Department of Pharmacy Practice

College of Pharmacy
masthead

Pharmacy Practice Sponsored Research

   Jeffrey Bishop, PharmD

Title:

Schizophrenia Pharmacogenetics cognition and symptom response to antipsychotics
Sponsor:

National Institute of Mental Health
Summary:

The purpose of this study is to investigate the relationship between genetic markers and cognitive and symptom outcomes in patients with schizophrenia who are treated with antipsychotic agents


   Larisa Cavallari, PharmD

Title:

Comprehensive studies of novel SNPs affecting warfarin dose in African Americans
Sponsor:

University of Chicago (National Heart, Lung and Blood Institute)
Summary:

To identify novel variation in several candidate genes that predicts variability in warfarin dose requirements in African Americans as well as examine the functional consequences of individual VKORC1 and CYP2C9 SNPs and haplotypes in an in vitro-based method. Also to investigate the role of associated SNPs on Vitamin K Oxidative Reductase (VKOR) function and warfarin pharmacokinetics in humans.


   Larry Danzinger, PharmD

Title:

A Randomized, double-blinded, active-controlled study of CB-183, 315 in Patients with Clostridium Difficile Associated Diarrhea
Sponsor:

Cubist Pharmaceuticals, Inc.
Summary:

CDAD continues to be an important medical problem with rates and disease severity increasing, due in part to the spread of the C. difficile epidemic toxigenic strain. While the primary infection can be successfully treated in many patients, approximately 25% of patients experience recurrent CDAD, which is a serious problem contributing to the overall morbidity of patients with this disease. The high recurrence rate following vancomycin therapy is likely related to the disruptive effect of vancomycin on normal bowel flora. Therefore, reducing CDAD recurrence rates and improving outcomes of severe disease remain significant unmet medical needs. CB-183,31 is an orally administered lipopeptide that demonstrates potent and rapid bactericidal activity against clinical C. difficile isoles. This is a randomized, double-blind, active-controlled design with 2 treatment arms. A 250 mg bid dose regimen of CB-183,315 will be compared with the active comparator oral vancomycin. Subjects with diarrhea at risk for CDAD will be identified and tasted for the C. difficile toxin.


   Jim Fisher, PharmD

Title:

Open-label study to assess the safety and tolerability of intravenous carbamazepine as short-term replacement of oral carbamazepine in adult patients with epilepsy
Sponsor:

Lundbeck Inc.
Summary:

This is a phase III, multi-center, open-label study designed to assess the safety and tolerability of an intravenous formulation of carbamazepine in adult patients with epilepsy. This study includes a 27-day Lead-in Period, a Confinement Period (up to 7 days and 6 nights), and a 28-day Follow-up Period.  During the confinement period, the subject's oral dose of carbamazepine is replaced by an equivalent intravenous dose.  Approximately 105 patients with a minimum of 40 patients taking a high dose of carbamazpine (1600 – 2000 mg/day) will be enrolled across all sites.


    Kristen Goliak, PharmD

Title:

Medication Monitoring & Safety in Older Adults (MMSOA): A community-based educational outreach program
Sponsor:

Age Options
Summary:

University of Illinois pharmacy faculty and students provide community based health promotion targeting medication safety and awareness in at-risk seniors in the Chicagoland area. Specifically, the program provides for screening, assessment and evaluation of senior medication drug regimens through one-on-one review and evaluation. In addition, we strive to promote Healthy People 2020 goals and empower senior’s to take control of their health through recommended vaccinations, educational topic discussions, using their medications wisely, making positive health care choices and encouraging effective open communication with their physicians.


   Hyun-Young Jeong, PharmD

Title:

Altered Drug Metabolism in Pregnancy
Sponsor:

National Institute of Child Health Development
Summary:

Over 50% of pregnant women take one or more prescription drugs due to pre-existing or newly developing medical conditions. Despite the prevalent use of medications, how pregnancy alters drug disposition is poorly understood. Accurate pharmacokinetic information is crucial for pregnant women because under or over dose may result in detrimental clinical outcomes in both mother and fetus. Clear understanding of altered drug disposition during pregnancy should enable prediction of pharmacokinetic changes of drugs in pregnant women. The aim of this study is to establish effects of estrogen and PRG and CYP expression and drug metabolism in human hepatocytes as well as determine molecular mechanisms by which expression of two major CYP enzymes, CYP3A4 and CYP2D6 is up-regulated during pregnancy.


Title:

Design and Synthesis of Nonpeptide Protease Inhibitors
Sponsor:

Purdue University (NIH)
Summary:

Acquired immunodeficiency syndrome (AIDS) is one of the most destructive epidemics in medical history.  In 2009, the UNAIDS report estimated that 35 million people are living with human immunodeficiency virus (HIV) infection and AIDS, 25 million deaths have occurred, and 14 million children have been orphaned since the epidemic began in 1981.  The discovery of HIV, the etiological agent for AIDS, led to the identification of a number of biochemical targets to combat this devastating disease.  Among them, therapeutic inhibition of a proteolytic enzyme, HIV-1 protease, emerged as a critical drug-development target.  Subsequent design and discovery of protease inhibitors (PIs) and their introduction into the highly active antiretroviral therapy (HAART), marked the beginning of a new era of management of HIV-1 infection and AIDS.  HAART significantly improved the quality of life and life expectancy of patients.  There is no cure for HIV/AIDS and long-term treatment has posed a serious challenge because of the emergence of multidrug-resistant HIV-1 variants.  About 40-50% of those patients who initially achieved favorable viral suppression to undetectable levels experienced treatment failure.  These drug-resistant HIV strains can be transmitted, raising further uncertainty with respect to future treatment options.  In addition, PIs are faced with a number of serious limitations including, major toxicity, tolerance, and adherence to complex medical regimens.  The development of a new generation of PIs effective against drug-resistant HIV and with minimum side effects, are vital to the future management of HIV/AIDS.  Our collaborative research efforts to combat drug resistance led to the development of darunavir, which was first approved for treatment against drug-resistant HIV in June, 2006, and then received full approval for all HIV/AIDS patients including pediatric patients in December, 2008.  While darunavir has become a front line therapy against HIV/AIDS, it is far from ideal as an effective long-term treatment option.  Darunavir is eliminated mainly by hepatic metabolism via cytochrome P450 (CYP)3A4.  For achieve efficacy, darunavir needs to be co-administered with ritonavir, a potent CYP3A4 inhibitor, and this is responsible for multiple drug-drug interactions in patients prescribed with darunavirs


   Jeremy Johnson, PharmD

Title:

Prostate Cancer Chemoprevention with Carnosol by dual Disruption of AR/ER
Sponsor:

American Cancer Society
Summary:

Our long-term goal is to understand how diterpenes including carnosol simultaneously disrupt AR and ERα for the prevention of prostate cancer.  Our central hypothesis is that diterpenes are dual AR and ERα disruptors that promote proteolytic degradation of AR and ERα decreasing the proliferative index of prostate cells.  Our hypothesis has been formulated on the basis of our own published data which was the first report of a single chemical entity, carnosol that was able to simultaneously disrupt AR and ERα without agonist properties.  Also, the work of several other groups evaluating diterpenes as either AR or ERα antagonists is supportive of our hypothesis.  We plan to test our central hypothesis and accomplish the objective of this proposal by pursuing the following:  Specific Aim 1.  To characterize the post translational and proteolytic events associated with carnosol induced degradation of AR and ERα in prostate cells. Specific Aim 2.  To determine if carnosol interacting with the ligand binding domain is necessary for proteolytic events associated with carnosol induced degradation of ERα in prostate cells.  Specific Aim 3.  To determine the stage specific chemopreventive efficacy of oral feeding carnosol on prostate cancer initiation and progression using the myc-driven transgenic prostate cancer mouse model.


   Alan Lau, PharmD

Title:

Identification of markers for determining the efficacy of vitamin D receptor activity therapy in Stage ¾ CKD patients
Sponsor:

Abbott Laboratories
Summary:

Death from heart disease is greater in chronic kidney disease (CKD) and dialysis patients compared to the general population. It may be possible that CKD is linked to heart deaths. Active vitamin D is made in the kidneys. When the kidneys stop working it does not make enough Vitamin D. The purpose of this research is to study how a patients body and their genes respond to vitamin D therapy. This study hopes to find specific indicators in patients which respond to vitamin D.


   Edith Nutescu, PharmD

Title:

Barriers to appropriate Anticoagulation with Warfare in Orthopedic Surgery
Sponsor:

Ortho McNeil Janssen
Summary:

The primary purpose of this study is to explore and describe the barriers and limitations of using traditional anticoagulants (warfarin and LMWH) for thromboprophylaxix after major orthopedic surgery of the lower extremeties (THR and TKR). This study will also conduct a comprehensive literature review to identify and analyze factors that hinder the use of traditional anticoagulants as effective prophylactic agents after MOS.


   Simon Pickard, PhD

Title:

Takeda Pharmaceuticals International and UIC 2-Year Fellowship in Health Economics and Outcomes (*TWO CONTRACTS ARE ONGOING)
Sponsor:

Takeda Pharmaceuticals
Summary:

The objective of this fellowship is to train independent health outcomes scientists with expertise and skills in health economics and outcomes research that can assume leadership positions in the pharmaceutical industry or academic. The goals of the fellowship are to enable the fellow to collaborate with other scientist to perform clinical, economic and/or humanist outcomes research, to use outcomes research skills to formulate a valid research question and study design, to demonstrate skills and knowledge in various methodologies.



   Keith Rodvold, PharmD

Title:

Pharmacokinetics of Ceftaroline in Normal and Obese Subjects
Sponsor:

Forest Research Institute, Inc.
Summary:

The prevalence of obesity is increasing, with the World Health Organization predicting >700 million people will be obese by 2015. “Severe” obesity is increasing at a greater rate than “moderate” obesity. Although obese individuals now account for a significant proportion of the population, there is little guidance on how to adjust drug doses when these individuals require pharmacological intervention. Clinical pharmacokinetic studies should be designed to sufficiently determine dosing metrics for the obese subjects. This investigation has elected to evaluate the current FDA-approved dosage of ceftaroline fosamil 700 mg administered by intravenous infusion.


   Glen Schumock, PharmD

Title:

UC/UIC Comparative Effectiveness Research Institutional Career Development Award (KM1)
Sponsor:

University of Chicago
Summary:

The Scholars chosen will participate in didactic and experiential training related to comparative effectiveness research as well as grantwriting, translational research and responsible conduct of research. As part of the Scholar’s professional development, he/she will be expected to propose and carry out a mentored research project and to apply for external research funding such as a NIH/AHRQ R-series grant.


Title:

Alternative Methods for Health Outcomes of Interest Validation
Sponsor:

Harvard Pilgrim Health (FDA)
Summary:

Accurate identification of patients experiencing adverse drug events/outcomes is of great importance to the validity of investigations of drug safety.  This is particularly true of studies of electronic databases, including the Mini-Sentinel Distributed Database (MSDD) where identification of such outcomes often rely on International Classification of Disease (ICD) codes, sets of codes, or combinations of codes and other variables (i.e., algorithms) in the data.  If these algorithms have low sensitivity or specificity then significant misclassification of health outcomes can occur.  To avoid this investigators use algorithms that have been previously validated against full-text medical record review as the “gold standard.”25-46  While many algorithms have been validated in this manner, fewer are available for outcomes associated with adverse drug events.  Furthermore, some validated algorithms are based on data that are too different from the MSDD for them to be useful for the Mini-Sentinel program.  While efforts are underway to conduct health outcomes of interest (HOI) algorithm validation against medical records within Mini-Sentinel, this process is very resource intensive, both in terms of time and money.  Because of the resource requirements for validation through medical records, alternative methods for validating outcomes of interest need to be explored.  Specifically, there is a need to consider more cost-efficient approaches to validating algorithms used to identify HOIs in the MSDD.  An obvious alternative to medical record review would be to identify databases that could be linked to MSDD (referred to as “linked HOI validation” hereafter) for a given HOI.