The Clinical Research Unit was established in 1995 by Dr. Jeffrey Nadler through a partnership with the University of South Florida Health (USF) Division of Infectious Disease & International Medicine and the Florida Department of Health. Housed at the Florida Department of Health - Hillsborough County, we operate in conjunction with the Specialty Care Center, and conduct clinical research relevant to the HIV community which we serve. This program facilitates patients' access to research program opportunities, and provides a resource for the state of Florida in the development of state of the art treatment and diagnostics for HIV/AIDS. The Unit has conducted over 110 HIV research studies, including Phase I-IV pharmaceutical studies, investigational device and testing evaluations, epidemiologic, health services, and outcomes research.

This partnership benefits patient volunteers, the Florida Department of Health - Hillsborough County, and the Tampa Bay community. Approximately 50 patients per year participate in studies, with four to eight studies active at any time. Our patients gain:

• Early access to new drugs and lab tests
• More intensive disease management
• Access to qualified & experienced specialists
• Dedicated time to fully educate patients on advancements in HIV care

Our intensive disease management is reflected in our outcomes data. The complete response rate to HIV antiviral drugs in the general population is around 50%; research patients routinely achieve 85% response rates.

For the past 14 years, the Florida HIV Research Unit has assisted in 24 successful HIV clinical drug trials that are now commercially available on the market including the following: nucleoside/nucleotide reverse transcriptase inhibitors, non-nucleoside/non-nucleotide reverse transcriptase inhibitors, protease inhibitors, entry inhibitors, integrase inhibitors, and single tablet regimens.

Benefiting the Citizens of Tampa Bay

Volunteer patients who receive lab monitoring and antiviral therapy in HIV-related clinical trials offset billing that would otherwise be assigned to public funding sources (Hillsborough County Health Plan, Medicaid, Medicare, indigent funds, etc.) Associating with a facility that offers state-of-the-art diagnosis and management enhances the prestige of patients receiving care in the public sector.

Proven Research Experience

We have conducted over 110 HIV studies, which include three translational drug studies, eight translational immunotherapeutic trials, four lab/diagnostic trials, and two HIV vaccine trials. These experiences relate directly to our ability to recruit and retain large numbers of subjects in vaccine trials.

We provide our patients with state-of-the-art care, including research access that complements clinical care. The size and diversity of our HIV population and the breadth of previous studies are important indicators of future performance. Our research encompasses the following areas:

Optimization of Clinical Management

• Antiretroviral safety, adherence, resistance and durability of response
• Effectiveness of new regimens, better use of old
• Co-morbidity & antiretroviral management
• Complication management (metabolic adverse events, etc.)

Translational Research

• Development of agents addressing novel mechanisms/targets
• Immune-based therapies

Development of an HIV Vaccine

• Help decipher correlates of immune protection
• Development & testing of vaccine candidates

Vision for the Future

The current program is a model for development of systems expandable into other areas of primary care research: evaluation of new vaccines (pneumococcal conjugate vaccines, adult zoster vaccination), new antivirals (for common illnesses such as influenza) and new diagnostic tests (for better management of HIV, molecular diagnosis of STDs).

The clinical research partnership between the Florida Department of Health - Hillsborough County and the USF Health Division of Infectious Disease is already a success. With continued support, this effort can be expanded to provide new opportunities to even more patients, across a broader range of medical conditions common in our community.