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

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

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