Clinical Research

A number of clinical studies are being conducted by faculty members of the Section of Infectious Diseases. This includes investigations of outpatient therapy for HIV infection and inpatient studies of newer antibacterial agents. Some studies are part of NIH-funded trials consortia, while others are multi-center studies of new agents or approaches to therapy being sponsored by industry. There are also investigator-initiated trials, some of which have a translational laboratory research component.

Current Global research areas include epidemiologic and social network studies of HIV, HSV-2 and Chlamydia infection in India and China, Novel HIV prevention strategies in Asia, HIV and STI seroepidemiologic studies in high-risk male cohorts such as truck-drivers and men who have sex with men. Cost-effectiveness of HIV therapy in Uganda. Cardiovascular and diabetes disease prevention in South Asia. Health worker migration patterns (“brain drain”), and pharmaceutical industry policy in India. These and other collaborative projects have been funded in part by the NIH, CDC, Lancet, foreign government, and private foundation and pharmaceutical support.

In addition, opportunities for global infectious disease operational research projects have been established by clinical training and research relationships established in Andhra Pradesh, India and in Wuhan, China. Specific projects under consideration are HIV prevention and health worker training in India and operational research in infectious disease and public health training in China.

The listing below is limited to studies being conducted by the Infectious Diseases Section that are actively accruing study participants.

Community Programs for Clinical Research on AIDS (CPCRA)

The AIDS Research Alliance of Chicago (ARAC) is the Chicago site of the CPCRA. The University of Chicago joined this trials consortium this year. The major trial that is ongoing and recruiting patients is the SMART (Strategies for Management of Anti-Retroviral Therapy) study. This is a management strategy study comparing two approaches to antiretroviral therapy that compares intermittent therapy based on immunologic status versus continuous therapy. This is a large, long-term study that could greatly impact on the use of antiretroviral therapy in the future.

Solid Organ Transplantation in HIV: Multi-Site Study

A multi-center study of solid organ transplantation in HIV infection is supported by the NIH. The University of Chicago is a site, and Dr. Pursell from our section is a site Co-Investigator for this trials. This study will focus on liver and renal transplantation in HIV patients as an option for organ failure. The study is designed to examine the effects of HIV on graft survival and the effects of immune suppression for the transplant on the progression of HIV disease.

Chicago Department of Public Health, Office of HIV/AIDS Surveillance

The University of Chicago is a site for the CDPH study “Estimating HIV Incidence by Using a Population-Based Serologic Method to Detect Recent HIV-1 Infection, Chicago, IL.” Previous antibody tests were only able to detect chronic HIV infection without any ability to determine if the infection was recent, having been contracted in the past 6 months to 1 year. This type of information is important in tracking the HIV epidemic and determining the efficacy of prevention measures. This study uses a de-tuned serologic test to determine if patients have had recent infection. This study will also have a component looking at the incidence of transmission of drug-resistant HIV, a growing concern for clinicians across the country.

HIV Studies

Switching HIV Patients with a Viral Load of < 50 copies/mL on a Twice Daily or More Frequent Initial HAART Regimen to a Once Daily Regimen Including Stavudine XR, Lamivudine, and Efavirenz.

Therapy for HIV has been plagued by non-compliance due to the complexity of the regimens. There has been a move to reduce the number of pills and doses, and now a number of medications have been developed as once daily drugs. However, there is little data the efficacy of regimens where all the medications are taken once a day. This study is a proof of concept study that once daily regimens can be as efficacious as regimens where medications are taken multiple times a day.

Randomized Trial of a Switch to a Kaletra (lopinavir/rit)-Containing Regimen in Patients with a Poor Immune Response to Highly Active Antiretroviral Therapy (HAART).

Not all patients who have good HIV viral suppression with highly active antiretroviral therapy (HAART) have optimal immune reconstitution. There is data that some antiretroviral agents, the protease inhibitors in particular, may be superior with respect to increasing CD4+ lymphocyte counts and reconstituting the immune system. As mechanistic part of this study, there is a laboratory component looking at the effects of Kaletra on ex vivo T cell apoptosis and intracellular viral loads in peripheral blood leukocytes. Although there are good guidelines for how to alter HIV therapy if there is inadequate viral suppression, there are no guidelines for what to do if patients have sub-optimal immune responses. We hope this trial will be a start in developing such guidelines.

HIV Screening in the Emergency Department

New CDC recommendations call for universal HIV screening. We have developed an HIV screening program that examines the predictors of HIV testing acceptance, determinants of HIV+ serostatus and utilizes an integrated approach to testing. Emergency medicine staff conduct the test and our section conducts follow-up of test results and triages patients into care with over a 99% follow-up rate.

Datpomycin in the Treatment of Infective Endocarditis or Bacteremia DThis is a study of a new antibiotic for the treatment of bacteremia, including complicated bacteremia and endocarditis, with Staph. aureus. The currently available agents are sub-optimal for this infection, and this study of the safety and efficacy may lead to a new treatment approach to manage patients with this serious infection.

Combination Antifungal Therapy for Invasive Pulmonary Aspergillosis

Invasive aspergillosis remains a disease with a high mortality rate in immunocompromised patients, despite a growing number of newer antifungal drugs available for IA. , but the outcomes with these agents are still are less than optimal. There is little data on the use of combinations of antifungal drugs for this infection, but it is an area of intense interest.

HIV, HSV-2 and other STIs in India and China

Integration of quantitative social scientific with biomedical methods advances health research beyond critical sampling biases introduced by clinic-based research and advances population-based health research beyond subjective or self-reported measures of health. We work with social science and other international collaborators to determine risk factors associated with a number of STIs as well as sub-populations that may experience HIV and STIs differently. We have worked on a large population based survey in China as well as an 8 STI clinic study to exame predictors of symptomatic and asymptomatic Chlamydia infection. We also have worked on a large population based study in South India examining how the effects of circumcision status are different for HIV and HSV-2 which is mitigated by sexual partnering patterns.

Novel HIV Prevention Strategies Amongst High Risk Men in India

An effective preventive HIV vaccine appears to be at least 15 years off. Therefore it is imperative to develop novel methods of HIV prevention amongst high-risk populations world-wide. Together with collaborators in South India, we are looking at several potential candidates for prevention including Pre-Exposure Prophylaxis, STI prevention, Circumcision and Microbicides by examining acceptability and feasibility. Several sero-epidemiologic studies are currently underway and recruiting truck-drivers, and men who have sex with men. Efforts to bring in wives of high-risk men and other female sex partners of both truck-drivers and MSM are currently underway

Antimicrobial resistance and functional status among hospitalized elderly patients.

The relationship between antimicrobial resistance (and specifically MRSA and VRE) and patrient functional status has not been rigorously examined. This study aims to determine if functional status is an independent risk for the acquisition of resistant pathogens among older hospital patients. IN additional, decline in functional status is explored as a possible outcome of colonization and infection with resistant pathogens.

Risk Factor Analysis for non-albicans Candida Infections.

Infections caused by strains of Candida that are resistant to fluconazole are on the increase. These infections cause significant morbidity and mortality, and an understanding of the risk factors is essential for the development of rational strategies for antimicrobial stewardship and transmission control

Epidemiological Analysis of VRE on a Bone Marrow Transplant Unit.

Vancomycin-resistant Enterococci (VRE) have emerged as common causes of a number of very difficult to treat infections. This is especially true for certain high-risk populations, including bone marrow transplant recipients. Research on the incidence, patterns of transmission, and effects of infection control practices are important as we try to develop new strategies to prevent these infections. Active surveillance programs offer a rich opportunity to examine the factors that govern the dissemination of VRE and other drug resistant pathogens in this population

Colonization of Mobile Computers with Pathogenic Bacteria

The deployment of a new medical informatics system at the medical center has provided a unique opportunity to examine the potential infectious threats that may emerge as new technology is deployed and clinical practices evolve. In this study, ward-based mobile computers are being periodically examined for colonization with pathogenic bacteria, including MRSA.

Ethics Research

Faculty conduct studies in medical ethics, including physician responses to utilization review, differences in the codes of ethics of medical professional associations and healthcare organizations, professionalism, and performance measures for health care ethics.