SCHOOL OF MEDICINE

Department of Medicine

Infectious Diseases Clinical Research Program

For Sponsors

The Division of Infectious Diseases at the Indiana University School of Medicine has conducted clinical trials and research to improve the health and well-being of Indiana adults and adolescents with a variety of infections for over 30 years. We specifically have performed studies in the areas of HIV/AIDS, other sexually transmitted infections (herpes, human papillomavirus, syphilis, gonorrhea, chlamydia), and sexual behavioral medicine.

Indiana University Infectious Diseases Research (IUIDR) is a research group for the Division of Infectious Diseases in the Indiana University School of Medicine. Our group also includes investigators from the Division of Adolescent Medicine and the Department of Microbiology and Immunology. The principal investigators are supported by certified research specialists, nurse practitioners, and data managers. All staff have completed training in human subject protection (CITI) and GCP training as well as biological shipment training. Our staff has experience with a variety of electronic data capture (EDC) programs.

We have experience conducting Phase I - Phase III clinical trials. For Phase I trials involving intense pharmacokinetic sampling (or other kinds of intense monitoring), the Division of Infectious Diseases Research has access to the Indiana CTSI Clinical Research Center (CRC), located on the fifth floor of University Hospital. There are 10 inpatient rooms and 14 outpatient rooms. The Indiana Clinical Research Center 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, FDA research. The equipment available on the CRC includes: EKG, glucose analyzer, IV pumps, IV syringe (BD) pumps, Dynamaps, Accu-check, pulse-ox stat, code cart, subject scales, 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.

Most of our Phase II, III trials are conducted at the Bell Flower building, first floor Fifth Third Faculty Office Building at 640 Eskenazi Avenue. 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 as well as work space for monitors. Other equipment includes a table top centrifuge and an EKG machine. We also have access to the Infectious Diseases Laboratory (about 3 blocks away) that has more sophisticated centrifuges, liquid nitrogen storage tanks and diagnostic equipment including ELISA readers and real time PCR systems.

Our research group currently conducts trials to determine the usefulness of vaccines to prevent infections and new medicines to treat existing infections such as new antiretroviral treatment for people with HIV and viral resistance, as well as studies evaluating the complications of HIV and treatment. Research studies that are open can be found here.

Research Volunteers are evaluated in the Bell Flower Clinic first floor Fifth Third Office Building at 640 Eskenazi Avenue, Indianapolis IN 46202 or at the Clinical Research Center in University Hospital at 550 N. University Blvd. Our investigators can be contacted by calling 317- 278-2945.