TMC-114, new protease inhibitor for PI resistance: new 300 patient phase II study enrolling; sites listed

Articles


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: http://www.natap.org/2003/resistance/day9.htm ---------- Phase 2 study of TMC114 and low dose ritonavir in HIV-1 infected subjects This study is currently recruiting patients. Sponsored by Tibotec Pharmaceutical Purpose 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 Eligibility Ages Eligible for Study: 18 Years and above , Genders Eligible for Study: Both Criteria 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 609-730-7540 cdavis3@tibus.njn.com Alabama 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 Arizona Phoenix Body Positive, Inc.,Phoenix, Arizona, 85006, United States;Not yet recruiting Linda Sirois, RN 602-307-5330 lsirois@phoenixbodypositive.org Robert A Myers, MD, Principal Investigator California Tower ID Medical Associates,Los Angeles, California, 90048, United States;Not yet recruiting Shangri-La Jackson, LVN 310-358-2300 Ext. 114 shangrila_jackson@towerid.com 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 dmenegaz@php.ucsf.edu 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 pachorizon@earthlink.net 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 chris@marcusconantmd.com 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 chrisr@aidshealth.org 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 knuffer@ucsd.edu Richard Haubrich, MD, Principal Investigator Living Hope Clinical Foundation,Long Beach, California, 90813, United States;Not yet recruiting Robert Cordova, RN 562-624-4943 rxcordova@chw.edu Stefan Schneider, MD, Principal Investigator University of Southern California,Los Angeles, California, 90033, United States;Not yet recruiting Luis Mendez 323-343-8288 lmendez@usc.edu 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 jbautist@pacificoaks.com Peter Wolfe, MD, Principal Investigator Colorado University of Colorado Health Sciences Center,Denver, Colorado, 80262, United States;Not yet recruiting Beverly Putnam, RN 303-372-5537 beverly.putnam@uchsc.edu 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 cgeisler@wwc.org Phillippe Chiliade, MD, Principal Investigator Capital Medical Associates, PC,Washington, District of Columbia, 20036, United States;Recruiting Alex Seymour 202-822-6311 alex@dcdocs.com 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 sschuck@mfa.gwu.edu Gary Simon, MD, Principal Investigator Florida 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 doreengarabedian@aol.com Jose Hernandez, MD, Principal Investigator Therafirst Medical Centers,Fort Lauderdale, Florida, 33308, United States;Recruiting Helena M Kosters 954-564-4222 Ext. 207 helena@therafirst.com Anthony LaMarca, MD, Principal Investigator Clinical Research Center at Tampa,Tampa, Florida, 33606, United States;Not yet recruiting Anne Howley 813-844-4639 ahowley@tgh.org Jeffrey Nadler, MD, Principal Investigator Treasure Coast Infectious Disease Consultants,Vero Beach, Florida, 32960, United States;Recruiting Jeff Mieras, RN 772-978-9556 jeffm@cmamed.com 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 hyontef@nbhd.org Michael Sension, MD, Principal Investigator Steinhart Medical Associates,Miami, Florida, 33133, United States;Recruiting Amy Sue Liebmann, LPN 305-856-2171 Ext. 232 aliebmann@aol.com Corklin Steinhart, MD, Principal Investigator Infectious Disease Research Institute, Inc.,Tampa, Florida, 33614, United States;Not yet recruiting Kalliope Halkias, MPH 813-875-4374 kdhalkias@idrifla.com Bienvenido Yangco, MD, Principal Investigator Georgia Mercer University School of Medicine,Macon, Georgia, 31201, United States;Not yet recruiting Sophia James, RN 478-301-5837 james_sw@mercer.edu Harold Katner, MD, Principal Investigator Grady Infectious Disease Program,Atlanta, Georgia, 30308, United States;Not yet recruiting Ericka Patrick, RN 404-616-6313 erpatri@emory.edu Jeffrey Lennox, MD, Principal Investigator Atlanta Specialty Research,Atlanta, Georgia, 30342, United States;Not yet recruiting Jenny L Usherwood, PA-C 404-459-0002 jusherwood@mindspring.com Steven Marlowe, MD, Principal Investigator Illinois Northstar Medical Center,Chicago, Illinois, 60657, United States;Recruiting Harriett Wittert, RN 773-296-2400 Ext. 122 harriettw@nstarmedical.com Daniel Berger, MD, Principal Investigator Northwestern University,Chicago, Illinois, 60611, United States;Not yet recruiting Patrick Milne 312-695-5045 patrick@northwestern.edu Robert L Murphy, MD, Principal Investigator Maryland Johns Hopkins University School of Medicine,Baltimore, Maryland, 21287, United States;Not yet recruiting Michelle Parish, RN 410-614-1338 maparish@jhmi.edu Joel Gallant, MD, Principal Investigator Massachusetts 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 lpope@crine.org James A Hellinger, MD, Principal Investigator Massachusetts General Hospital,Boston, Massachusetts, 02114, United States;Not yet recruiting Theresa Flynn, RN 617-726-3819 tflynn@partners.org 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 amorris@crine.org Anne B Morris, MD, Principal Investigator Minnesota University of Minnesota,Minneapolis, Minnesota, 55404, United States;Not yet recruiting Joann Armstrong, RN 612-863-5241 joann.armstrong@allina.com 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 mc675@columbia.edu 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 ahurley@adarc.org Martin Markowitz, MD, Principal Investigator Albany Medical College,Albany, New York, 12208, United States;Not yet recruiting Sandra Preston, Pharm.D. 518-262-6330 prestos@mail.amc.edu 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 va9001@nyp.org 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 cjm@med.unc.edu Joseph Eron, MD, Principal Investigator Jemsek Clinic,Huntersville, North Carolina, 28078, United States;Not yet recruiting Paula Hutcherson, RN 704-987-2111 ph@jemsekclinic.com Joseph Jemsek, MD, Principal Investigator Ohio University of Cincinnati,Cincinnati, Ohio, 45267-0405, United States;Not yet recruiting Tammy Powell, RN 513-584-8373 powelltm@ucmail.uc.edu Judith Feinberg, MD, Principal Investigator Case Western Reserve University,Cleveland, Ohio, 44106, United States;Not yet recruiting Michael Chance, RN 216-844-8051 chance.michael@clevelandactu.org Robert Salata, MD, Principal Investigator Pennsylvania University of Pennsylvania Medical Center,Philadelphia, Pennsylvania, 19104-6073, United States;Not yet recruiting Ruth Brower 215-615-0122 ruth.brower@uphs.upenn.edu Ian Frank, MD, Principal Investigator University of Pittsburgh,Pittsburgh, Pennsylvania, 15213, United States;Not yet recruiting Barbara Rutecki, MSN 412-647-8116 ruteckibm@upmc.edu Deborah McMahon, MD, Principal Investigator Division of Infectious Diseases,Hershey, Pennsylvania, 17033, United States;Not yet recruiting Mary Catherine Hess 717-531-3721 mhess@psu.edu John Zurlo, MD, Principal Investigator South Carolina The Burnside Clinic,Columbia, South Carolina, 29206, United States;Not yet recruiting John Windham 803-787-1113 john@burnsideclinic.com Alfred Burnside, MD, Principal Investigator Texas University of Texas Health Sciences Center at Houston,Houston, Texas, 77030, United States;Not yet recruiting Raul Nunez 713-500-5483 raul.nunez@uth.tmc.edu Ben Barnett, MD, Principal Investigator Southwest Infectious Disease Associates,Dallas, Texas, 75246, United States;Not yet recruiting Brenda Gusters, CCRC 214-828-4702 bgusters@drbellos.com 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 joseph.cheatum@airmail.net 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 chip.lohner@utsouthwestern.edu 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 clmogrid@utmb.edu William O'Brien, MD, Principal Investigator Virginia Hampton Roads Medical Specialists,Hampton, Virginia, 23666, United States;Not yet recruiting Katy Scwarzenberger-Lego 757-838-8677 Ext. 15 hrms2112@netzero.com Stephen Green, MD, Principal Investigator Washington 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 njc@u.washington.edu Ann Collier, MD, Principal Investigator Swedish Medical Center,Seattle, Washington, 98122, United States;Not yet recruiting Heather Algren, RN 206-386-2820 heather.algren@swedish.org Peter Shalit, MD, Principal Investigator Wisconsin Froedtert and Medical College Infectious Disease Clinic,Milwaukee, Wisconsin, 53226, United States;Not yet recruiting Julie Raaum, APNP 414-456-7003 jraaum@mcw.edu 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 gastro_de_diego@wns.net Veronica Perez, MD, Principal Investigator Obstetrics and Gynecology Department,San Juan, 00936-5067, Puerto Rico;Not yet recruiting Georgamaly Estronza 787-753-5913 gestronza@rcm.upr.edu Carmen Zorrilla, MD, Principal Investigator

View Older Articles

Back to Top

www.natap.org