2012 — 2016 |
Van Wagoner, Nicholas J |
K23Activity Code Description: To provide support for the career development of investigators who have made a commitment of focus their research endeavors on patient-oriented research. This mechanism provides support for a 3 year minimum up to 5 year period of supervised study and research for clinically trained professionals who have the potential to develop into productive, clinical investigators. |
Inhibition of Herpes Simplex Virus Type 2 by Tenofovir @ University of Alabama At Birmingham
DESCRIPTION (provided by applicant): Herpes Simplex Virus Type 2 (HSV-2) is a common infection that causes a spectrum of clinical disease from mild mucocutaneous, anogenital ulcers to life-threatening conditions. Prevention of HSV-2 infection is difficult and current therapy for HSV-2 is not completely effective. Immunocompromised persons such as those with HIV are particularly vulnerable to HSV-2, manifesting more severe disease and developing higher rates of resistance to therapy. For these reasons, new, more effective therapeutic agents are needed to prevent and treat HSV-2 infection and disease, respectively, especially in persons with HIV. Recent clinical and in vitro data suggest that agents, developed for the treatment of HIV, may also have activity against HSV-2. Most compelling are data suggesting that a Tenofovir Disoproxil Fumarate (TDF)-based, vaginal microbicide reduces HSV-2 acquisition. As an extension of this finding and based on our preliminary research, I hypothesize that TDF will have direct activity against HSV-2 in vitro and that orally delivered TDF, as a component of HIV therapy, will have activity against HSV-2 in vivo. To test this hypothesis, I propose the following independent but inter-related aims. Aim 1: Investigate the potential inhibitory role of TDF on HSV-2 replication in vitro. Aim 2: Determine the potential suppressive effect of systemically delivered TDF on HSV-2 infection and its suppressive effect on subclinical HSV-2 viral shedding in vivo. Using bidirectional and translational techniques as outlined in this proposal, I will establish a fundamental understanding of TDF's action on HSV-2 while providing information about clinical relevance. Of equal importance, this career development award and the research aims as outlined above are designed to provide me with additional training in virology, clinical study design, methodology, and statistical analysis to meet my specific educational needs. The opportunities created by this career development award will culminate in the creation of a translational scientist with the skills necessary to adeptly, ethically, and accurately answer important scientific questions related to HSV-2 prevention and treatment. It will also help me to successfully obtain future independent funding, and most importantly, improve patient care. Public Health Relevance: Infection with Herpes Simplex Virus Type 2 in immunocompromised populations, such as patients with HIV, is of particular concern because it can cause severe disease and harbor resistance to drug treatment in this population. There is need to identify new agents that effectively prevent and treat HSV-2, especially in HIV infected populations. In this grant, I will investigate Tenofovir's (TDF) anti-HSV-2 activity in vivo and in vitro.
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2014 — 2018 |
Van Wagoner, Nicholas J |
U19Activity Code Description: To support a research program of multiple projects directed toward a specific major objective, basic theme or program goal, requiring a broadly based, multidisciplinary and often long-term approach. A cooperative agreement research program generally involves the organized efforts of large groups, members of which are conducting research projects designed to elucidate the various aspects of a specific objective. Substantial Federal programmatic staff involvement is intended to assist investigators during performance of the research activities, as defined in the terms and conditions of award. The investigators have primary authorities and responsibilities to define research objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations and conclusions of their studies. Each research project is usually under the leadership of an established investigator in an area representing his/her special interest and competencies. Each project supported through this mechanism should contribute to or be directly related to the common theme of the total research effort. The award can provide support for certain basic shared resources, including clinical components, which facilitate the total research effort. These scientifically meritorious projects should demonstrate an essential element of unity and interdependence. |
Discis Clinical Core @ University of Alabama At Birmingham
DiSCIS Clinical Core Abstract The overarching goal of the Clinical Core is to engage, enroll, and retain participants in the Discharge Syndromes: Concordance and Interactions Study (DiSCIS) application. The investigators recognize the central role that human subjects play in this application and also the sensitivity of the information collected from study participants. All researchers will adhere to the highest level of ethical behavior in order to protect the physical and emotional wellbeing of the participants. The Clinical Core will support all projects outlined in the proposal through recruitment and performance of all clinic visits, including screening, initial, and subsequent study visits. Recruitment and all clinic events will be centralized at the Jefferson County Department of Health (JCDH) STD Clinic. In 2012, 16,119 patients (males=7,360 and females=8,759) received sexual health care at the JCDH STD Clinic. High prevalence of discharge syndromes including nongonococcal urethritis (about 25% of men), bacterial vaginosis (about 50% of women), and Chlamydia trachomatis (about 12% overall) are diagnosed and treated in this clinic. The JCDH STD Clinic and the University of Alabama (UAB) STD Program have an enduring partnership in STI research and STI-related patient care and a strong infrastructure already exists in this clinic for STI-related research. To maximize the success of the Clinical Core, we have assembled a clinical team with experience in designing, performing and completing longitudinal STI studies including couples studies. The specific aims for the Clinical Core are: (1) To centralize recruitment of men and women in regular sexual partnerships to create a cohort of participants to support all proposed projects, (2) To retain men and women in regular sexual partnerships for the duration of the study period, and (3) To collect accurate and complete participant information and biologics while protecting participant confidentiality. By supporting Projects 1-3, the Clinical Core will help to create new knowledge, advance diagnostic tools, and optimize therapy related to the most common discharge syndromes. The Clinical Core and its tight linkage to the Laboratory Core will ensure collection of quality specimens, efficiency and cost savings. The collective expertise of the Clinical Core team in clinical research study design, participant recruitment, and participant retention in prospective STI research including sexual dyad studies will provide a strong foundation for the success of all DiSCIS Projects while adhering to the highest standards of clinical research.
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