Daniel Berger

Dr. Daniel Berger (born November 25, 1957) is a leading HIV specialist in the United States. A Clinical Associate Professor at the Chicago campus of the University of Illinois College of Medicine, Berger is also founder and medical director of Northstar Medical Center, Chicago’s largest private HIV research and treatment center.

Berger has received numerous awards for his work as a researcher and teacher, including the Charles E. Clifton Leadership Award “For excellence and leadership to the Chicago HIV community” (2006), the Distinguished Researcher in HIV Medicine Award from Serono Laboratories (2000) and the American College of Physicians’ Preceptor Award for outstanding teaching in internal medicine (1996).

Born in Brooklyn, New York, Berger received his B.S. from Touro College in New York City and his M.D. from Rosalind Franklin University of Medicine and Science (The Chicago Medical School North Chicago). He interned at Lutheran General Hospital of Park Ridge, Illinois and completed his residency at Saint Joseph Hospital of Chicago, Illinois.

In addition to his medical and research practices, Berger is an avid collector of Outsider Art and contemporary art, with a specialization in works by African-American, Chicago based and queer artists. In 2010, he opened Iceberg Projects, a not-for-profit art gallery, in a refurbished carriage house behind his home in Chicago’s Rogers Park neighborhood.

HIV research

At Northstar Medical Center, where he serves as principal investigator, Berger has conducted nearly 200 HIV-related clinical trials. Well known in the antiretroviral drug research and development community, Berger has published dozens of articles in peer-reviewed medical journals and authored abstracts in many international conferences on HIV-related treatment.

During the first years of HIV treatment development, Berger presented his work on several watershed studies on the development of the drug cocktail. Highlights include a presentation at the 1992 International AIDS Conference describing the first use of combination therapy with zidovudine and didanosine for patients who were consistently p24 anti-genemic despite zidovudine monotherapy. Also, Berger conducted the first investigations of interleukin II in advanced HIV disease patients, presented at the 1998 International Conference on AIDS.

During the years 2005-2010, antiretroviral therapy for HIV disease experienced a revolution in therapeutics. Berger was heavily involved as principle investigator of these agents and co-authored several resultant iconic publications of trials including the Power 2, Titan, Duet and Startmrk studies and the first studies of elvitegravir. Berger often lectures to physicians around the US on topics relating to incorporating of newer antiretroviral therapies into treatment. Additionally, Berger frequently publishes editorial articles in the lay press.

FDA trial difficulties and successful resolution of NIDPO

In 2008, an employee of Northstar Medical, without knowledge of Berger or his sub-investigators, falsified some results in one drug trial. Subsequent investigation uncovered extensive evidence of criminality in the individual’s past, including embezzlement from Chicago’s DePaul University (which became the grounds for a criminal case). This resulted in a U.S. Food and Drug Administration (FDA) review of Berger’s participation in the trial, and a Notice of Initiation of Disqualification Procedure and Opportunity to Explain (NIDPO).

Eventually, after extensive FDA review, Berger was cleared of all wrongdoing and allowed to continue his research work with minimal supervision by an independent monitor and without any other restrictions. Berger is currently (2011) serving as principal investigator in multiple studies.

Selected references

Raltegravir Versus Efavirenz Regimens in Treatment-Naïve HIV-1-Infected Patients: 96-Week Efficacy, Durability, Subgroup, Safety, and Metabolic Analysis. Jeffrey L. Lennox, Edwin DeJesus, Daniel S. Berger, Adriano Lazzarin, Richard B. Pollard, Jose Valdez Ramalho Madruga, Jing Zhao, Hong Wan, Christopher L Gilbert, Hedy Teppler, Anthony J. Rodgers, Richard J.O. Barnard, Michael D. Miller, Mark J. DiNubile, Bach-Yen Nguyen, Randi Leavitt, Peter Sklar for the STARTMRK Investigators. J Acquir Immune Defic Syndr. 2010. doi: 10.1097/QAI.0b013e3181da1287

Activity of Elvitegravir, a Once-Daily Integrase Inhibitor, against Resistant HIV Type 1: Results of a Phase 2, Randomized, Controlled, Dose-Ranging Clinical Trial. Andrew R. Zolopa, Daniel S. Berger, Harry Lampiris, Lijie Zhong, Steven L. Chuck, Jeffrey V. Enejosa, Brian P. Kearney, and Andrew Cheng. JID 2010;201:814-22.

Metabolic Effects of a Growth Hormone-Releasing Factor in Patients with HIV. Julian Falutz, Soraya Allas, Koenraad Blot, Diane Potvin, Donald Kotler, Michael Somero, Daniel Berger, Stephen Brown, Gary Richmond, Jeffrey Fessel, Ralph Turner and Steven Grinspoon. New Engl J Med 2007;357:2359-70.

A Randomized, Controlled Phase III Trial Compariing 48-week Efficacy and Safety of Darunavir/Ritonavir (DRV/r) with Lopinavir/Ritonavir (LPV/r) in treatment experienced patients: TITAN. JoseValdez-Madruga, Daniel Berger, Marilyn McMurchie, Fredy Suter, Denes Banhegyi, Dorece Norris, Eric Lefebvre, Tony Vangeneugden, Marie-Pierre de Bethune, Frank Tomaka, Martine De Pauw , Sabrina Spinosa-Guzman. The Lancet 2007; 370:49-58

Week 24 Efficacy and Safety of TMC114/ritonavir in treatment-experienced HIV Patients: R Haubrich, D. Berger, P Chilade, A Colson, M Conant, J Gallant, R Gulick, J Nadler, G Pierone, M Saag, P Shalit, B van Baelen M de Bethune, A Koest er, W Parys, V Sekar, E Lefebvre on behalf of Power 2 study group AIDS 2007, 21:F11-F18.

External links

• http://www.nstarmedical.com/
• http://www.natap.org/2010/newsUpdates/091610_01.htm
• http://www.thelancet.com/journals/lancet/article/PIIS0140673607610496/fulltext
• http://www.medscape.com/viewarticle/735387
• http://hivinsite.ucsf.edu/InSite-KB-ref.jsp?page=ar-03-10&rf=2
• http://hivinsite.ucsf.edu/InSite-KB-ref.jsp?page=ar-03-10&rf=2
• http://jid.oxfordjournals.org/content/201/6/814.full
• http://icebergchicago.com/home.html