TMC114-C214: Trial of TMC114 Administered With Low Dose Ritonavir (RTV) in HIV-1 Infected Treatment Experienced Patients
NCT ID: NCT00110877
Last Updated: 2015-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
604 participants
INTERVENTIONAL
2005-04-30
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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002
LPV/rtv One 400mg LPV tablet twice daily with 100mg RTV
LPV/rtv
One 400mg LPV tablet twice daily with 100mg RTV
001
TMC114/rtv Two 300mg TMC114 tablets twice daily with 100mg RTV
TMC114/rtv
Two 300mg TMC114 tablets twice daily with 100mg RTV
Interventions
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LPV/rtv
One 400mg LPV tablet twice daily with 100mg RTV
TMC114/rtv
Two 300mg TMC114 tablets twice daily with 100mg RTV
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Tibotec Pharmaceuticals, Ireland
INDUSTRY
Responsible Party
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Principal Investigators
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Tibotec Pharmaceuticals Clinical Trial
Role: STUDY_DIRECTOR
Tibotec Pharmaceutical Limited
Locations
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Phoenix, Arizona, United States
Little Rock, Arkansas, United States
Beverly Hills, California, United States
Long Beach, California, United States
Los Angeles, California, United States
San Francisco, California, United States
West Hollywood, California, United States
Denver, Colorado, United States
Washington D.C., District of Columbia, United States
Fort Lauderdale, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Safety Harbor, Florida, United States
Tampa, Florida, United States
Vero Beach, Florida, United States
Atlanta, Georgia, United States
Macon, Georgia, United States
Chicago, Illinois, United States
Boston, Massachusetts, United States
Berkley, Michigan, United States
Camden, New Jersey, United States
East Orange, New Jersey, United States
Newark, New Jersey, United States
The Bronx, New York, United States
Durham, North Carolina, United States
Huntersville, North Carolina, United States
Winston-Salem, North Carolina, United States
Cleveland, Ohio, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Columbia, South Carolina, United States
Austin, Texas, United States
Dallas, Texas, United States
Galveston, Texas, United States
Houston, Texas, United States
Longview, Texas, United States
Hampton, Virginia, United States
Seattle, Washington, United States
Milwaukee, Wisconsin, United States
Buenos Aires, , Argentina
Córdoba, , Argentina
Rosario, , Argentina
Darlinghurst, , Australia
Melbourne, , Australia
Perth, , Australia
Surry Hills, , Australia
Vienna, , Austria
Antwerp, , Belgium
Brussels, , Belgium
Curitiba, , Brazil
Distrito Barao Geraldo-Campina, , Brazil
Nova Iguaçu, , Brazil
Pinheiros, , Brazil
Rio de Janeiro, , Brazil
São Paulo, , Brazil
Calgary, Alberta, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Providencia, , Chile
Santiago, , Chile
Aalborg, , Denmark
Nice, , France
Paris, , France
Rennes, , France
Villejuif, , France
Aachen, , Germany
Berlin, , Germany
Cologne, , Germany
Düsseldorf, , Germany
Hamburg, , Germany
Mannheim, , Germany
Osnabrück, , Germany
Stuttgart, , Germany
Melissia-Athens, , Greece
Guatemala City, , Guatemala
Budapest, , Hungary
Kuala Lumpur, , Malaysia
Sungai Buloh, , Malaysia
Guadalajara, , Mexico
Amsterdam, , Netherlands
Groningen, , Netherlands
Rotterdam, , Netherlands
Panama City, , Panama
Lisbon, , Portugal
Porto, , Portugal
San Juan, , Puerto Rico
Kazan', , Russia
Moscow, , Russia
Nizhny Novgorod, , Russia
Saint Petersburg, , Russia
Volgograd, , Russia
Cape Town, , South Africa
Durban, , South Africa
Houghton, Johannesburg, , South Africa
Johannesburg, , South Africa
Pretoria, , South Africa
Barcelona, , Spain
Madrid, , Spain
Zurich, , Switzerland
Bangkok, , Thailand
Khon Kaen, , Thailand
London, , United Kingdom
Countries
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References
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Madruga JV, Berger D, McMurchie M, Suter F, Banhegyi D, Ruxrungtham K, Norris D, Lefebvre E, de Bethune MP, Tomaka F, De Pauw M, Vangeneugden T, Spinosa-Guzman S; TITAN study group. Efficacy and safety of darunavir-ritonavir compared with that of lopinavir-ritonavir at 48 weeks in treatment-experienced, HIV-infected patients in TITAN: a randomised controlled phase III trial. Lancet. 2007 Jul 7;370(9581):49-58. doi: 10.1016/S0140-6736(07)61049-6.
Banhegyi D, Katlama C, da Cunha CA, Schneider S, Rachlis A, Workman C, De Meyer S, Vandevoorde A, Van De Casteele T, Tomaka F. Week 96 efficacy, virology and safety of darunavir/r versus lopinavir/r in treatment-experienced patients in TITAN. Curr HIV Res. 2012 Mar;10(2):171-81. doi: 10.2174/157016212799937218.
Other Identifiers
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TMC114-C214
Identifier Type: OTHER
Identifier Source: secondary_id
CR002794
Identifier Type: -
Identifier Source: org_study_id
NCT00980902
Identifier Type: -
Identifier Source: nct_alias
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