The Georgetown University Hospital Division of Infectious Diseases Clinical Trials Unit mission is:
- To participate in clinical studies that focus on the development of new anti-infective agents, including antiretroviral therapy.
- To perform epidemiological studies that help better understand the natural history of a specific infection such as HIV.
- To perform epidemiological studies that identify new problems associated with an infectious disease or to investigate new trends in antimicrobial resistance.
- To perform clinical trials that serve our patient population by offering them promising therapies that would not be available elsewhere.
The GUH-ID Clinical Trials Unit (CTU) has had a distinguished track record in the area of HIV/AIDS clinical research. The CTU was funded as a primary AIDS Clinical Trials Unit (ACTU) from 1991–1995, and is currently a Clinical Research Site (CRS) of the University of Pittsburgh ACTU. The Adult AIDS Clinical Trials Group (AACTG) is an NIAID funded clinical trials network that focuses on the development of new agents, and new treatment strategies for persons infected with HIV. The CTU is the only AACTU site in the greater metropolitan Washington, DC area. The CTU has been a site for the NHLBI sponsored Viral Activation Transfusion Study (VATS) (1&2) and is currently a major site for the NIAID sponsored Women’s Intra-Agency HIV Study (WIHS) since 1993. Since 1999, the GUH-ID CTU has opened more than 60 AACTG and industry sponsored HIV/AIDS clinical trials.
The research staff has participated in new HIV drug treatment trials in all phases of drug development including Phase I and Pharmacokinetic trials. The CTU also has access to a NIH funded General Clinical Research Center (GCRC) which has the capabilities to perform 24 hour PK studies and overnight stays if required by a protocol. The GCRC has been instrumental in assisting the CTU with Phase I and drug interaction studies.
Dr. Princy Kumar, the site PI for the AACTU, has been involved in HIV clinical research since 1990, and has successfully collaborated with the Pharmaceutical industry in both early stage drug development and late stage (Phase IV) drug development. Dr. Kumar has been a site investigator for 60 clinical research trials. Of note, she has been the site PI for the Phase I/II study of abacavir (3), the drug interaction studies for clarithromycin/rifabutin and azithromycin/rifabutin(4,5), the dose ranging study for tipranavir , the Phase II study of the CCR5 inhibitor (GW873140) (6) and the Phase II study of the Merck Integrase Inhibitor(L000900612). She has also been a site investigator for numerous Phase III and IV HIV/AIDS treatment trials, and is currently the national PI for a multicenter trial comparing Trizivir versus Combivir + Reyataz in antiretroviral naïve HIV infected subjects (ESS100327). Additionally, she has contributed to the understanding of hyperlipidemia in HIV infected patients receiving HAART (7). As a result of her HIV clinical trials experience, she has been a member and consultant to the Antiviral Advisory Panel of the Food and Drug Administration (FDA). In addition to being the site PI, she has served on the Adult ACTG Forms Committee, and has made major contributions towards the development of the cross protocol Case Report Forms. She has previously been a member of the Viral Pathogens Study Group of the ACTG.
Dr. Joseph Timpone is the CTU co-PI, and also has extensive experience in the design and management of HIV/AIDS clinical trials. From 1991-1993, he served as a medical officer at the Division of AIDS in the Antiretroviral Treatment Research Section, where he contributed to the development and design of numerous Adult ACTG trials including: ACTG 162, ACTG 199(8),ACTG 201(9), ACTG 229(10), ACTG 231 (11), ACTG 241 (12), ACTG 242, ACTG 243(13), and DATRI 004 (14). He served as the medical officer liaison to the Combination Therapies Working Group, the Neurology Core Committee, and the Pharmacology Core Committee of the ACTG. Dr. Timpone also has experience in the design of HIV drug interaction trials (11,13, 15). From 1993 –’95, he served as the site PI for the Georgetown ACTU sub-site at D.C. General Hospital. Since 2001, he has served as a protocol team member for A5135(a therapeutic drug monitoring study) and A5202(a Phase IV study comparing Tenofovir/FTC + Efavirenz vs. abacavir/3TC+efavirenz vs. Tenofovir/FTC+Atazanavir/Ritonavir vs. abacavir/3TC+atazanavir/ritonavir in antiretroviral naïve HIV infected subjects). He was also a member of the Antiretroviral Naïve Focus Group, from which the trial design of A5202 originated. He has presented and published work on some of the metabolic complications associated with HIV – specifically, avascular necrosis, and reduced bone mineral density (16, 17, 18). Dr. Timpone was also a site investigator for the N.I.A.I.D. sponsored protocol Solid Organ Transplantation in HIV: Multi-site Study.
Dr. Mary Young is the PI for the WIHS cohort in Washington D.C., and has enrolled and followed 400 women (300 HIV infected, 100 controls) for a median follow-up of 11 years. Dr. Young has made scientific contributions to all aspects of WIHS, which boasts greater than 250 publications in peer reviewed journals (19 -23). She is currently chairperson of the Neurocognition and Aging Working Group, and has been the site PI for numerous WIHS protocols. Most recently, she has been the site PI for the Carotid Artery Intimal Thickness study to evaluate the predictors of cardiovascular morbidity and mortality in HIV infected women and the Virologic Rebound and Resistance Study to correlate drug exposure (using 12 hour PK sampling) and assess risk of virologic failure in HIV infected women. She is initiating a study entitled “Sleep, Fatigue and the Interrelationship with HIV/AIDS” in collaboration with investigators at Johns Hopkins. She also sits on the Mayor’s Advisory Council on AIDS.
Dr. Gayle Balba is a junior faculty member who is the site PI for A5178 (SLAM C Study) which is evaluating a prolonged treatment regimen of Interferon and Ribavirin in HIV infected subjects co-infected with hepatitis C. She is a member of the HIV/Hepatitis C Co-infection Working Group in the WIHS