Hillsborough County Health Department Research Unit

• www.FLHIVresearch.com (will open in new window) 

Principal Investigator List

Todd Wills, MD, Principal Investigator

A Phase 2, randomized study of the treatment of antiretroviral treatment-experienced, HIV-1 Infected subjects comparing Ritonavir-boosted GS-9137 (GS-9137/r) versus a comparator ritonavir-boosted protease inhibitor (CPI/r) in combination with a background antiretroviral therapy [GS-US-183-0105]

A multicenter, randomized, double-blind, placebo-controlled trial of a novel CCR5 antagonist, UK-427,857, in combination with optimized background therapy versus optimized background therapy along for the treatment of antiretroviral-experienced HIV-1 infected subjects. Pfizer A4001027

An open-label trial with TMC125 as part of an ART including TMC114/rtv and an investigator-selected OBR in HIV-1 infected subjects who participated in a DUET trial (TMC125-C206 or TMC125-C216). TMC125-C217

Charurut Somboonwit, MD, Principal Investigator

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. Merk- IISP (2008-present).

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. (2007-present).

A Phase II, randomized, blinded, 12-week comparison of Elvucitabine in combination with Efavirenz and Tenofovir versus Lamivudine in combination with Efavirenz and Tenofovir in HIV-1 infected, treatment-naive subjects, with a 12-week extension treatment period [ACH443-015]

JHU- Pilot study for a multisite HIV/AIDS clinical and resource use data

Vicriviroc in combination treatment with an optimized ART regimen in HIV-infected treatment-experienced subjects [VICTOR-E4]

Beata Casanas, DO, Principal Investigator

Recurrent Tuberculosis: A new look at treating an old enemy. The purpose of this research is to (1) Study the recurrence rate of Tuberculosis in HIV negative and HIV positive patients (2) Look at this patient population and determine if a difference exists between the recurrence rates and lengths of treatment (3) Compare this to current CDC recommended treatment regimen lengths for HIV positive and negative patients. (5/2009-present).

A 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 patients. Tibotec (TMC278-TiDp6-C209). (2/2008-present).

Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Two-Stage Study to Assess the Efficacy and Safety of Crofelemer 125mg, 250 mg, and 500 mg Orally Twice Daily for the Treatment of HIV-Associated Diarrhea (ADVENT Trial). Napo Pharmaceuticals (NP303-101 ADVENT) (06/2007-present).

A Phase IIb, randomized, partially blinded, dose-finding trial of TMC278 in antiretroviral naïve HIV-1 infected subjects. Tibotech [TMC278-204]

A 96-week, Phase IV, randomized, double-blind, multicenter study of the safety and efficacy of Epzicom versus Truvada administered in combination with Kaletra in antiretroviral-naive HIV-1 infected subjects [EPZ104057] HEAT

Randomized, double-blind, parallel-group, placebo-controlled, two-stage study to assess the efficacy and safety of Crofelemer 125 mg, 250 mg, and 500 mg orally twice daily for the treatment of HIV-associated diarrhea [ADVENT Trial]

Douglas Holt, MD, Principal Investigator

A probe study to evaluate the safety, tolerability, and immunogenicity of the MRK adenovirus serotype 5 vector (MRKAd5) human immunodeficiency virus type I (HIV-1) gag vaccine in HIV-1 infected individuals. Merck V520

Early access of TMC114 in combination with low-dose Ritonavir (RTV) and other antiretrovirals (ARVs) in highly treatment experienced HIV-1 infected subjects with Limited or no treatment options [TMC114-C226]

A multicenter, double-blind, randomized, active-controlled study to evaluate the safety and antiretroviral activity of MK-0518 versus KALETRA in HIV-infected patients switched From a stable KALETRA based regimen – Study A [Protocol No. 032]

Steps to a Helathier Hillsborough County. Health and Human Services, 2004-09

Jose Montero, MD, Principal Investigator

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]

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]

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

A Phase III, double blind, randomized study to evaluate safety and efficacy of BAL8557 versus voriconazole for primary treatment of invasive fungal disease caused by Aspergillus species or other filamentous fungi.

A randomized, controlled, open-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, followed by an open-Label period on the recommended dose of TMC114/RTV. [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] 

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-naive HIV-1 infected HLA-B*5701 negative subjects [Protocol No: EPZ108859] ARIES

Other Funded Research

Heinzel F. DOD PT 073012. Traumatic Drain Injury Concepts Grant "Pathogenesis of Heterotopic Ossification in Traumatic Brain Injury" (03/17/08 - 09/16/09).

Toney J, Gompf SG, Oehler RA. A Phase II, Multicenter, Randomized, Double-Mask, Double-Dummy Study Comparing the Efficacy and Safety of Peramivir Administered Intravenously Once Daily versus Oseltamivir Administered Orally Twice Daily in Adults with Acute Serious or Potentially Life-Threatining Influenza. Biocryst. 2008.

Pavan PR, Gompf SG (Site PI), et al: Longitudinal Study of the Ocular Complications of AIDS, NIH/National Eye Institute - Johns Hopkins, University of South Florida College of Medicine, 2000-2004, renewed 2005-2008.

Heinzel F. NIH Training Grant T32-AI 07024-26 "Training in Geographic Medicine and Infectious Diseases" (09/01/03 - 08/31/08).

Toney J, (Site PI), Gompf S, Oehler R. VA Cooperative Grant CSP#403(c) Shingles Prevention Study (SPS) Long Term Persistence Study (5 year study), 2006 - present, (95% effort).

Toney J (Site PI), Oehler R, Gompf S. A Phase 2 randomized study investigating the safety, efficacy and pharmacokinetics of Daptomycin, 6mg/kilogram versus comparator (Vancomycin or Teicoplanin) in the treatment of subjects undergoing surgical standard of care for Osteomyelitis associated with an infected prosthetic hip or knee joint caused by methicillin-resistant staphyloccus aureus and/or coagulase negative staphylocci. Cubist Pharmaceuticals. 2007-present.   

Gompf S, Oehler R (Site PI). Open-label, limited access protocol of posaconazole (SCH 56592) in invasive fungal infections. Schering Plough, 2006. [P02095]

Gompf S (Site PI). A randomized, multicenter, open label, Phase IV study evaluating the efficacy and safety of 16-week versus 24-week treatment with PEGASYS/Copegus in interferon-naive patients with chronic hepatitis C genotype 2 or 3 virus infection, Roche, 2004-2006. [NV17317C]

Heinzel F (PI). CD40 and IFNgamma co-regulate IRF3 anti-viral responses.

Kharsan-Dabaja M, Vincent A, Greene J. Retrospective review of Voriconazole vs. Fluconazole for prophylaxes of mold infections with acute GVHD in allogenic HSCT, Pfizer, 2007.

Investigator Inititated Non-Funded Protocols

Wills T, Mohapatra S, Co-I. Evaluating the diagnostic performance of an HIV assay to detect antibodies in urine specimens.

Logan J (PI). University of South Florida. Evaluation of Cervical Cancer Screening Practices for HIV-positive Women.  This study examines secondary data to evaluate whether HIV-infected women receive CDC-recommended cervical cancer screening, and how demographic factors impact receipt of this screening.

Logan J (PI), Menezes L (Co-I), Somboonwit C, Kurtyka D (PI). (2007) Evaluation of cervical cancer screening pracitces among HIV-positive women.

Menezes (PI). University of South Florida. Disease Progression and Health Change Patterns among HIV-positive Patients at the Hillsborough County Health Department.  This study uses secondary data to examine a cohort of HIV-infected persons to determine disease progression and mediation factors. (09/06 – 09/09).

Grants

CDC Funded

Toney JF (PI), Schmitt K. Sexually transmitted diseases/human immunodefiency virus prevention training centers, Centers for Disease Control and Prevention (CDC), 2006, renewed 2007, 2008.

Toney JF (PI), Schmitt K. Supplemental funding for STD Prevention Training Cetner Ask Screen Intervene Curriculum training. April 2006 - March 2007.

HHS Funded

Haight DO, Agency Head, Diabetes Education Program. Polk Health Care Community Outreach Grants. 2006 - 2007.

Haight DO, Agency Head, Protocol for Assessing Community Excellence in Environmental Health (PACE-EH). Florida Department of Health, Division of Environmental Health. 2006 - 2007.

Haight DO, Agency Head, Vote and Vaccinate. Robert Wood Johnson Foundation Vote and Vax. 2006 - 2007.

Haight DO. Agency Head, Hispanic Obesity Prevention Education (HOPE) Project. Florida Department of Health. 2007.

Haight DO, Principal Administrator. Ryan White Title III HIV/AIDS Early Intervention Care Grant.  Health and Resource Services Administration (HRSA). 2000-2003, 2007-2012.

Haight DO, Agency Head, Family Planning Project Grant. Title X Program. FY 2007-2010.

Haight DO, Agency Head, Teen Pregnancy Prevention Grant. Polk Health Care Community Outreach Grant. FY 2007-2008, renewed FY 2008-2009. 

Haight DO, Agency Head, Reducing Oral Health Disparities (County Health Department Dental Initiatives).  Florida Department of Health. FY 2007-2008.

Haight DO, Agency Head, Worksite Wellness Mini-Grant.  Bureau of Chronic Disease Prevention and Health Promotion Obesity Prevention Program.  FY 2008-2009.