AzTrials
AzTrials

HIV InfectionsNCT00245739

TMC114-C226: An Early Access Program to Evaluate the Long-term Safety and Tolerability of TMC114 Combined With a Low Dose of Ritonavir (TMC114/r) With Other Antiretrovirals, for HIV-1 Infected Patients Who Have Failed Multiple Antiretroviral Regimens.

A study testing TMC-114 in people with HIV Infections, run by Tibotec Pharmaceuticals, Ireland at 394 sites in 22 countries.

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Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to provide early access to TMC114 (a 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/r in combination with other antiretrovirals Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
TMC-114
Type of treatment
Pill or oral medicine
How many people
Not given
Where
394 sitesin 22 countries
Study dates
Start not givento not given
Phase
Expanded access
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient with documented HIV-1 infection
  • has limited or no treatment options due to virological failure or intolerance to multiple antiretroviral regimens
  • is at least 3 class experienced and has previously received 2 different protease inhibitor-based regimens
  • has a CD4 cell count <= 200 cells/mm3
  • is not achieving adequate virologic suppression on his/her current regimen and is at risk of clinical or immunologic progression.

Who cannot join

  • Patient has 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 fixed dose combinations, and tipranavir)
  • 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

Trial locations and contacts

394 sites in 22 countries.

394 sites in 22 countries

United States202 sites

  • Study site

    Akron, Ohio

  • Study site

    Albany, New York

  • Study site

    Albuquerque, New Mexico

  • Study site

    Allentown, Pennsylvania

  • Study site

    Anaheim, California

  • Study site

    Annandale, Virginia

  • Study site

    Anniston, Alabama

  • Study site

    Asheville, North Carolina

  • Study site

    Atlanta, Georgia

  • Study site

    Augusta, Georgia

  • Study site

    Austell, Georgia

  • Study site

    Austin, Texas

  • Study site

    Bakersfield, California

  • Study site

    Baldwin Park, California

  • Study site

    Baltimore, Maryland

  • Study site

    Bangor, Maine

  • Study site

    Berkley, Michigan

  • Study site

    Bethesda, Maryland

  • Study site

    Beverly Hills, California

  • Study site

    Birmingham, Alabama

  • Study site

    Boise, Idaho

  • Study site

    Boston, Massachusetts

  • Study site

    Boynton Beach, Florida

  • Study site

    Brandon, Florida

  • Study site

    Briarcliff, New York

  • Study site

    Bronxville, New York

  • Study site

    Brooklyn, New York

  • Study site

    Bryan, Texas

  • Study site

    Cambridge, Massachusetts

  • Study site

    Carmichael, California

  • Study site

    Chapel Hill, North Carolina

  • Study site

    Charleston, South Carolina

  • Study site

    Charlottesville, Virginia

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    Cleveland, Ohio

  • Study site

    Columbia, Missouri

  • Study site

    Columbia, South Carolina

  • Study site

    Columbus, Ohio

  • Study site

    Dallas, Texas

  • Study site

    Dayton, Ohio

  • Study site

    Decatur, Georgia

  • Study site

    Decatur, Illinois

  • Study site

    Denver, Colorado

  • Study site

    Detroit, Michigan

  • Study site

    East Orange, New Jersey

  • Study site

    Easton, Pennsylvania

  • Study site

    Eau Claire, Wisconsin

  • Study site

    El Paso, Texas

  • Study site

    Elkton, Maryland

  • Study site

    Fairfax, Virginia

  • Study site

    Flushing, New York

  • Study site

    Fontana, California

  • Study site

    Fort Lauderdale, Florida

  • Study site

    Fort Laudersale, Florida

  • Study site

    Fort Myers, Florida

  • Study site

    Fort Worth, Texas

  • Study site

    Fountain Valley, California

  • Study site

    French Camp, California

  • Study site

    Galloway, New Jersey

  • Study site

    Galveston, Texas

  • Study site

    Glastonbury, Connecticut

  • Study site

    Glendale, California

  • Study site

    Granite City, Illinois

  • Study site

    Greensboro, North Carolina

  • Study site

    Greenville, North Carolina

  • Study site

    Greenwood, Mississippi

  • Study site

    Grosse Pointe Woods, Michigan

  • Study site

    Hackensack, New Jersey

  • Study site

    Hamilton, New Jersey

  • Study site

    Hampton, Virginia

  • Study site

    Harbor City, California

  • Study site

    Harlingen, Texas

  • Study site

    Harris, New York

  • Study site

    Hartford, Connecticut

  • Study site

    Hayward, California

  • Study site

    Henderson, Kentucky

  • Study site

    Hermitage, Tennessee

  • Study site

    Hershey, Pennsylvania

  • Study site

    Hoboken, New Jersey

  • Study site

    Hollywood, Florida

  • Study site

    Honolulu, Hawaii

  • Study site

    Houston, Texas

  • Study site

    Huntersville, North Carolina

  • Study site

    Jacksonville, Florida

  • Study site

    Jersey City, New Jersey

  • Study site

    Jesup, Georgia

  • Study site

    Johnson City, Tennessee

  • Study site

    Joliet, Illinois

  • Study site

    Kahului, Hawaii

  • Study site

    Kansas City, Missouri

  • Study site

    Kapaa, Hawaii

  • Study site

    Knoxville, Tennessee

  • Study site

    LaBelle, Florida

  • Study site

    Lackland City, Texas

  • Study site

    Las Vegas, Nevada

  • Study site

    Lebanon, New Hampshire

  • Study site

    Lewiston, Maine

  • Study site

    Loma Linda, California

  • Study site

    Long Beach, California

  • Study site

    Long Branch, New Jersey

  • Study site

    Longview, Texas

  • Study site

    Los Angeles, California

  • Study site

    Los Angles, California

  • Study site

    Macon, Georgia

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    Madison, Wisconsin

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    Manhasset, New York

  • Study site

    Maplewood, New Jersey

  • Study site

    Marietta, Georgia

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    Marquette, Michigan

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    Melbourne, Florida

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    Memphis, Tennessee

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    Mesa, Arizona

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    Miami, Florida

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    Miami Beach, Florida

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    Milwaukee, Wisconsin

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    Minneapolis, Minnesota

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    Monmouth, Maine

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    Mount Vernon, New York

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    Nashville, Tennessee

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    Neptune City, New Jersey

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    New Haven, Connecticut

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    New Orleans, Louisiana

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    New York, New York

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    Newark, New Jersey

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    Newport Beach, California

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    Newport News, Virginia

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    Norfolk, Virginia

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    North Miami Beach, Florida

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    North Palm Beach, Florida

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    Norwalk, Connecticut

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    Norwich, Connecticut

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    Oakland, California

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    Oklahoma City, Oklahoma

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    Orlando, Florida

  • Study site

    Paducah, Kentucky

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    Palm Springs, California

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    Palo Alto, California

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    Panorama City, California

  • Study site

    Paramount, California

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    Perth Amboy, New Jersey

  • Study site

    Philadelphia, Pennsylvania

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    Phoenix, Arizona

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    Pittsburgh, Pennsylvania

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    Plantation, Florida

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    Port Saint Lucie, Florida

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    Portland, Maine

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    Portland, Oregon

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    Portsmouth, Virginia

  • Study site

    Providence, Rhode Island

  • Study site

    Richmond, California

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    Richmond, Virginia

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    Riverdale, Georgia

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    Rochester, New York

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    Rockford, Illinois

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    Round Lake Beach, Illinois

  • Study site

    Safety Harbor, Florida

  • Study site

    Salinas, California

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    San Antonio, Texas

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    San Diego, California

  • Study site

    San Diego, La Jolla, California

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    San Francisco, California

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    San Mateo, California

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    San Rafael, California

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    Santa Ana, California

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    Santa Clara, California

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    Santa Clarita, California

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    Santa Rosa, California

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    Sarasota, Florida

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    Seattle, Washington

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    Silver Spring, Maryland

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    Somers Point, New Jersey

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    Springfield, Illinois

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    Springfield, Massachusetts

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    St Louis, Missouri

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    Stanford, California

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    Stanford, Connecticut

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    Sunnyvale, California

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    Syracuse, New York

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    Tampa, Florida

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    Tarzana, California

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    The Bronx, New York

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    Topeka, Kansas

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    Tucker, Georgia

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    Tucson, Arizona

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    Ukiah, California

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    Valhalla, New York

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    Vernon Rockville, Connecticut

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    Vero Beach, Florida

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    Voorhees Township, New Jersey

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    Washington D.C., District of Columbia

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    West Columbia, South Carolina

  • Study site

    West Hollywood, California

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    West Orange, New Jersey

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    West Palm Beach, Florida

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    West Reading, Pennsylvania

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    Westfield, New Jersey

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    Wilmington, North Carolina

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    Winston-Salem, North Carolina

  • Study site

    Winter Park, Florida

  • Study site

    Woodland Hills, California

  • Study site

    Yonkers, New York

Other trials in United States

Spain56 sites

  • Study site

    A Coruña

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    Alicante

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    Badajoz

  • Study site

    Barakaldo Vizcaya S/N

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    Barcelona

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    Bilbao

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    Cáceres

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    Calella (Barcelona)

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    Castellon

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    Córdoba

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    Cuenca

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    Donostia Guipuzcoa

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    El Palmar Murcia N/A

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    Elche

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    Figueres

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    Fuenlabrada

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    Gijon Asturias

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    Girona

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    Granada

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    Guadalajara

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    Huesca

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    Ibiza Town

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    Jérez

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    Lleida

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    Logroño

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    Madrid

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    Málaga

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    Manresa

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    Maó

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    Murcia

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    Oviedo

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    Palma de Mallorca

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    Palma de Mallorca Illes Balear

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    Pamplona

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    Puerto Real

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    Sabadell

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    San Cristóbal de La Laguna

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    Santa Cruz de Tenerife

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    Santander

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    Santiago de Compostela

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    Vic

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    Vigo

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    Villafranca Del Penedes

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    Vizcaya N/A

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    Zaragoza

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Germany35 sites

  • Study site

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    Chemnitz

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    Cologne

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    Dortmund

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    Dresden

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    Erlangen

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    Essen

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    Frankfurt

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    Freiburg im Breisgau

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    Giessen

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    Hamburg

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    Hanover

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    Kiel

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    Leipzig

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    Mainz

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    Münster

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    Nuremberg

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    Regensburg

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    Würzburg

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Canada18 sites

  • Study site

    Calgary, Alberta

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    Edmonton, Alberta

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    Halifax, Nova Scotia

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    Hamilton, Ontario

  • Study site

    Kingston, Ontario

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    London, Ontario

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    Moncton, New Brunswick

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    Montreal, Quebec

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    Ottawa, Ontario

  • Study site

    Rouyn-Noranda, Quebec

  • Study site

    Ste-Foy, Quebec

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Columbia

  • Study site

    Vancouver

  • Study site

    Vancouver British

  • Study site

    Whitby, Ontario

  • Study site

    Windsor, Ontario

  • Study site

    Winnipeg, Manitoba

Other trials in Canada

Netherlands12 sites

  • Study site

    Alkmaar

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    Amsterdam

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    Arnhem

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    Eindhoven

  • Study site

    Enschede

  • Study site

    Groningen

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    Leiden

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    Maastricht

  • Study site

    Nijmegen

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    Rotterdam

  • Study site

    The Hague

  • Study site

    Tilburg

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Russia12 sites

  • Study site

    Kazan'

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    Krasnodar

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    Moscow

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    Nizhny Novgorod

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    Novosibirsk Region

  • Study site

    Rostov-on-Don

  • Study site

    Saint Petersburg

  • Study site

    Smolensk

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    Tver'

  • Study site

    Volgograd

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    Voronezh

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    Yekaterinburg

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Switzerland11 sites

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    Aarau

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    Basel

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    Chur

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    Geneva

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    Lausanne

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    Lugano

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    Sankt Gallen

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    Zurich Zh

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Belgium8 sites

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Denmark5 sites

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Sweden5 sites

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Taiwan4 sites

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Greece3 sites

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Malaysia3 sites

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Puerto Rico3 sites

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    Ponce Pr

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    San Juan

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Turkey (Türkiye)2 sites

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Czechia1 site

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    Prague

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Hungary1 site

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    Budapest

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Luxembourg1 site

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    Luxembourg

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Slovenia1 site

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    Ljubljana

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Thailand1 site

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    Bangkok

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Venezuela1 site

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    Caracas

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About this 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.

The purpose of this study is to provide early access to TMC114 (a 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/r in combination with other antiretrovirals

Read the detailed description

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.

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.

Conditions
HIV Infections
Being tested
TMC-114
Keywords
HIV infections, HIV-1, TMC114, Early access, Highly antiretroviral treatment experienced patients, Anti-retroviral agents
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TMC-114Drug

    600/100 mg tablets of TMC114/rtv BID until commercial available to the subject

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2005 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Expanded access
IDs, dates and publications
ClinicalTrials.gov ID
NCT00245739
Sponsor's protocol ID
CR006304
Other IDs
TMC114-C226
Status last verified
Apr 2014
First submitted
27 Oct 2005
Last updated
11 Apr 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing TMC-114 in people with HIV Infections, run by Tibotec Pharmaceuticals, Ireland at 394 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 394 sites in United States, Spain, Germany, Canada, Netherlands and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00245739.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2014.

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