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TMC-114, new protease inhibitor for PI resistance: new 300 patient phase II study enrolling; sites listed
  Reported by Jules Levin
TMC-114 is a new protease inhibitor just completing early stages of development that is intended to be used by patients who have resistance to the currently available protease inhibitors, and the drug appears to be promising for patients who are resistant to currently available protease inhibitors.
This protease inhibitor has been shown in in vitro or laboratory studies to be potent against HIV with PI resistance. In a 14-day study TMC-114 reduced viral load an average of -1.35 log in patients with experience and resistance with multiple protease inhibitors. This new phase II study is a 48-week study that will test the drug in 300 patients with PI resistance. You can read more about TMC-114 and previous study results at this link:
Phase 2 study of TMC114 and low dose ritonavir in HIV-1 infected subjects
This study is currently recruiting patients.
Sponsored by Tibotec Pharmaceutical
The purpose of this study is to determine the effectiveness, safety, and tolerability (how well the body stands the drug) of an investigational protease inhibitor (PI) called TMC114 given with low dose ritonavir. Subjects who have previously received all three licensed classes of HIV antiviral drugs (known as nucleoside reverse transcriptase inhibitors (NRTI), nonnucleoside reverse transcriptase inhibitors (NNRTI) and protease inhibitors (PI)), and who are on a stable PI-containing regimen not including an NNRTI may be eligible to participate. Four doses of TMC-114/ritonavir will be studied. 300 patients in the United States and Puerto Rico will participate. The duration of the study is 48 weeks.
  MEDLINEplus related topics: AIDS
Study Type: Interventional
Study Design: Treatment, Randomized, Safety/Efficacy Study
Official Title: A Phase II randomized, controlled, partially blinded, 48-week trial to investigate dose response of TMC114/RTV in 3 class-experienced, multi PI-experienced HIV-1 infected subjects
Ages Eligible for Study: 18 Years and above , Genders Eligible for Study: Both
Major Inclusion Criteria
  • Male or female, age 18 years or older.
  • Documented HIV-1 infection.
  • Stable PI regimen for at least 8 weeks prior to screening.
  • Plasma viral load at screening above 1000 HIV-1 RNA copies/ml.
  • Prior use of more than 1 NRTI for at least 3 months.
  • Prior use of one or more NNRTIs as part of a failing regimen.
  • At least 1 primary PI mutation as defined by the IAS guidelines.
  • Treatment with at least two different PIs for a total of at least 3 months.
  • Suject has given informed consent.
Major Exclusion Criteria
  • Presence of any currently active AIDS defining illness except stable cutaneous Kaposi's Sarcoma and Wasting syndrome due to HIV infection.
  • Current or past history of alcohol and/or drug abuse which, in the investigator's opinion, would compromise the subject's safety or compliance to the study protocol procedures.
  • NNRTI as part of therapy at screening.
  • Patients on a treatment interruption at screening.
  • Patients for whom an investigational antiretroviral therapy is part of the regimen at screening or the use of any non-antiretroviral investigational agents 90 days prior to screening.
  • Hepatitis A, B, or C.
Expected Total Enrollment: 300
Location and Contact Information
Carol A Davis, BA

University of Alabama at Birmingham,Birmingham, Alabama, 35294-2050, United States;Not yet recruiting
Karen Savage, RN 205-975-7925 kgsavage@uab.edu
Michael Saag, MD, Principal Investigator

Phoenix Body Positive, Inc.,Phoenix, Arizona, 85006, United States;Not yet recruiting
Linda Sirois, RN 602-307-5330
Robert A Myers, MD, Principal Investigator
Tower ID Medical Associates,Los Angeles, California, 90048, United States;Not yet recruiting
Shangri-La Jackson, LVN 310-358-2300 Ext. 114
David Anderson, MD, Principal Investigator
University of California San Francisco,San Francisco, California, 94110, United States;Not yet recruiting
Dean Menegaz 415-476-9296 Ext. 336
George Beatty, MD, Principal Investigator
Pacific Horizon Medical Group, Inc.,San Francisco, California, 94115, United States;Not yet recruiting
Amber Orr, CRC 415-292-5477 Ext. 481
Stephen Becker, MD, Principal Investigator
Research Unit of Marcus Conant, MD,San Francisco, California, 94114, United States;Not yet recruiting
Christopher L Eden, MD 415-255-0744
Marcus Conant, MD, Principal Investigator
AIDS Healthcare Foundation Research Center,Los Angeles, California, 90015, United States;Not yet recruiting
Chris Rice, RN 323-913-1033
Charles Farthing, MD, Principal Investigator
University of California, San Diego,San Diego, California, 92103, United States;Not yet recruiting
Kathy Nuffer, FNP 619-543-8080
Richard Haubrich, MD, Principal Investigator
Living Hope Clinical Foundation,Long Beach, California, 90813, United States;Not yet recruiting
Robert Cordova, RN 562-624-4943
Stefan Schneider, MD, Principal Investigator
University of Southern California,Los Angeles, California, 90033, United States;Not yet recruiting
Luis Mendez 323-343-8288
Kate Squires, MD, Principal Investigator
Pacific Oaks Research,Beverly Hills, California, 90211, United States;Not yet recruiting
Joy Bautista, RN 310-652-8729 Ext. 3517
Peter Wolfe, MD, Principal Investigator
University of Colorado Health Sciences Center,Denver, Colorado, 80262, United States;Not yet recruiting
Beverly Putnam, RN 303-372-5537
Robert Schooley, MD, Principal Investigator
District of Columbia
Whitman-Walker Clinic,Washington, District of Columbia, 20009, United States;Not yet recruiting
Christiane Geisler, RN 202-745-6150
Phillippe Chiliade, MD, Principal Investigator
Capital Medical Associates, PC,Washington, District of Columbia, 20036, United States;Recruiting
Alex Seymour 202-822-6311
Bruce Rashbaum, MD, Principal Investigator
George Washington University Medical Center,Washington, District of Columbia, 20037, United States;Not yet recruiting
Suzanne Schuck, RN 202-741-2439
Gary Simon, MD, Principal Investigator
IDC Research Initiative,Altamonte Springs, Florida, 32701, United States;Recruiting
Joy Edwards, RN 407-647-3960 Ext. 3104
jgallagherOidcri@earthlink.net and cc: idcresearch@earthlink.net
Edwin DeJesus, MD, Principal Investigator
South Beach Medical Associates,Miami Beach, Florida, 33139, United States;Not yet recruiting
Doreen Garabedian 305-695-1300
Jose Hernandez, MD, Principal Investigator
Therafirst Medical Centers,Fort Lauderdale, Florida, 33308, United States;Recruiting
Helena M Kosters 954-564-4222 Ext. 207
Anthony LaMarca, MD, Principal Investigator
Clinical Research Center at Tampa,Tampa, Florida, 33606, United States;Not yet recruiting
Anne Howley 813-844-4639
Jeffrey Nadler, MD, Principal Investigator
Treasure Coast Infectious Disease Consultants,Vero Beach, Florida, 32960, United States;Recruiting
Jeff Mieras, RN 772-978-9556
Gerald Pierone, MD, Principal Investigator
HIV Clinical Research,Ft. Lauderdale, Florida, 33311, United States;Not yet recruiting
Howard Yontef, RN 954-467-3006 Ext. 224
Michael Sension, MD, Principal Investigator
Steinhart Medical Associates,Miami, Florida, 33133, United States;Recruiting
Amy Sue Liebmann, LPN 305-856-2171 Ext. 232
Corklin Steinhart, MD, Principal Investigator
Infectious Disease Research Institute, Inc.,Tampa, Florida, 33614, United States;Not yet recruiting
Kalliope Halkias, MPH 813-875-4374
Bienvenido Yangco, MD, Principal Investigator
Mercer University School of Medicine,Macon, Georgia, 31201, United States;Not yet recruiting
Sophia James, RN 478-301-5837
Harold Katner, MD, Principal Investigator
Grady Infectious Disease Program,Atlanta, Georgia, 30308, United States;Not yet recruiting
Ericka Patrick, RN 404-616-6313
Jeffrey Lennox, MD, Principal Investigator
Atlanta Specialty Research,Atlanta, Georgia, 30342, United States;Not yet recruiting
Jenny L Usherwood, PA-C 404-459-0002
Steven Marlowe, MD, Principal Investigator
Northstar Medical Center,Chicago, Illinois, 60657, United States;Recruiting
Harriett Wittert, RN 773-296-2400 Ext. 122
Daniel Berger, MD, Principal Investigator
Northwestern University,Chicago, Illinois, 60611, United States;Not yet recruiting
Patrick Milne 312-695-5045
Robert L Murphy, MD, Principal Investigator
Johns Hopkins University School of Medicine,Baltimore, Maryland, 21287, United States;Not yet recruiting
Michelle Parish, RN 410-614-1338
Joel Gallant, MD, Principal Investigator
Community Research Initiative of New England - Boston,Boston, Massachusetts, 02215-3318, United States;Not yet recruiting
Lenore Jackson-Pope, RN 617-778-5454 Ext. 223
James A Hellinger, MD, Principal Investigator
Massachusetts General Hospital,Boston, Massachusetts, 02114, United States;Not yet recruiting
Theresa Flynn, RN 617-726-3819
Daniel Kuritzkes, MD, Principal Investigator
Community Research Initiative of New England - Springfield,Springfield, Massachusetts, 01107-1635, United States;Not yet recruiting
Anne B Morris, MD 413-734-2264
Anne B Morris, MD, Principal Investigator
University of Minnesota,Minneapolis, Minnesota, 55404, United States;Not yet recruiting
Joann Armstrong, RN 612-863-5241
Frank Rhame, MD, Principal Investigator
New York
Columbia University - College of Physicians and Surgeons,New York, New York, 10032, United States;Not yet recruiting
Mykyelle Crawford, RN 212-305-2665
Scott Hammer, MD, Principal Investigator
The Rockefeller University Hospital,New York, New York, 10021, United States;Not yet recruiting
Arlene Hurley, RN 212-448-5020
Martin Markowitz, MD, Principal Investigator
Albany Medical College,Albany, New York, 12208, United States;Not yet recruiting
Sandra Preston, Pharm.D. 518-262-6330
Peter Piliero, MD, Principal Investigator
Cornell Clinical Trials Unit,New York, New York, 10021, United States;Not yet recruiting
Valery Hughes, FNP 212-746-4393
Timothy Wilkin, MD, Principal Investigator
North Carolina
University of North Carolina at Chapel Hill,Chapel Hill, North Carolina, 27516-7215, United States;Not yet recruiting
Cheryl Marcus 919-843-8761
Joseph Eron, MD, Principal Investigator
Jemsek Clinic,Huntersville, North Carolina, 28078, United States;Not yet recruiting
Paula Hutcherson, RN 704-987-2111
Joseph Jemsek, MD, Principal Investigator
University of Cincinnati,Cincinnati, Ohio, 45267-0405, United States;Not yet recruiting
Tammy Powell, RN 513-584-8373
Judith Feinberg, MD, Principal Investigator
Case Western Reserve University,Cleveland, Ohio, 44106, United States;Not yet recruiting
Michael Chance, RN 216-844-8051
Robert Salata, MD, Principal Investigator
University of Pennsylvania Medical Center,Philadelphia, Pennsylvania, 19104-6073, United States;Not yet recruiting
Ruth Brower 215-615-0122
Ian Frank, MD, Principal Investigator
University of Pittsburgh,Pittsburgh, Pennsylvania, 15213, United States;Not yet recruiting
Barbara Rutecki, MSN 412-647-8116
Deborah McMahon, MD, Principal Investigator
Division of Infectious Diseases,Hershey, Pennsylvania, 17033, United States;Not yet recruiting
Mary Catherine Hess 717-531-3721
John Zurlo, MD, Principal Investigator
South Carolina
The Burnside Clinic,Columbia, South Carolina, 29206, United States;Not yet recruiting
John Windham 803-787-1113
Alfred Burnside, MD, Principal Investigator
University of Texas Health Sciences Center at Houston,Houston, Texas, 77030, United States;Not yet recruiting
Raul Nunez 713-500-5483
Ben Barnett, MD, Principal Investigator
Southwest Infectious Disease Associates,Dallas, Texas, 75246, United States;Not yet recruiting
Brenda Gusters, CCRC 214-828-4702
Nicholaos C Bellos, MD, Principal Investigator
North Texas Center for AIDS and Clinical Research,Dallas, Texas, 75208, United States;Not yet recruiting
Joseph Cheatum, CRC 214-941-4000 Ext. 18
David Brand, MD, Principal Investigator
The University of Texas Southwestern Medical Center at Dallas,Dallas, Texas, 75235-9173, United States;Not yet recruiting
Chip Lohner 214-590-0414
Philip Keiser, MD, Principal Investigator
University of Texas Medical Branch,Galveston, Texas, 77555-0435, United States;Not yet recruiting
Cheryl Mogridge, RN 409-772-3991
William O'Brien, MD, Principal Investigator
Hampton Roads Medical Specialists,Hampton, Virginia, 23666, United States;Not yet recruiting
Katy Scwarzenberger-Lego 757-838-8677 Ext. 15
Stephen Green, MD, Principal Investigator
UW AIDS Clinical Trials Unit - University of Washington School of Medicine,Seattle, Washington, 98104, United States;Not yet recruiting
Jeanne Conley, RN 206-731-8877
Ann Collier, MD, Principal Investigator
Swedish Medical Center,Seattle, Washington, 98122, United States;Not yet recruiting
Heather Algren, RN 206-386-2820
Peter Shalit, MD, Principal Investigator
Froedtert and Medical College Infectious Disease Clinic,Milwaukee, Wisconsin, 53226, United States;Not yet recruiting
Julie Raaum, APNP 414-456-7003
Michael Frank, MD, Principal Investigator
Puerto Rico
Fundacion de Investigacion de Diego,San Juan, 00909, Puerto Rico;Not yet recruiting
Edgardo Aponte, RN 787-722-1248
Veronica Perez, MD, Principal Investigator
Obstetrics and Gynecology Department,San Juan, 00936-5067, Puerto Rico;Not yet recruiting
Georgamaly Estronza 787-753-5913
Carmen Zorrilla, MD, Principal Investigator
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