches to Rapid Surveillance, Detection, and Protection against Potential Biological Pathogens (12/10 – 12/11)

Callegari, C. (PI) P LOCTI 1.150 Universidad de Carabobo. National Endowment for Science, Technology and Innovation, Venezuela. Comparative Nutritional Assessment and Intervention of Children and Adolescents from Venezuela and a Group of Descendants of Italian Immigrants: a Study Pilot (2006 – present)

Callegari, C. (PI). P LOCTI 1.149 Universidad de Carabobo. National Endowment for Science, Technology and Innovation, Venezuela. Characterization of the Aging Process in a Population of Italian Immigrants Living in Carabobo State Compared with Venezuelan Elderly Population (2006 – present)

Greene, JN. (PI) A Multicenter, Double-Blind, Randomized Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of MK-0991 versus (Amphotericin B) Liposome for Injection as Empirical Therapy in Patients with Persistent Fever and Neutropenia (2000 – present)

Greene, JN. (PI) An Open, Randomized, Comparative Multi-center Study of the Efficacy, Safety, and Toleration of Voriconazole versus Amphotericin B Followed by Other Licensed Antifungal Therapy in the Treatment of Acute Invasive Aspergillosis in Immunocompromised Patients (2000 – present)

Haight DO, Agency Head, Increasing Enrollment in KidCare Sub Recipient of Grant. University of South Florida, College of Public Health. FY 2010-2011.

Sinnott JT (PI), Knox M, Beal J, et al. Hepatitis C Treatment Expansion Initiative Evaluation and Technical Assistance Center. Health Resources and Services Administration (HRSA) (2010 – 2014)

Toney, JF (Co-I) Biostatistics in Medical & Health Research via Clinical Trials and Epidemiology (1T15 HL097780-01). NIH/National Heart, Lung, Blood Institute (08/20/2009 - 07/31/2012)

Investigator Inititated Non-Funded Protocols

Alrabaa, S. H. Lee Moffitt Cancer Center, Tampa. Invasive Pulmonary Fungal Infections in Neutropenic Patients; Radiological Patterns of Three Molds (11/10 – present)

Alrabaa, S. H. Lee Moffitt Cancer Center, Tampa. Bi-weekly CT Scan of the Lungs to Detect Early Invasive Pulmonary Fungal Infections in Neutropenic Patients (11/10 – present)

Menezes (PI). University of South Florida. Disease Progression and Health Change Patterns among HIV-Positive Patients at the Hillsborough County Health Department. (09/06 – 06/11)

Pavan PR, Oehler RL (Co-PI), et. al. USF College of Medicine. Longitudinal Study of the Ocular Complications of AIDS/National Eye Institute-Johns Hopkins, 2007-11

Grants

HHS Funded

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

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

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

Haight DO, Agency Head, Tdap Immunization to Men to Prevent Pertussis Spread in Newborns. Florida Association of Public Health Nurses, Inc. FY 2010

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

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

Haight DO, Agency Head, Closing the Gap: Improving HIV Testing for Heterosexual African American Women. Sub recipient of grant. State of Florida Office of Minority Health, West Bartow Front Porch. FY 2009-2012

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