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TMC114: two studies for patients with treatment-experience
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In the Fall 2005, an Expanded Access Program is expected, and in early 2006 an application for Accelerated Approval is expected to be filed with the FDA by Tibotec Pharmacuetical based on 24-week phase II study results. So, by mid-2006 the FDA is expected to rule on the application. Unless an expected event occurs approval of TMC114 is expected by mid-2006.
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 (see below for sites & information)
TMC114 with Low Dose Ritonavir (RTV) and Other Antiretrovirals in Experienced HIV-1 Infected Patients with Limited or no Treatment Options with <100 CD4 Count & >10,000 Viral Load
This study is currently recruiting patients.
Sponsored by: Tibotec Pharmaceutical
Information provided by: Tibotec Pharmaceutical
www.clinicaltrials.gov
Purpose
This is an open-label safety study to provide early access to TMC114 for HIV-1 infected patients who have failed and exhausted regimens based on commercially available antiretroviral (ARV) therapy and who are ineligible for participation in any other Tibotec-sponsored trial.
Phase III
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study
Official Title: Open-Label Safety Study of TMC114 in Combination with Low Dose RTV and Other ARVs in Highly Experienced HIV-1 Infected Patients with Limited or no Treatment Options
Further Study Details:
Primary Outcomes: The primary objective is to provide early access to TMC114 for highly ARV-experienced HIV-1 infected patients who have failed and exhausted treatment options based on commercially available ARVs.
Secondary Outcomes: The secondary objective is to gather additional information on the safety and tolerability of TMC114 in combination with low dose RTV and other ARVs.
Expected Total Enrollment: 600
Study start: June 2005
This is an open-label safety study to provide early access to TMC114 for HIV-1 infected patients who have failed and exhausted regimens based on commercially available antiretroviral (ARV) therapy and who are ineligible for participation in any other Tibotec-sponsored trial. The safety and tolerability of TMC114 in combination with low dose ritonavir (RTV) and other ARVs in highly ARV-experienced HIV-1 infected patients with limited or no treatment options will be assessed. Treatment will be continued until treatment-limiting toxicity, lost to follow-up, withdrawal, pregnancy, discontinuation of TMC114 development or when TMC114 is commercially available to the patient.
Eligibility
Ages Eligible for Study: 18 Years and above,
Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
* Patient has voluntarily signed the informed consent before initiation of study procedures.
* Patient with documented HIV-1 infection.
* Male or female patient over 18 years of age.
* Patient has limited or no treatment options because of multiple treatment failures.
* Negative pregnancy test for females of childbearing potential.
* CD4 cell count < 100 cells/mm©¯.
* Viral load > 10,000 copies/mL.
Exclusion Criteria:
* Primary HIV-infection.
* Patient is eligible for other Tibotec-sponsored trials.
* Prior or current participation in a trial with TMC114 (except for Phase I studies conducted in HIV-infected patients).
* Use of disallowed concomitant therapy.
* Use of investigational medication within the last 90 days. The following exceptions apply: abacavir/lamivudine and tenofovir/emtricitabine fixed dose combinations; tipranavir; TMC114 should not be used within 14 days following the use of tipranavir. A minimal 14-day washout period is required in which tipranavir must be either interrupted or substituted for an alternative investigator selected PI regimen until baseline visit (Day 1).
* Pregnant or breast-feeding female.
* Female patient of child bearing potential without the use of effective non-hormonal birth control methods or not willing to continue practicing these birth control methods from screening until the last trial-related activity.
* Previously demonstrated clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication (TMC114) or RTV.
* Patients with the following laboratory abnormalities as defined by a standardized grading scheme based on the Division of AIDS (DAIDS) table (updated version from December 2004):*Any grade 3 or 4 toxicity with the following exceptions: Patients with pre-existing diabetes or asymptomatic glucose elevations of grade 3 or 4. Patients with asymptomatic triglyceride elevations of grade 3 or 4 or cholesterol elevations grade 3. *Patient with clinical or laboratory evidence of active liver disease, liver impairment/dysfunction or cirrhosis irrespective of liver enzyme levels.
Note: Patients co-infected with chronic hepatitis B or C will be allowed to enter the trial if their condition is clinically stable. Patients diagnosed with acute viral hepatitis at screening will not be allowed to enroll.
Location and Contact Information
Barbara Sabatino 609-730-7549 bsabatin@tibus.jnj.com
Gino Van Dooren 32-15-292-484 gvdooren@tibbe.jnj.com
Florida
Steinhart Medical Associates, Miami, Florida, 33133, United States; Recruiting
Amy Liebman 305-856-2171 Ext. 232 aliebmann@aol.com
Isabella Sierra 305-856-2171 Ext. 262 isa_small@yahoo.com
Corklin R. Steinhart, M.D., Ph.D., Principal Investigator
Orlando Immunology Center, Orlando, Florida, 32803-1851, United States; Recruiting
Charmaine Stiles, RN 407-647-3960 Ext. 2132 cstiles@okorlando.com
Edwin Dejesus, M.D., Principal Investigator
North Carolina
Jemsek Clinic, Huntersville, North Carolina, 28078, United States; Recruiting
Paula Hutcherson, RN 704-987-2111 phutcherson@jemsekclinic.com
Joseph Jemsek, M.D., Principal Investigator
Trial of TMC114 Administered with Low Dose Ritonavir (RTV) in HIV-1 Infected Treatment Experienced Patients
This study is currently recruiting patients.
Sponsored by: Tibotec Pharmaceutical
Information provided by: Tibotec Pharmaceutical
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.
Phase III
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
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
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
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
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
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
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
Cedars-Sinai Medical Center, Los Angeles, California, 90048, United States; Not yet recruiting
Gregg Sannes 310-423-3755
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
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
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
San Francisco VA Medical Center, San Francisco, California, 94121, United States; Not yet recruiting
Sandra Charles 415-750-6960
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
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
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
Whitman-Walker Clinic, Washington, District of Columbia, 20009, United States; Not yet recruiting
Christiane Geisler 202-745-6150
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
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
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
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
Treasure Coast Infectious Disease Consultants, Vero Beach, Florida, 32960, United States; Not yet recruiting
Jeff Mieras 772-978-9556
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
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
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
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
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
Infectious Disease Specialists of Atlanta, Decatur, Georgia, 30033, United States; Not yet recruiting
Katherine Maclure 404-297-9755
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
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
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
Illinois
Northstar Medical Center, Chicago, Illinois, 60657, United States; Recruiting
Elonia Martin 773-396-2400
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
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
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
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
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
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
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
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
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
New York
NBHN, Bronx, New York, 10461, United States; Not yet recruiting
Agelo Sedg, RN 718-918-7232
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
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
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
Ohio
University of Cincinnati, Cincinnati, Ohio, 45267, United States; Not yet recruiting
Tamar Canaan 573-584-8373
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
Oregon
The Research & Education Group, Portland, Oregon, 97209, United States; Not yet recruiting
Norma Martinez 503-229-8428
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
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
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
Tennessee
Vanderbilt Aids Clinical Trial Center, Nashville, Tennessee, 37203, United States; Not yet recruiting
Janet Nicotera 615-936-1174
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
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
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
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
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
Special Health Resources for Texas Incorporated, Longview, Texas, 75601, United States; Not yet recruiting
Cindy Lawrence 903-234-8808
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
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
Washington
Swedish Medical Center, Seattle, Washington, 98122, United States; Not yet recruiting
Heather Algren 206-386-2523
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
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
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