Guest guest Posted May 26, 2005 Report Share Posted May 26, 2005 NATAP - http://www.natap.org Trial of TMC114 Administered with Low Dose Ritonavir (RTV) in HIV-1 Infected Treatment Experienced Patients clinicaltrials.gov Study TMC114-C214 is a randomized, controlled, open-label trial to compare the efficacy, safety and tolerability of TMC114 boosted with low dose ritonavir (RTV) versus lopinavir (LPV)/RTV in treatment-experienced HIV-1 infected patients. Primary Outcomes: Change in viral load at 48 weeks. Secondary Outcomes: Evaluate safety, tolerability and durability of efficacy over 96 weeks. Expected Total Enrollment: 500 Study start: April 2005; Expected completion: March 2008 Last follow-up: November 2007; Data entry closure: December 2007 Study TMC114-C214 is a randomized, controlled, open-label trial to compare the efficacy, safety and tolerability of TMC114 boosted with low dose ritonavir (RTV) versus lopinavir (LPV)/RTV in treatment-experienced HIV-1 infected patients. This research study will look at the safety of TMC114 and its effectiveness in reducing the amount of HIV (viral load) in the blood. People included in this study will have received either Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) or Protease Inhibitors (PIs) or both. Major inclusion and exclusion criteria are listed below. The duration of the study will be approximately 106 weeks, which includes a 4 to 6 week screening period, 96-week treatment period, and 4-week follow-up period. Eligibility Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both Criteria Inclusion Criteria: * Patient has documented HIV-1 infection * Treatment with an Antiretroviral regimen (containing at least 2 NRTIs in combination with at least 1 NNRTI and/or 1 PI) for at least 12 weeks * Plasma HIV-1 RNA >1000 copies/mL * General medical condition does not interfere with the assessments and the completion of the trial Exclusion Criteria: * Patients for whom an investigational Antiretroviral is part of the current regimen, with the following exceptions if applicable (depending on local regulatory approval); tenofovir, emtricitabine, atazanavir, fosamprenavir * Previous or current use of lopinavir, enfuvirtide (T-20), tipranavir and TMC114 * Life expectancy of less than 6 months * Pregnant or breast-feeding * Females of childbearing potential not willing to use effective non-hormonal birth control methods or not willing to continue practicing these birth control methods for at least 14 days after the end of the treatment period * Patients with significantly decreased liver function or decompensation, irrespective of liver enzyme levels * Participation in other investigational trials without prior approval of the sponsor STUDY SITES Location and Contact Information Please refer to this study by ClinicalTrials.gov identifier NCT00110877 M McShane cmcshane@... Arizona Body Positive, Inc., Phoenix, Arizona, 85006, United States; Not yet recruiting Barbara Casimir, BSN, CCRP Ext. 2225 A. Myers, MD, Principal Investigator Arkansas Health For Life Clinic, Pllc, Little Rock, Arkansas, 72207, United States; Not yet recruiting Montgomery bmontgomery@... Jefferson, MD, Principal Investigator California Goodman Clinic, DBA L.A. Gay and Lesbian Center, Los Angeles, California, 90028, United States; Not yet recruiting Bolan, MD, Principal Investigator East Bay AIDS Center, Berkeley, California, 94705, United States; Not yet recruiting Mandelke mandelh@... Borkert, MD, Principal Investigator AIDS Research Alliance, West Hollywood, California, 90069, United States; Not yet recruiting Grace Gacherja mvertucci@... Brown, MD, Principal Investigator AIDS Healthcare Foundation Research Center, Los Angeles, California, 90015, United States; Not yet recruiting Farthing, MD, Principal Investigator Kaiser Permanente Medical Center, San Francisco, California, 94115, United States; Not yet recruiting W. Fessel, MD, Principal Investigator Cedars-Sinai Medical Center, Los Angeles, California, 90048, United States; Not yet recruiting Gregg Sannes Hardy, PhD, Principal Investigator Kaiser Permanente, Los Angeles, California, 90027, United States; Not yet recruiting Guinto, MPH Marc LaRiviere, MD, Principal Investigator Tony Mills/ Ruane, MD, Los Angeles, California, 90069, United States; Not yet recruiting Alas Ext. 15 Ruane, MD, Principal Investigator Living Hope Clinical Foundation, Long Beach, California, 90813, United States; Not yet recruiting o Yolo ryolo@... Stefan Schneider, MD, Principal Investigator San Francisco VA Medical Center, San Francisco, California, 94121, United States; Not yet recruiting Harry Lampiris, MD, Principal Investigator Colorado University of Colorado, Denver, Colorado, 80262, United States; Not yet recruiting Suzanne Fiorillo suzanne.fiorillo@... B. , MD, Principal Investigator District of Columbia Capital Medical Associates, Washington, District of Columbia, 20036, United States; Not yet recruiting Seymour alex@... Bruce S. Rashbaum, MD, Principal Investigator Washington Univ. Medical Center, Washington, District of Columbia, 20037, United States; Not yet recruiting Bisby nbisby@... Afsoon , MD, Principal Investigator Whitman- Clinic, Washington, District of Columbia, 20009, United States; Not yet recruiting Christiane Geisler Kunthavi Sathasivam, MD, Principal Investigator Florida IDC Research Initiative, Altamonte Springs, Florida, 32701, United States; Not yet recruiting Charmaine Stiles Ext. 3102 cstiles@... Edwin DeJesus, MD, Principal Investigator University of Miami School of Medicine, Miami, Florida, 33136, United States; Not yet recruiting Kaszubski, RN ckaszubs@... Dushyantha T. Jayaweera, MD, Principal Investigator Clin. Res. Ctr. at Tampa General Hospital, Tampa, Florida, 33606, United States; Not yet recruiting Mable Chow Ext. 6460 mable_chow@... P. Nadler, MD, Principal Investigator St. ph's Comprehensive Research Iniitiative, Tampa, Florida, 33611, United States; Not yet recruiting Ext. 228 jennifer.bailey@... Dorece G. Norris, MD, Principal Investigator Treasure Coast Infectious Disease Consultants, Vero Beach, Florida, 32960, United States; Not yet recruiting Jeff Mieras Gerald Pierone, MD, Principal Investigator Richmond, MD, Fort Lauderdale, Florida, 33316, United States; Not yet recruiting Richmond, MD, Principal Investigator Health Positive, Safety Harbor, Florida, 34695, United States; Not yet recruiting Ross Barry M. Rodwick, MD, Principal Investigator HIV Clinical Research, Fort Lauderdale, Florida, 33311, United States; Not yet recruiting Yontif Ext. 224 hyontif@... G. Sension, MD, Principal Investigator Steinhart Medical Associates, Miami, Florida, 33133, United States; Not yet recruiting Amy Sue Liebmann Ext. 232 aliebmann@... Corklin R. Steinhart, MD, Principal Investigator Infectious Disease Research Institute, Inc., Tampa, Florida, 33614, United States; Not yet recruiting Kalliope Halkias kdhalkias@... Bienvenido G. Yangco, MD, Principal Investigator Georgia Atlanta Infectious Disease Group, PC, Atlanta, Georgia, 30309, United States; Not yet recruiting Stadtlander Philip S. Brachman, MD, Principal Investigator Infectious Disease Specialists of Atlanta, Decatur, Georgia, 30033, United States; Not yet recruiting Maclure Robin Dretler, MD, Principal Investigator Mercer University School of Medicine, Macon, Georgia, 31201, United States; Not yet recruiting Harold Katner, MD, Principal Investigator Atlanta Specialty Research, Atlanta, Georgia, 30342, United States; Not yet recruiting L. Usherwood, MMSc, PA-C jusherwood@... I. Marlowe, MD, Principal Investigator AIDS Research Consortium of Atlanta, Inc, Atlanta, Georgia, 20208, United States; Not yet recruiting To Be Determined A. , MD, Principal Investigator Illinois Northstar Medical Center, Chicago, Illinois, 60657, United States; Recruiting Elonia Berger, MD, Principal Investigator Northwestern University Feinberg School of Medicine, Chicago, Illinois, 60611, United States; Not yet recruiting Baiba Berzins Palella, MD, Principal Investigator Kentucky University of Kentucky School of Medicine, Lexington, Kentucky, 40536, United States; Not yet recruiting Plummer slplum2@... N. Greenberg, MD, Principal Investigator Massachusetts Community Research Initiative of New England, Boston, Massachusetts, 02215, United States; Not yet recruiting Anne Habel Ext. 225 ahabel@... Amy Colson, MD, Principal Investigator Community Research Initiative of New England, Springfield, Massachusetts, 01107, United States; Not yet recruiting Margarita Canuel, RN mcanuel@... Anne B. , MD, Principal Investigator Michigan Benson, DO, Berkley, Michigan, 48072, United States; Not yet recruiting Dorothy Dempster dorothydempster@... Benson, DO, Principal Investigator Minnesota Clinic 42, Minneapolis, Minnesota, 55404, United States; Not yet recruiting Vern Appleby vfappleby@... S. Rhame, MD, Principal Investigator New Jersey University Hospital, Camden, New Jersey, 08103, United States; Not yet recruiting Deborah Goraj Ext. 3518 Baxter, MD, Principal Investigator VA NJ Healthcare System, East Orange, New Jersey, 07018, United States; Not yet recruiting Latorre, RN Ext. 2146 Eng, MD, Principal Investigator Saint 's Medical Center, Newark, New Jersey, 07102, United States; Not yet recruiting Fallon jimf@... M. , MD, Principal Investigator New York NBHN, Bronx, New York, 10461, United States; Not yet recruiting Agelo Sedg, RN Leider, MD, Principal Investigator North Carolina Duke University Medical Center, Durham, North Carolina, 27710, United States; Not yet recruiting ta Giner giner001@... B. Hicks, MD, Principal Investigator Jemsek Clinic, Huntersville, North Carolina, 28078, United States; Not yet recruiting Harper eharper@... ph G. Jemsek, MD, Principal Investigator Wake Forest University Health Sciences, Winston Salem, North Carolina, 27157, United States; Not yet recruiting Hauser smhauser@... Aimee Wilkin, MD, Principal Investigator Ohio University of Cincinnati, Cincinnati, Ohio, 45267, United States; Not yet recruiting Tamar Canaan Judith Feinberg, MD, Principal Investigator Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States; Not yet recruiting Colleen Workman Alan Taege, MD, Principal Investigator Oregon The Research & Education Group, Portland, Oregon, 97209, United States; Not yet recruiting Norma ez Sampson, MD, Principal Investigator Pennsylvania Philadelphia FIGHT, Philadelphia, Pennsylvania, 19107, United States; Not yet recruiting Barbara A. Gallagher, RN Karam Mounzer, MD, Principal Investigator The Drexel University College of Medicine, Philadelphia, Pennsylvania, 19102, United States; Not yet recruiting Regina , RN, MSN regina.anthony@... R. Short, MD, Principal Investigator South Carolina The Burnside Clinic, Columbia, South Carolina, 29206, United States; Not yet recruiting Felder, III rick@... Alfred F. Burnside, Jr., MD, Principal Investigator Tennessee Vanderbilt Aids Clinical Trial Center, Nashville, Tennessee, 37203, United States; Not yet recruiting Janet Nicotera Haas, MD, Principal Investigator Texas University of Texas Houston Medical School, Houston, Texas, 77030, United States; Not yet recruiting Berta Ben J. Barnett, MD, Principal Investigator Professional Quality Research, Inc., Austin, Texas, 78756, United States; Not yet recruiting Mol tracy@... Jack Bissett, MD, Principal Investigator North Texas Center for Aids and Clinical Research, Dallas, Texas, 75208, United States; Not yet recruiting Brand, MD, Principal Investigator Central Texas Clinical Research, Austin, Texas, 78705, United States; Not yet recruiting Tom Brinson tbrinson@... Brinson, MD, Principal Investigator University of Texas Medical Branch, Galveston, Texas, 77555, United States; Not yet recruiting Cheryl Mogridge clmogrid@... A. O'Brien, MD, Principal Investigator Special Health Resources for Texas Incorporated, Longview, Texas, 75601, United States; Not yet recruiting Lawrence Anita Scribner, MD, Principal Investigator Montrose Clinic, Houston, Texas, 77098, United States; Not yet recruiting Mark Mall mmall@... R Schrader, MD, Principal Investigator Virginia Hampton Roads Medical Specialists, Hampton, Virginia, 23666, United States; Not yet recruiting Katy Schwarzenberg Ext. 15 hrms21@... Green, MD, Principal Investigator Washington Swedish Medical Center, Seattle, Washington, 98122, United States; Not yet recruiting Algren Shalit, MD, Principal Investigator Wisconsin Froedtert & Medical College Froedtert East Clinic Bldg., Milwaukee, Wisconsin, 53226, United States; Not yet recruiting Mandy Kastner , MD, Principal Investigator Puerto Rico Clinical Research Puerto Rico, Inc., San , 00909-1711, Puerto Rico; Not yet recruiting Ana L. Campos, RN, MBA/HCM Morales , MD, Principal Investigator Quote Link to comment Share on other sites More sharing options...
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