Looking Ahead

The Georgetown University Hospital Division of Infectious Diseases Clinical Trials Unit (GUH-ID CTU) will continue to develop and participate in clinical studies that fulfill its research agenda and serve the patient population it cares for. Shortly after the widespread availability of potent antiretroviral combination therapy, the investigators at GUH recognized that virologic failure was relatively common in their urban –based patient population. As a result, the investigators at GUH made new antiretroviral drug development with alternative mechanisms of action, and different resistance pathways a high priority of their research agenda. The GUH-CTU has been responsible for the initial PK data for abacavir (3), and contributed to the dose finding study for tipranaavir which has recently been approved by the FDA. The GUH-CTU has a proven track record for implementing protocols that study new antiretroviral agents during early phases of drug development. The investigators at the GUH-CTU have collaborated closely with the pharmaceutical industry and have both implemented protocols and provided consultation on drug development. During thee past 10 years, the investigators have partnered with Glaxo Smith Kline, merck, Abbott, Bristol Myers Squibb, Gilead, Hoffmann-LaRoche, and Boehringer Ingelheim.

CCR5 Entry Inhibitors: The site leader, Dr. Kumar has focused most of her research efforts on early phase drug development of novel antiretroviral compounds that inhibit new targets of HIV replication. She has been an investigator for the early PK and activity study for the CCR5 entry inhibitor GW873140, which has been accepted for publication(6). Dr. Timpone is the site investigator for A5211, which is evaluating the activity of the CCR5 entry inhibitor SCH-417690, and has been successful in enrolling patients into this study.

Integrase Inhibitors:In an effort to expand their menu of novel agents, Dr. Kumar has been studying the Merck Integrase Inhibitor(L000900612). This compound has now been advanced to a Phase III study which is currently open here at the GUH-CTU.

The GUH-CTU investigators are dedicated to studying agents that have different resistance profiles as many patients in the clinic are complicated referrals who have failed multiple regimens. Dr. Kumar has participated in the clinical trials that established the resistance profile of tipranavir. Dr. Kumar is also involved in a Phase IIB dose finding study of GW640385/ritonavir, a novel protease inhibitor with a unique resistance profile. She is also the site PI of the Phase IIB study of GW695634, a next generation non-nucleoside reverse transcriptase inhibitor (NNRTI) which does not have cross resistance with the currently available NNRTIs. The GUH-CTU is currently participating in these studies.

For more information, please contact the GUH-CTU at 202 687-1079.