Hillsborough County Health Department Research Unit

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Principal Investigator List

Todd Wills, MD, Principal Investigator

A multimember randomized, double-blind, controlled study of NGX-4010 for the treatment of painful HIV-associated neuropathy. [NGX-C119]

A Phase III randomized, double-blinded, placebo-controlled trial to investigate the efficacy, tolerability and safety of TMC125 as part of an ART including TMC114/RTV and an investigator-selected OBR in HIV-1 infected subjects with limited to no treatment options. [TMC125-C206]

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

A multicenter randomized, double-blind, controlled study of NGX-4010 for the treatment of painful HIV-associated neuropathy. NeurogesX Protocol C119

Charurut Somboonwit, MD, Principal Investigator

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

A large, simple trial comparing two strategies for management of anti-retroviral therapy. [SMART CPCRA 065]

A randomized, controlled, open-label trial to compare the efficacy, safety and tolerability of TMC114/ritonavir versus lopinavir/ritonavir in treatment-naïve HIV-1 infected subjects. This trial will be referred to as ARTEMIS. [Protocol No. TMC114-211]

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

Beata Casanas, DO, Principal Investigator

A Phase III, randomized, open-label study of lopinavir/ritonavir tablets 800/200 mg once-daily versus 400/100 mg twice-daily when co-administered with nucleoside/nucleotide reverse transcriptase inhibitors in antiretroviral-experienced, HIV-1 infected subjects. Abbott Laboratories [M06-802]

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 anti-retroviral-experienced, HIV-1 infected subjects. GlaxoSmithKline [EPZ104057]

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

An open-label trial with TMC125 in HIV-1 infected subjects, who were randomized to a TMC125 treatment arm in a sponsor-selected TMC125 trial and were treated for at least 48 weeks. Tibotech [TMC125-C229]

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

A randomized, prospective study of the efficacy, safety and tolerability of two doses of GW433908/Ritonavir given with Abacavir/Lamivudine fixed dose combination. GlaxoSmithKline [COL100758]

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]

Jose Montero, MD, Principal Investigator

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

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 urines specimens.

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

Menezes L (PI), Logan J (Co-I), Zhu Y (Co-I) Somboonwit C, Yangxin H. (2007). Disease progression and health change patterns among HIV-positive patients at the Hillsborough County Health Department. Analzying data and preparing initial manuscript. 

Menezes L (PI), Wills T (CO-I) Wang T (Co-I). (2007) Disease progression and health change patterns among HIV-positive patients at the Hillsborough County Health Department. Analyzing data and preparing initial manuscript.

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.

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.