| Enrollment
Is Open to Early Access Program for Experimental HIV Protease Inhibitor TMC114
with Ritonavir in HIV Patients with Limited Treatment Options
This
study is currently recruiting patients.
Verified by Tibotec Pharmaceuticals Limited, Ireland January 2006
Sponsored by: | Tibotec
Pharmaceuticals Limited, Ireland | Information provided by: | Tibotec
Pharmaceuticals Limited, Ireland | ClinicalTrials.gov Identifier: | NCT00245739 |
Purpose
The
purpose of this study is to provide early access to TMC114
(an experimental HIV protease inhibitor) for HIV-1 infected patients
with limited or no treatment options, who have failed multiple antiretroviral
(ARV) regimens, and to evaluate the longer-term safety and tolerability of TMC114/ritonavir in combination
with other antiretrovirals
|
Condition
|
Intervention |
Phase |
|
HIV
Infection |
Drug: TMC114 |
Phase III |
Study Type: Interventional
Study
Design: Treatment, Non-Randomized, Open Label, Active Control,
Single Group Assignment, Safety Study Official Title: Early Access of TMC114 in Combination with Low-Dose
Ritonavir (TMC/r)) and Other Antiretrovirals (ARVs) in Highly
Treatment Experienced HIV-1 Infected Patients with Limited to No Treatment Options.
Further
study details as provided by Tibotec Pharmaceuticals
Limited, Ireland: Primary
Outcomes: Evaluation of safety and tolerability of TMC114/ritonavir with
other antiretrovirals
Expected Total Enrollment: 5,000
Study start date: October 2005 This
is a program to provide early access to TMC114 (a protease inhibitor) for HIV-1
infected patients, who have failed multiple antiretroviral (ARV) regimens and
who are ineligible for participation in any other Tibotec-sponsored
HIV trial.
Patients need to be at least 3-class experienced (PIs,
NRTIs, NtRTIs, NNRTIs or FI), to have previously received 2 different protease
inhibitor-based regimens and to not be virologically suppressed on their current
regimen. Patients
eligible for any other Tibotec sponsored HIV trial but located more than 100 kilometers
away from a study site, will be considered eligible for this early access program.
T This program
will be conducted as an open-label, non-randomized treatment study. Once treatment
with TMC114/r in combination with other antiretrovirals (ARVs) has been initiated
(baseline visit), patients will follow the recommended visit schedule based on
routine clinical care. No
other protease inhibitor combinations other than TMC114/r are to be used in this
study, except atazanavir (ATV) and indinavir (IDV) may be allowed. Trial medication
will be dispensed every 8 weeks. Treatment
with TMC114/r will be continued until treatment-limiting toxicity, loss to follow-up,
patient's withdrawal, pregnancy, discontinuation of TMC114 development or when
TMC114 has become commercially available. Selected
safety and tolerability data, including adverse events will be collected throughout
the study. A urine pregnancy test will be repeated at baseline for female patients
if more than 4 weeks have passed since the test at screening, and urine pregnancy
tests will be performed at all other visits. In
addition, data on CD4 count and viral load will be collected over the treatment
period according to local standard of care practice, in order to ensure that patients
continue to benefit from treatment with TMC114/r. A
final/withdrawal visit as well as a post-trial treatment follow-up contact (4
weeks after the final/withdrawal visit) will be performed. Patients
will take oral doses of 600 mg of TMC114 twice daily in combination with 100 mg
of ritonavir twice daily, in combination with other antiretrovirals.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Inclusion Criteria: ·
Documented
HIV-1 infection ·
Limited
or no treatment options due to virological failure or
intolerance to multiple antiretroviral regimens ·
At least
3 class experienced and has previously received 2 different protease inhibitor-based
regimens ·
CD4 cell
count <= 200 cells/mm3 ·
Not experiencing
adequate virologic
suppression on his/her current regimen and is at risk of
clinical or immunologic progression. Exclusion
Criteria: ·
Primary
HIV-1 infection (unless documented resistance to all currently approved protease
inhibitors participated or is currently participating in a trial with TMC114 ·
Patient
used investigational medication within the last 30 days (except for abacavir/lamivudine and tenofovir/emtricitabine (Truvada) fixed-dose
combinations, and tipranavir (Aptivus) ·
Patient
suffers from any active clinically significant disease (e.g., cardiac dysfunction,
pancreatitis,
acute viral infection) or has evidence of active liver disease, liver impairment/dysfunction
or cirrhosis irrespective
of liver enzyme levels,
or has grade 3 or 4 laboratory abnormalities as defined by National Institute
of Allergy and Infectious Diseases Division of AIDS (DAIDS) grading scheme ·
Female patients that are pregnant or breast-feeding, or of childbearing potential
without using effective non-hormonal birth control methods or not willing to continue
practicing these birth control methods from screening until the last trial related
activity Location
and Contact Information Please
refer to this study by ClinicalTrials.gov identifier NCT00245739
For
more information please see the link below or email info@veritasmedicine.com
Alabama
Health Services
Center, Hobson City,
Alabama, 36201,
United States; Recruiting
BARBARA
HANNA, Principal Investigator
Arizona
Spectrum Medical
Group, Phoenix, Arizona, 85012,
United States; Recruiting
Thanes
Vanig, Principal Investigator
Phoenix Body Positive, Phoenix, Arizona, 85006, United
States; Recruiting ROBERT
MYERS, Principal Investigator
California
Research Unit, San Francisco, California,
94117, United States; Recruiting
Marcus
Conant, Principal Investigator
Douglas C. Cable, Md, Facp, Newport
Beach, California,
92663, United States; Recruiting
Douglas
Cable, Principal Investigator
Center for Special Immunology, Fountain Valley,
California, 92708, United
States; Recruiting
Paul
Cimoch, Principal Investigator
Digestive Disease and Nutrition Associates, San
Francisco, California, 94114, United
States; Recruiting
Richard
Cazen, Principal Investigator
West Hollywood,
California, 90069,
United States; Not yet recruiting
Santa Clara Kaiser Permanente, Santa Clara,
California, 95051,
United States; Recruiting
ALAN
MAN, Principal Investigator
Center for Hiv Prevention and Care - County of Sonoma, Santa
Rosa, California, 95404, United States; Recruiting
Mark
Netherda, Principal Investigator
Beverly Hills,
California, 90211,
United States; Not yet recruiting
Tower Id Medical Associates, Los Angeles,
California, 90048,
United States; Recruiting
Cyril
Gaultier, Principal Investigator
San Francisco,
California, 94121,
United States; Not yet recruiting
Southern
California Permanente Medical Group, Woodland
Hills, California, 91365, United
States; Recruiting Jose
Dryjanski, Principal Investigator
Kaiser Permanente
Medical Center, Los Angeles, California,
90027, United States; Recruiting
WILLIAM
TOWNER, Principal Investigator
Stanford Univ
Hospital O/p-hiv/aids, Stanford, California, 94305,
United States; Recruiting
Andrew
Zolopa, Principal Investigator
Kaiser Permanente-west La, Los Angeles,
California, 90034,
United States; Recruiting
Mark
Katz, Principal Investigator
Hayward, California, 94545, United
States; Not yet recruiting
Cedars
- Sinai Medical
Center, Los Angeles,
California, 90048,
United States; Not
yet recruiting DAVID
HARDY, Principal Investigator
Long Beach,
California, 90813,
United States; Not yet recruiting
La Jolla,
California, 92037,
United States; Not yet recruiting
Synergy Hematocology and Oncology, Los
Angeles, California, 90036, United
States; Recruiting
Michael
Gottlieb, Principal Investigator
Camino Medical Group, Sunnyvale, California, 92103,
United States; Recruiting
Kristin
Razzeca, Principal Investigator
Berkeley, California, 94704, United
States; Not yet recruiting
San Diego,
California, 92103,
United States; Not yet recruiting
Orange Coast Medical Group, Newport Beach,
California, 92663, United
States; Recruiting
Jorge
Rodriguez, Principal Investigator
Vista Medical Partners, Los Angeles,
California, 90210,
United States; Recruiting
David
McDonough, Principal Investigator
34th STREET COMMUNITY
HEALTH CENTER, Bakersfield, California,
93301, United States; Recruiting
Franco
Felizarta, Principal Investigator
Shared Medical Research Foundation, Tarzana, California, 91356,
United States; Recruiting
Jeffrey
Galpin, Principal Investigator
Los Angeles,
California, 90028,
United States; Not yet recruiting
Tarzana Treatment
Center, HIV Clinic, Tarzana, California, 91356, United
States; Recruiting
Phyllis
Cohen, Principal Investigator
PETER RUANE, Los Angeles, California,
90036, United States; Recruiting
Peter
Ruane, Principal Investigator
San Mateo Medical
Center, San Mateo, California, 94403,
United States; Recruiting
Dennis
Israelski, Principal Investigator
Kaiser Permanente-Southern California, San
Diego, California, 92120, United
States; Recruiting
CHRISTOPHER
OBRIEN, Principal Investigator
Willard L. Maletz, Md Inc., Long
Beach, California,
90807, United States; Recruiting
Willard
Maletz, Principal Investigator
CPMC Davies Campus, San Francisco, California,
94114, United States; Recruiting
Virginia Cafaro, Principal Investigator
Kaiser Permanente, Anaheim, California, 92807,
United States; Recruiting
Arnold Henson, Principal Investigator
Connecticut
Connecticut Children's - Medical
Center, Hartford, Connecticut, 06106, United
States; Recruiting
Juan
Salazar, Principal Investigator
District of Columbia
Capital Medical Associates, PC, Washington, District of Columbia, 20036, United
States; Recruiting
Bruce
Rashbaum, Principal Investigator
CARE-ID, Washington, District
of Columbia, 20037, United States; Recruiting
Richard
Elion, Principal Investigator
Whitman Walker Clinic, Washington, District of Columbia, 20009, United
States; Recruiting
Kunthazi Sathasivam, Principal Investigator
Florida
Health Positive, Safety Harbor, Florida,
34695, United States; Recruiting
Barry
Rodwick, Principal Investigator
Biodoron Medical
Center, Hollywood, Florida,
33021, United States; Recruiting
Robert
Keller, Principal Investigator
North Broward Hospital District, Fort Lauderdale,
Florida, 33311,
United States; Recruiting
Michael
Sension, Principal Investigator
Infectious Disease Associates of the Palm Beaches, North
Palm Beach, Florida, 33408, United
States; Recruiting
Leslie
Diaz, Principal Investigator
Wohlfeiler, Piperato & Associates LLC, N. Miami Beach, Florida,
33169, United States; Recruiting
Michael
Wohlfeiler, Principal Investigator
Infectious Disease of Central Florida, Orlando, Florida, 32806, United
States; Recruiting
Ian
Boyd 407-214-1946
William Robbins,
Principal Investigator
Orlando Immunology
Center, Orlando, Florida, 32803,
United States; Recruiting
Edwin
De Jesus, Principal Investigator
Steinhart Medical Associates, Miami, Florida, 33133,
United States; Recruiting
Isabela Sierra, M.D., CRC 305-856-2171
Ext. 262
Corklin Steinhart, M.D., PhD,
Principal Investigator
Morris, Sklaver, Mestre and Denney, Md, Pa, Plantation, Florida, 33317,
United States; Recruiting
Alberto
Mestre, Principal Investigator
Associates In Infectious Diseases, Port St. Lucie, Florida, 34952, United
States; Recruiting
Moti Ramgopal,
Principal Investigator
Infectious Disease Associates of Greater Orlando, Winter
Park, Florida,
32792, United States; Recruiting
JAMES
MCCLELLAN, Principal Investigator
Lifeway Inc., Fort
Lauderdale, Florida, 33334, United
States; Recruiting
Marah Lee, Principal Investigator
Georgia
Infectious Disease Specialist of Atlanta, Decatur, Georgia,
30033, United
States; Recruiting
Robin
Dretler, Principal Investigator
Mercer University
School of Medicine, Macon,
Georgia, 31201,
United States; Recruiting
Harold
Katner, Principal Investigator
Decatur, Georgia,
30033, United
States; Not yet recruiting
Family Healthcare of Atlanta, P.C., Atlanta,
Georgia, 30318, United States; Recruiting
Mark
Tanner, Principal Investigator
Wayne Wellness, Jessup,
Georgia, 31545, United States; Recruiting
Claire
Hicks, Principal Investigator
Atlanta, Georgia,
30308, United
States; Not yet recruiting
Infectious Disease Solutions, Atlanta, Georgia, 30309, United States; Recruiting
Steven
Schmitt 404-351-8873
Christine Zurawski,
Principal Investigator
Idaho
Ryan White Clinic - Family Practice
Medical Center, Boise, Idaho,
83704, United States; Recruiting
Skye
Blue, Principal Investigator
Illinois
Northwestern Memorial Physicians Group, Chicago, Illinois, 60657, United
States; Recruiting
Anthony
Vaccaro, Principal Investigator
Klein and Slotten Medical Associates, Chicago, Illinois, 60610, United
States; Recruiting
Jon
Brockelman 312-280-0996
Ross Slotten, Principal Investigator
Maine
Maine Medical
Center, Portland, Maine, 04102,
United States; Recruiting
ROBERT
SMITH, Principal Investigator
Maryland
Chase Brexton
Health Services, Inc., Baltimore, Maryland, 21229, United
States; Recruiting
Peter
Kadlecik, Principal Investigator
Drs. Albert, Trinh & Posorke, Silver
Spring, Maryland,
20910, United States; Recruiting
Mary
Ellen O'Meara 301-588-3322
LYNETTE H.
POSORKE, Principal Investigator
Massachusetts
Boston, Massachusetts, 02115, United
States; Not yet recruiting
Cambridge, Massachusetts, 02139, United
States; Not yet recruiting
Brigham & Women's Hospital, Boston, Massachusetts, 02115,
United States; Recruiting
Paul
Sax, Principal Investigator
Community Research Initiative, Boston, Massachusetts, 02215,
United States; Recruiting
Amy
COLSON, Principal Investigator
Michigan
Paul Benson, Berkley, Michigan,
48072, United States; Recruiting
Paul
Benson, Principal Investigator
Minnesota
Minneapolis, Minnesota, 55415, United
States; Not yet recruiting
Missouri
Saint Louis,
Missouri, 63110,
United States; Not yet recruiting
Washington University, Saint Louis, Missouri,
63110, United States; Recruiting
TURNER
OVERTON, Principal Investigator
Southampton Healthcare, Inc., St. Louis, Missouri, 63139,
United States; Recruiting
David
Prelutsky, Principal Investigator
Nevada
Las Vegas,
Nevada, 89102,
United States; Recruiting
New Jersey
Garden State Infectious Diseases, Voorhees, New Jersey, 08043,
United States; Recruiting
David
Condoluci, Principal Investigator
Hackensack, New Jersey, 07601, United
States; Not yet recruiting
Newark, New Jersey, 07103, United
States; Not yet recruiting
South Jersey Infectious Disease, Somers Point,
New Jersey, 08244,
United States; Recruiting
Christopher
Lucasti, Principal Investigator
New York
Mt. Vernon,
New York, 10550,
United States; Not yet recruiting
Gervais Frechette, Md, Pc, New York, New York, 10014,
United States; Recruiting
Gervais Frechette, Principal Investigator
New York,
New York, 10016,
United States; Not yet recruiting
Manhasset, New York, 11030, United
States; Not yet recruiting
Aids Community Research Initiative of America, New York, New
York, 10018,
United States; Recruiting
Jerome
Ernst, Principal Investigator
Bronx, New York, 10468, United
States; Not yet recruiting
Catskills Regional
Medical Center, Harris, New
York, 12742,
United States; Recruiting
Gary
Good, Principal Investigator
St. Vincent's Hospital, New York, New York, 10003,
United States; Recruiting
Ricky
Hsu, Principal Investigator
New York,
New York, 10029,
United States; Not yet recruiting
New York,
New York, 10003,
United States; Not yet recruiting
Albany Medical
College, Albany, New York, 12203,
United States; Recruiting
David
Lawrence Herman, Principal Investigator
Community Health Network, Inc., Rochester, New York, 14604,
United States; Recruiting
Steven
Fine, Principal Investigator
North Carolina
Jemsek Clinic, Huntersville, North Carolina, 28078, United
States; Recruiting
Joseph
Jemsek, Principal Investigator
Ohio
Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United
States; Recruiting
Alan
Taege, Principal Investigator
Summa Care
Center, Akron, Ohio, 44304,
United States; Recruiting
TOM
FILE, Principal Investigator
Oregon
Fanno Creek Clinic, Portland, Oregon, 97219, United
States; Recruiting
Gregg
Coodley, Principal Investigator
Research & Education Group, Portland, Oregon, 97209,
United States; Recruiting
James
Sampson, Principal Investigator
Portland, Oregon, 97227, United
States; Not yet recruiting
Pennsylvania
Stephen P. Hauptman, Do, Philadelphia,
Pennsylvania, 19107,
United States; Recruiting
Stephen
Hauptman, Principal Investigator
Faulk Medical
Building, Pittsburgh, Pennsylvania, 15213,
United States; Recruiting
Deborah
McMahon, Principal Investigator
Philadelphia, Pennsylvania, 19124, United
States; Not yet recruiting
Allentown, Pennsylvania, 18102, United
States; Not yet recruiting
Presbyterian Medical
Center, Philadelphia,
Pennsylvania, 19104,
United States; Recruiting
Michael
Silverman 215-662-8356
MICHAEL SILVERMAN,
Principal Investigator
Philadelphia, Pennsylvania, 19106, United
States; Not yet recruiting
Philadelphia Fight, Philadelphia, Pennsylvania, 19107, United
States; Recruiting
Karam Mounzer,
Principal Investigator
Rhode Island
Roger Williams
Medical Center, Providence, Rhode
Island, 02908,
United States; Recruiting
Gail
Skowron, Principal Investigator
South Carolina
Columbia, South Carolina, 29206, United
States; Not yet recruiting
Texas
the Schrader Clinic, Houston, Texas,
77098, United States; Recruiting
Mall
Mark 713-830-3018
Shannon Schrader,
Principal Investigator
Gordon Crofoot, MD, Houston, Texas, 77098, United
States; Recruiting
Gordon
Crofoot, Principal Investigator
Nurture Health Clinic, Huston, Texas, 77098,
United States; Recruiting
Patrick
McNamara, Principal Investigator
Diversified Medical Practices, Houston, Texas, 77027,
United States; Recruiting
Patricia
Salvato, Principal Investigator
Dcol Center
for Clinical Research, Longview, Texas, 75605, United
States; Recruiting
Coppinger Sharon 903-238-8854
Anita Scribner, Principal Investigator
David Powell
Public Health
Center, Austin, Texas, 78751,
United States; Recruiting
Rhonda
Ray 512-972-4901
Katherine Brown, M.D.,
Principal Investigator
Therapeutic Concepts, Houston, Texas, 77004,
United States; Recruiting
Joseph
Gathe, Principal Investigator
Steven M. Pounders, M.D. Pa, Dallas, Texas, 75205, United
States; Recruiting
D.
Trew Deckard 214-520-8833
STEVEN POUNDER, Principal Investigator
Audie L.
Murphy Veterans
Hospital, San Antonio, Texas,
78229, United States; Recruiting
DIANNA
RYNKIEWICZ, Principal Investigator
Dallas, Texas, 75216, United
States; Not yet recruiting
Virginia
Hampton Roads Med Specialists, Hampton, Virginia, 23666, United
States; Recruiting
Stephen
Green, Principal Investigator
Washington
Group Health
Cooperative, Seattle, Washington, 98112,
United States; Recruiting
Robert
Thompson, Principal Investigator
Wisconsin
Madison, Wisconsin, 53792, United
States; Not yet recruiting
Belgium
Brussels, 1090, Belgium; Not yet recruiting
Liège, 4000, Belgium; Not yet recruiting
Yvoir, 5530, Belgium; Not yet recruiting
Brussels, 1200, Belgium; Not yet recruiting
Brussels, 1070, Belgium; Not yet recruiting
Charleroi, 6000, Belgium; Not yet recruiting
Liège, 4000, Belgium; Not yet recruiting
Antwerpen, 2000, Belgium; Not yet recruiting
Brussels, 1000, Belgium; Not yet recruiting
Leuven, 3000, Belgium; Not yet recruiting
Gent, Belgium; Not
yet recruiting
Denmark
Copenhagen, 2100, Denmark; Not yet recruiting
Aalborg, 9100, Denmark; Not yet recruiting
Hvidovre, 2650, Denmark; Not yet recruiting
Aarhus, 8200, Denmark; Not yet recruiting
Odense, 5000, Denmark; Not yet recruiting
Germany
Aachen, 52062, Germany; Not yet recruiting
Salzgitter, 38226, Germany; Not yet recruiting
Berlin, 10439, Germany; Not yet recruiting
Freiburg, 79106, Germany; Not yet recruiting
Würzburg, 97080, Germany; Not yet recruiting
München, 80336, Germany; Not yet recruiting
Frankfurt, 60596, Germany; Not
yet recruiting
Köln, 50937, Germany; Not
yet recruiting
Dÿsseldorf, 40225, Germany; Not yet recruiting
Berlin, 10961, Germany; Not yet recruiting
Munich, 80335, Germany; Not yet recruiting
Koblenz, 56073, Germany; Not yet recruiting
Dortmund, 44137, Germany; Not yet recruiting
Leipzig, 04229, Germany; Not yet recruiting
Hannover, 30159, Germany; Not yet recruiting
München, 80331, Germany; Not yet recruiting
MÜNSTER, 48143, Germany; Not
yet recruiting
Berlin, 13347, Germany; Not yet recruiting
Giessen, 35392, Germany; Not yet recruiting
Berlin, 12200, Germany; Not yet recruiting
Hamburg, 20146, Germany; Not yet recruiting
Osnabrück, 49049, Germany; Not yet recruiting
Hamburg, 20099, Germany; Not yet recruiting
Mannheim, 68161, Germany; Not yet recruiting
Hamburg, 20354, Germany; Not yet recruiting
Bonn, 53127, Germany; Not yet recruiting
Hamburg, 20246, Germany; Not yet recruiting
Freiburg, 79098, Germany; Not yet recruiting
Bochum, 44791, Germany; Not yet recruiting
Berlin, 10551, Germany; Not yet recruiting
Hamburg, 20099, Germany; Not yet recruiting
Berlin, 12157, Germany; Not yet recruiting
Dresden, 01307, Germany; Not yet recruiting
Berlin, 10627, Germany; Not yet recruiting
Berlin, 14057, Germany; Not yet recruiting
Berlin, 10777, Germany; Not yet recruiting
Regensburg, 92053, Germany; Not yet recruiting
Düsseldorf, 40237, Germany; Not
yet recruiting
Berlin, 13353, Germany; Not yet recruiting
Frankfurt, 60590, Germany; Not
yet recruiting
Stuttgart, 70197, Germany; Not yet recruiting
Erlangen, 91054, Germany; Not yet recruiting
Essen, 45122, Germany; Not yet recruiting
MÜNSTER, 48149, Germany; Not
yet recruiting
Köln, 50735, Germany; Not
yet recruiting
Hannover, 30625, Germany; Not yet recruiting
Greece
Athens, 15127, Greece; Not yet recruiting
Athens, 11526, Greece; Not yet recruiting
Athens, 10676, Greece; Not yet recruiting
Piraeus, 18536, Greece; Not yet recruiting
Athens, 12462, Greece; Not yet recruiting
Athens, 11527, Greece; Not yet recruiting
Athens, 11528, Greece; Not yet recruiting
Athens, 16121, Greece; Not yet recruiting
Thessaloniki, 54636, Greece; Not yet recruiting
Athens, 11527, Greece; Not yet recruiting
Hungary
Budapest, 1097, Hungary; Not yet recruiting
Italy
Milano, 20127, Italy; Not yet recruiting
Roma, 00149, Italy; Not
yet recruiting
Grosseto, 58100, Italy; Not yet recruiting
Roma, 00149, Italy; Not
yet recruiting
Lecco, 23900, Italy; Not yet recruiting
Pavia, 27100, Italy; Not yet recruiting
Roma, 00149, Italy; Not
yet recruiting
Pavia, 27100, Italy; Not yet recruiting
Roma, 00149, Italy; Not
yet recruiting
Roma, 00133, Italy; Not
yet recruiting
Lithuania
Kaunas, 47116, Lithuania; Not yet recruiting
Vilnius, 03209, Lithuania; Not yet recruiting
Luxembourg
Luxembourg, 1210, Luxembourg; Not yet recruiting
Netherlands
Enschede, 7511 JX, Netherlands; Not yet recruiting
Rotterdam, 3015 GD, Netherlands; Not yet recruiting
Arnhem, 6815 AD, Netherlands; Not yet recruiting
Tilburg, 5022 GC, Netherlands; Not yet recruiting
Nijmegen, 6525 GA, Netherlands; Not yet recruiting
Groningen, 9713 GZ, Netherlands; Not yet recruiting
Alkmaar, 1815 JD, Netherlands; Not yet recruiting
Amsterdam, 1066 EC, Netherlands; Not yet recruiting
Amsterdam, 1091 AC, Netherlands; Not yet recruiting
Leiden, 2333 ZA, Netherlands; Not yet recruiting
Den Haag, 2545 CH, Netherlands; Not
yet recruiting
Poland
Chorzow, 41-500, Poland; Not yet recruiting
Warszawa, 01-201, Poland; Not
yet recruiting
Szczecin, 71-455, Poland; Not yet recruiting
Wroclaw, 51-149, Poland; Not yet recruiting
Spain
Valencia, 46009, Spain; Not yet recruiting
Madrid, 28029, Spain; Not yet recruiting
Madrid, 28046, Spain; Not yet recruiting
Barcelona, 08025, Spain; Not yet recruiting
Badalona Barcelona, 08916,
Spain; Not
yet recruiting
Madrid, 28034, Spain; Not yet recruiting
Barcelona, 08036, Spain; Not yet recruiting
Baracaldo, 48903, Spain; Not yet recruiting
Barcelona, 08907, Spain; Not yet recruiting
Madrid, 28041, Spain; Not yet recruiting
Donostia, 20014, Spain; Not yet recruiting
Madrid, 28041, Spain; Not yet recruiting
Switzerland
Lausanne, 1011,
Switzerland; Not
yet recruiting
Study
chairs or principal investigators
Tibotec Pharmaceuticals Limited Clinical Trial, Study Director, Tibotec
Pharmaceuticals Limited, Ireland
More
Information To
learn how to participate in this trial please click here. Study
ID Numbers: CR006304
Last Updated: January 28, 2006
Record
first received: October 27, 2005
ClinicalTrials.gov Identifier:
NCT00245739
Health Authority: Ireland:
Irish Agriculture and Food Development Authority; United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-02-16
02/17/06 Source
www.clinicalTrials.gov
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