Division of Infectious Diseases Clinical Research Program

The infectious diseases research group, led by Samir Gupta, MD, includes investigators from the Division of Infectious Diseases, the Division of Adolescent Medicine and the Department of Microbiology and Immunology.

For more than 50 years, our researchers have conducted investigator-initiated and commercially-funded clinical trials to improve the health and well-being of Indiana adults and adolescents with a variety of infections, particularly sexually transmitted infections. Our research group has conducted trials to determine the usefulness of new medicines and vaccines to treat and prevent HIV and other sexually transmitted infections, to develop new diagnostic testing platforms for sexually transmitted infections, and to evaluate strategies to minimize long-term complications of HIV.

Participate

Study volunteers are evaluated in the Bell Flower Clinic, first floor Fifth Third Faculty Office Building at 640 Eskenazi Avenue and at the Clinical Research Center (CRC) on the fifth floor of University Hospital at 550 N. University Blvd.

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Active Research

Our team currently participates in multiple trials evaluating novel medications to treat and prevent HIV infection. In addition, we conduct trials to reduce the incidence of various long-term conditions associated with HIV, including mood disorders, cardiovascular disease, diabetes and kidney disease. We also run research studies to develop newer and faster methods to diagnose a variety of sexually transmitted infections, as well as large cohort studies to evaluate the immunology of chlamydia in men and women with the goal to develop a vaccine for this infection.

Clinical Research Support

Investigators in the Division of Infectious Diseases at IU School of Medicine have experience conducting Phase I through Phase IV clinical trials and are supported by certified research specialists, nurse practitioners and regulatory officers. All staff have completed training in human subject protection (CITI) and GCP training as well as biological shipment training. This staff has experience with a variety of electronic data capture (EDC) programs.

Indiana Clinical Research Center

For Phase I trials involving intense pharmacokinetic sampling (or other kinds of intense monitoring), the Division of Infectious Diseases has access to the Indiana CTSI Clinical Research Center, located on the fifth floor of University Hospital. This facility has highly skilled and experienced registered nurses to carry out the research protocols. An assistant nurse manager works with a staff of seven full-time RNs and a pool of hourly nurses. The nursing staff is certified in BLS, CPR, Human Subject Research, and Class A Hazardous Drug administration. Their expertise includes backgrounds in obstetrics, med/surgery, pediatrics, special diagnostics, telemetry, ER, trauma, adult ICU and FDA research. The equipment available on the CRC includes EKG, glucose analyzer, IV pumps, IV syringe (BD) pumps, Dynamaps, Accu-check, pulse-oximetry, code cart, subject scales and drug scales. CRC specimen reception provides sample processing, sample storage for up to one-week, dry ice, point of care testing, and transfer of samples to IU Health Pathology Lab.

Bell Flower Clinic

Most of our Phase II, III, and IV trials are conducted in the Bell Flower Clinic, which provides citywide care for people with and exposed to sexually transmitted infections. There are four outpatient exam rooms, a locked storage area for study medications, a series of locking cabinets and files for source documents, computers for EDC, a laboratory with monitored -80 and -20 freezers and a monitored refrigerator, and workspace for monitors. Other equipment includes a tabletop centrifuge and an EKG machine. Our team also has access to the infectious diseases laboratory (located nearby on the IU School of Medicine campus), which has more sophisticated centrifuges, liquid nitrogen storage tanks, and a variety of diagnostic equipment (including ELISA readers, multiplex platforms, and real time PCR systems).