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Yersinia pestis Infection |
Yersinia pestis |
Clinical Trial: Trial of TMC114 administered with Low Dose Ritonavir (RTV) in HIV-1 Infected Treatment Experienced Patients
This study is currently recruiting patients.
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Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| HIV Infection | Drug: TMC114 | Phase III |
MedlinePlus related topics: AIDS
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Controlled, Open-label Trial to Compare the Efficacy, Safety and Tolerability of TMC114/RTV versus LPV/RTV in Treatment-experienced HIV-1 Infected Patients
Further Study Details:
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
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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00110877
Christopher M McShane 609.730.7518 cmcshane@tibus.jnj.com
Arizona
Body Positive, Inc., Phoenix, Arizona, 85006, United States; Not yet recruiting
Barbara Casimir, BSN, CCRP 602-307-5330 Ext. 2225
Robert A. Myers, MD, Principal Investigator
Robert A. Myers, MD, Principal Investigator
Arkansas
Health For Life Clinic, Pllc, Little Rock, Arkansas, 72207, United States; Not yet recruiting
Benjamin Montgomery 501-603-0003 bmontgomery@hflclinic.com
Thomas Jefferson, MD, Principal Investigator
Thomas Jefferson, MD, Principal Investigator
California
Jeffrey Goodman Clinic, DBA L.A. Gay and Lesbian Center, Los Angeles, California, 90028, United States; Not yet recruiting
Robert Bolan, MD, Principal Investigator
East Bay AIDS Center, Berkeley, California, 94705, United States; Not yet recruiting
Jamie Mandelke 510-204-1291 mandelh@sutterhealth.org
Claire Borkert, MD, Principal Investigator
Claire Borkert, MD, Principal Investigator
AIDS Research Alliance, West Hollywood, California, 90069, United States; Not yet recruiting
Grace Gacherja 310-358-2429 mvertucci@aidsresearch.org
Stephen Brown, MD, Principal Investigator
Stephen Brown, MD, Principal Investigator
AIDS Healthcare Foundation Research Center, Los Angeles, California, 90015, United States; Not yet recruiting
Charles Farthing, MD, Principal Investigator
Kaiser Permanente Medical Center, San Francisco, California, 94115, United States; Not yet recruiting
Brooke Anderson 415-833-3480
Jeffrey W. Fessel, MD, Principal Investigator
Jeffrey W. Fessel, MD, Principal Investigator
Cedars-Sinai Medical Center, Los Angeles, California, 90048, United States; Not yet recruiting
Gregg Sannes 310-423-3755
David Hardy, PhD, Principal Investigator
David Hardy, PhD, Principal Investigator
Kaiser Permanente, Los Angeles, California, 90027, United States; Not yet recruiting
Jessica Guinto, MPH 323-783-7404
Marc LaRiviere, MD, Principal Investigator
Marc LaRiviere, MD, Principal Investigator
Tony Mills/ Peter Ruane, MD, Los Angeles, California, 90069, United States; Not yet recruiting
Brian Alas 310-550-1010 Ext. 15
Peter Ruane, MD, Principal Investigator
Peter Ruane, MD, Principal Investigator
Living Hope Clinical Foundation, Long Beach, California, 90813, United States; Not yet recruiting
Ronaldo Yolo 562-624-4943 ryolo@chw.edu
Stefan Schneider, MD, Principal Investigator
Stefan Schneider, MD, Principal Investigator
San Francisco VA Medical Center, San Francisco, California, 94121, United States; Not yet recruiting
Sandra Charles 415-750-6960
Harry Lampiris, MD, Principal Investigator
Harry Lampiris, MD, Principal Investigator
Colorado
University of Colorado, Denver, Colorado, 80262, United States; Not yet recruiting
Suzanne Fiorillo 303-315-3203 suzanne.fiorillo@uchsc.edu
Thomas B. Campbell, MD, Principal Investigator
Thomas B. Campbell, MD, Principal Investigator
District of Columbia
Capital Medical Associates, Washington, District of Columbia, 20036, United States; Not yet recruiting
Alex Seymour 202-822-6311 alex@dcdocs.com
Bruce S. Rashbaum, MD, Principal Investigator
Bruce S. Rashbaum, MD, Principal Investigator
George Washington Univ. Medical Center, Washington, District of Columbia, 20037, United States; Not yet recruiting
Nicole Bisby 202-741-2442 nbisby@mfa.gwu.edu
Afsoon Roberts, MD, Principal Investigator
Afsoon Roberts, MD, Principal Investigator
Whitman-Walker Clinic, Washington, District of Columbia, 20009, United States; Not yet recruiting
Christiane Geisler 202-745-6150
Kunthavi Sathasivam, MD, Principal Investigator
Kunthavi Sathasivam, MD, Principal Investigator
Florida
IDC Research Initiative, Altamonte Springs, Florida, 32701, United States; Not yet recruiting
Charmaine Stiles 407-647-3960 Ext. 3102 cstiles@oicorlando.com
Edwin DeJesus, MD, Principal Investigator
Edwin DeJesus, MD, Principal Investigator
University of Miami School of Medicine, Miami, Florida, 33136, United States; Not yet recruiting
Christopher Kaszubski, RN 305-243-5621 ckaszubs@med.miami.edu
Dushyantha T. Jayaweera, MD, Principal Investigator
Dushyantha T. Jayaweera, MD, Principal Investigator
Clin. Res. Ctr. at Tampa General Hospital, Tampa, Florida, 33606, United States; Not yet recruiting
Mable Chow 813-307-8015 Ext. 6460 mable_chow@doh.state.sl.us
Jeffrey P. Nadler, MD, Principal Investigator
Jeffrey P. Nadler, MD, Principal Investigator
St. Joseph's Comprehensive Research Iniitiative, Tampa, Florida, 33611, United States; Not yet recruiting
Jennifer Bailey 813-870-4760 Ext. 228 jennifer.bailey@baycare.org
Dorece G. Norris, MD, Principal Investigator
Dorece G. Norris, MD, Principal Investigator
Treasure Coast Infectious Disease Consultants, Vero Beach, Florida, 32960, United States; Not yet recruiting
Jeff Mieras 772-978-9556
Gerald Pierone, MD, Principal Investigator
Gerald Pierone, MD, Principal Investigator
Gary Richmond, MD, Fort Lauderdale, Florida, 33316, United States; Not yet recruiting
Gary Richmond, MD, Principal Investigator
Health Positive, Safety Harbor, Florida, 34695, United States; Not yet recruiting
Tiffany Ross 727-725-9931
Barry M. Rodwick, MD, Principal Investigator
Barry M. Rodwick, MD, Principal Investigator
HIV Clinical Research, Fort Lauderdale, Florida, 33311, United States; Not yet recruiting
Howard Yontif 954-467-3006 Ext. 224 hyontif@nbhd.org
Michael G. Sension, MD, Principal Investigator
Michael G. Sension, MD, Principal Investigator
Steinhart Medical Associates, Miami, Florida, 33133, United States; Not yet recruiting
Amy Sue Liebmann 305-856-2171 Ext. 232 aliebmann@aol.com
Corklin R. Steinhart, MD, Principal Investigator
Corklin R. Steinhart, MD, Principal Investigator
Infectious Disease Research Institute, Inc., Tampa, Florida, 33614, United States; Not yet recruiting
Kalliope Halkias 813-875-4374 kdhalkias@idrifla.com
Bienvenido G. Yangco, MD, Principal Investigator
Bienvenido G. Yangco, MD, Principal Investigator
Georgia
Atlanta Infectious Disease Group, PC, Atlanta, Georgia, 30309, United States; Not yet recruiting
Scott Stadtlander 404-355-3161
Philip S. Brachman, MD, Principal Investigator
Philip S. Brachman, MD, Principal Investigator
Infectious Disease Specialists of Atlanta, Decatur, Georgia, 30033, United States; Not yet recruiting
Katherine Maclure 404-297-9755
Robin Dretler, MD, Principal Investigator
Robin Dretler, MD, Principal Investigator
Mercer University School of Medicine, Macon, Georgia, 31201, United States; Not yet recruiting
Shawn Jackson 478-301-5837
Harold Katner, MD, Principal Investigator
Harold Katner, MD, Principal Investigator
Atlanta Specialty Research, Atlanta, Georgia, 30342, United States; Not yet recruiting
Jenny L. Usherwood, MMSc, PA-C 404-459-0002 jusherwood@mindspring.com
Steven I. Marlowe, MD, Principal Investigator
Steven I. Marlowe, MD, Principal Investigator
AIDS Research Consortium of Atlanta, Inc, Atlanta, Georgia, 20208, United States; Not yet recruiting
To Be Determined 404-876-2317
Melanie A. Thompson, MD, Principal Investigator
Melanie A. Thompson, MD, Principal Investigator
Illinois
Northstar Medical Center, Chicago, Illinois, 60657, United States; Recruiting
Elonia Martin 773-396-2400
Daniel Berger, MD, Principal Investigator
Daniel Berger, MD, Principal Investigator
Northwestern University Feinberg School of Medicine, Chicago, Illinois, 60611, United States; Not yet recruiting
Baiba Berzins 312-695-5012
Frank Palella, MD, Principal Investigator
Frank Palella, MD, Principal Investigator
Kentucky
University of Kentucky School of Medicine, Lexington, Kentucky, 40536, United States; Not yet recruiting
Stacy Plummer 859-257-5467 slplum2@uky.edu
Richard N. Greenberg, MD, Principal Investigator
Richard N. Greenberg, MD, Principal Investigator
Massachusetts
Community Research Initiative of New England, Boston, Massachusetts, 02215, United States; Not yet recruiting
Anne Habel 617-778-5454 Ext. 225 ahabel@crine.org
Amy Colson, MD, Principal Investigator
Amy Colson, MD, Principal Investigator
Community Research Initiative of New England, Springfield, Massachusetts, 01107, United States; Not yet recruiting
Margarita Canuel, RN 413-734-2264 mcanuel@crine.org
Anne B. Morris, MD, Principal Investigator
Anne B. Morris, MD, Principal Investigator
Michigan
Paul Benson, DO, Berkley, Michigan, 48072, United States; Not yet recruiting
Dorothy Dempster 248-544-9300 dorothydempster@doctorbewell.com
Paul Benson, DO, Principal Investigator
Paul Benson, DO, Principal Investigator
Minnesota
Clinic 42, Minneapolis, Minnesota, 55404, United States; Not yet recruiting
Vern Appleby 954-524-2250 vfappleby@earthlink.net
Frank S. Rhame, MD, Principal Investigator
Frank S. Rhame, MD, Principal Investigator
New Jersey
Cooper University Hospital, Camden, New Jersey, 08103, United States; Not yet recruiting
Deborah Goraj 856-963-6890 Ext. 3518
John Baxter, MD, Principal Investigator
John Baxter, MD, Principal Investigator
VA NJ Healthcare System, East Orange, New Jersey, 07018, United States; Not yet recruiting
Mayra Latorre, RN 973-676-1000 Ext. 2146
Robert Eng, MD, Principal Investigator
Robert Eng, MD, Principal Investigator
Saint Michael's Medical Center, Newark, New Jersey, 07102, United States; Not yet recruiting
James Fallon 973-877-2663 jimf@cathedralhealth.org
Stephen M. Smith, MD, Principal Investigator
Stephen M. Smith, MD, Principal Investigator
New York
NBHN, Bronx, New York, 10461, United States; Not yet recruiting
Agelo Sedg, RN 718-918-7232
Jason Leider, MD, Principal Investigator
Jason Leider, MD, Principal Investigator
North Carolina
Duke University Medical Center, Durham, North Carolina, 27710, United States; Not yet recruiting
Julieta Giner 919-681-4848 giner001@mc.duke.edu
Charles B. Hicks, MD, Principal Investigator
Charles B. Hicks, MD, Principal Investigator
Jemsek Clinic, Huntersville, North Carolina, 28078, United States; Not yet recruiting
Emily Harper 704-987-2111 eharper@jemsekclinic.com
Joseph G. Jemsek, MD, Principal Investigator
Joseph G. Jemsek, MD, Principal Investigator
Wake Forest University Health Sciences, Winston Salem, North Carolina, 27157, United States; Not yet recruiting
Sandra Hauser 336-716-4262 smhauser@wfubmc.edu
Aimee Wilkin, MD, Principal Investigator
Aimee Wilkin, MD, Principal Investigator
Ohio
University of Cincinnati, Cincinnati, Ohio, 45267, United States; Not yet recruiting
Tamar Canaan 573-584-8373
Judith Feinberg, MD, Principal Investigator
Judith Feinberg, MD, Principal Investigator
Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States; Not yet recruiting
Colleen Workman 216-444-5834
Alan Taege, MD, Principal Investigator
Alan Taege, MD, Principal Investigator
Oregon
The Research & Education Group, Portland, Oregon, 97209, United States; Not yet recruiting
Norma Martinez 503-229-8428
James Sampson, MD, Principal Investigator
James Sampson, MD, Principal Investigator
Pennsylvania
Philadelphia FIGHT, Philadelphia, Pennsylvania, 19107, United States; Not yet recruiting
Barbara A. Gallagher, RN 215-790-1788
Karam Mounzer, MD, Principal Investigator
Karam Mounzer, MD, Principal Investigator
The Drexel University College of Medicine, Philadelphia, Pennsylvania, 19102, United States; Not yet recruiting
Regina Anthony, RN, MSN 215-762-3251 regina.anthony@drexelmed.edu
William R. Short, MD, Principal Investigator
William R. Short, MD, Principal Investigator
South Carolina
The Burnside Clinic, Columbia, South Carolina, 29206, United States; Not yet recruiting
Richard Felder, III 803-787-1113 rick@burnsideclinic.com
Alfred F. Burnside, Jr., MD, Principal Investigator
Alfred F. Burnside, Jr., MD, Principal Investigator
Tennessee
Vanderbilt Aids Clinical Trial Center, Nashville, Tennessee, 37203, United States; Not yet recruiting
Janet Nicotera 615-936-1174
David Haas, MD, Principal Investigator
David Haas, MD, Principal Investigator
Texas
University of Texas Houston Medical School, Houston, Texas, 77030, United States; Not yet recruiting
Berta Garcia 713-500-5483
Ben J. Barnett, MD, Principal Investigator
Ben J. Barnett, MD, Principal Investigator
Professional Quality Research, Inc., Austin, Texas, 78756, United States; Not yet recruiting
Tracy Mol 512-374-0677 tracy@pqrinc.com
Jack Bissett, MD, Principal Investigator
Jack Bissett, MD, Principal Investigator
North Texas Center for Aids and Clinical Research, Dallas, Texas, 75208, United States; Not yet recruiting
John Gonzalez 214-941-4000
David Brand, MD, Principal Investigator
David Brand, MD, Principal Investigator
Central Texas Clinical Research, Austin, Texas, 78705, United States; Not yet recruiting
Tom Brinson 512-480-9660 tbrinson@ctcrcorp.com
Cynthia Brinson, MD, Principal Investigator
Cynthia Brinson, MD, Principal Investigator
University of Texas Medical Branch, Galveston, Texas, 77555, United States; Not yet recruiting
Cheryl Mogridge 409-772-3991 clmogrid@utmb.edu
William A. O'Brien, MD, Principal Investigator
William A. O'Brien, MD, Principal Investigator
Special Health Resources for Texas Incorporated, Longview, Texas, 75601, United States; Not yet recruiting
Cindy Lawrence 903-234-8808
Anita Scribner, MD, Principal Investigator
Anita Scribner, MD, Principal Investigator
Montrose Clinic, Houston, Texas, 77098, United States; Not yet recruiting
Mark Mall 713-830-3018 mmall@montroseclinic.org
Shannon R Schrader, MD, Principal Investigator
Shannon R Schrader, MD, Principal Investigator
Virginia
Hampton Roads Medical Specialists, Hampton, Virginia, 23666, United States; Not yet recruiting
Katy Schwarzenberg 757-838-8677 Ext. 15 hrms21@hotmail.com
Stephen Green, MD, Principal Investigator
Stephen Green, MD, Principal Investigator
Washington
Swedish Medical Center, Seattle, Washington, 98122, United States; Not yet recruiting
Heather Algren 206-386-2523
Peter Shalit, MD, Principal Investigator
Peter Shalit, MD, Principal Investigator
Wisconsin
Froedtert & Medical College Froedtert East Clinic Bldg., Milwaukee, Wisconsin, 53226, United States; Not yet recruiting
Mandy Kastner 414-805-6444
Michael Frank, MD, Principal Investigator
Michael Frank, MD, Principal Investigator
Puerto Rico
Clinical Research Puerto Rico, Inc., San Juan, 00909-1711, Puerto Rico; Not yet recruiting
Ana L. Campos, RN, MBA/HCM 787-723-5945
Javier Morales Ramirez, MD, Principal Investigator
Javier Morales Ramirez, MD, Principal Investigator
More Information
Study ID Numbers: TMC114-C214
Record last reviewed: May 2005
Last Updated: May 13, 2005
Record first received: May 13, 2005
ClinicalTrials.gov Identifier: NCT00110877
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-05-17
Record last reviewed: May 2005
Last Updated: May 13, 2005
Record first received: May 13, 2005
ClinicalTrials.gov Identifier: NCT00110877
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-05-17
Source: ClinicalTrials.gov
Cache Date: May 18, 2005
Resources
- Plague (Centers for Disease Control and Prevention)
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