TMC114-C211: Trial of an Investigational Protease Inhibitor TMC114 With Ritonavir ("TMC114/r") in HIV-1 Infected Patients Who Have Never Been Treated With Antiretroviral Medications.
NCT ID: NCT00258557
Last Updated: 2013-06-26
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
692 participants
INTERVENTIONAL
2005-09-30
2012-05-31
Brief Summary
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Detailed Description
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The primary efficacy parameter is virologic response defined as a confirmed viral load \< 50 copies/mL at Week 48 the objective of this study is to establish non-inferiority of TMC114/r versus lpv/rtv in terms of virologic response at Week 48 using a non-inferiority margin of 12%. To test this hypothesis, a two-sided 95% confidence interval (CI) of the difference in response rate between TMC114/r and lpv/rtv will be derived: If the lower bound of the CI exceeds -12%, non-inferiority will be concluded. Patients will take oral doses for up to 96 weeks of either 800/100mg of TMC114/r 1x/day or 800/200mg of lpv/rtv once daily, each in combination with TDF/FTC. (The 400/100 mg 2x/day dose of lpv/rtv will be used where the 1x/day use of lpv/rtv is not approved).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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002
TMC-114/RTV two 400 mg tablets of TMC114 + one 100 mg capsule of RTV daily for max. 192 weeks
TMC-114/RTV
two 400 mg tablets of TMC114 + one 100 mg capsule of RTV daily for max. 192 weeks
001
LPV/RTV 400/100 mg twice daily or 800/200 mg daily depending on the country for max. 192 weeks
LPV/RTV
400/100 mg twice daily or 800/200 mg daily depending on the country for max. 192 weeks
Interventions
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LPV/RTV
400/100 mg twice daily or 800/200 mg daily depending on the country for max. 192 weeks
TMC-114/RTV
two 400 mg tablets of TMC114 + one 100 mg capsule of RTV daily for max. 192 weeks
Eligibility Criteria
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Inclusion Criteria
* Screening plasma HIV-1 RNA \>= 5000 copies/mL
* Patients qualify for treatment initiation based on the investigator's assessments and/or according to treatment guidelines
* Patients who can comply with the protocol requirements
* General medical condition, in the investigator's opinion, does not interfere with the assessments and the completion of the trial.
Exclusion Criteria
* Life expectancy of less than 6 months
* Previous or current use of antiretroviral medications (ARVs) for the treatment of HIV-infection or hepatitis B infection with anti-HIV activity
* Female -patients who are pregnant or breast-feeding, or are of childbearing potential without use of effective non-hormonal birth control methods or not willing to continue practicing these birth control methods for at least 30 days after the end of the treatment period
* -patients with a grade 3 or 4 laboratory abnormality as defined by DAIDS grading, or a calculated creatinine clearance (CLCr) \< 70 mL/min
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
Beverly Hills, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Sacramento, California, United States
San Francisco, California, United States
Washington D.C., District of Columbia, United States
Fort Lauderdale, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Miami Beach, Florida, United States
Orlando, Florida, United States
Safety Harbor, Florida, United States
Tampa, Florida, United States
Vero Beach, Florida, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Las Vegas, Nevada, United States
Brooklyn, New York, United States
Chapel Hill, North Carolina, United States
Winston-Salem, North Carolina, United States
Philadelphia, Pennsylvania, United States
Columbia, South Carolina, United States
Houston, Texas, United States
Buenos Aires, , Argentina
Mar del Plata, , Argentina
Neuquén, , Argentina
Brisbane, , Australia
Darlinghurst, , Australia
Surry Hills, , Australia
Westmead, , Australia
Vienna, , Austria
Brussels, , Belgium
Ghent, , Belgium
Leuven, , Belgium
Vancouver, British Columbia, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Providencia, , Chile
Santiago, , Chile
Costa Rica, , Costa Rica
San José, , Costa Rica
Aalborg, , Denmark
Copenhagen Ø, , Denmark
Hvidovre, , Denmark
Bobigny, , France
Lyon, , France
Nice, , France
Orléans, , France
Paris, , France
Berlin, , Germany
Cologne, , Germany
Erlangen, , Germany
Freiburg im Breisgau, , Germany
Hamburg, , Germany
Mannheim, , Germany
Munich, , Germany
München, , Germany
Athens, , Greece
Guatemala City, , Guatemala
Sungai Buloh, , Malaysia
Del Tlalpan, , Mexico
Guadalajara, , Mexico
Mex Ctity, , Mexico
Mexico City, , Mexico
Panama City, , Panama
San Juan, , Puerto Rico
Kazan', , Russia
Krasnodar, , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Smolensk, , Russia
Volgograd, , Russia
Voronezh, , Russia
Singapore, , Singapore
Cape Town, , South Africa
Dundee, , South Africa
Johannesburg, , South Africa
Pretoria, , South Africa
Barcelona, , Spain
Zurich, , Switzerland
Taipei, , Taiwan
Tiachung, , Taiwan
Bangkok, , Thailand
Chiang Mai, , Thailand
Khon Kaen, , Thailand
Brighton, , United Kingdom
London, , United Kingdom
Countries
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References
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Mills AM, Nelson M, Jayaweera D, Ruxrungtham K, Cassetti I, Girard PM, Workman C, Dierynck I, Sekar V, Abeele CV, Lavreys L. Once-daily darunavir/ritonavir vs. lopinavir/ritonavir in treatment-naive, HIV-1-infected patients: 96-week analysis. AIDS. 2009 Aug 24;23(13):1679-88. doi: 10.1097/QAD.0b013e32832d7350.
Orkin C, DeJesus E, Khanlou H, Stoehr A, Supparatpinyo K, Lathouwers E, Lefebvre E, Opsomer M, Van de Casteele T, Tomaka F. Final 192-week efficacy and safety of once-daily darunavir/ritonavir compared with lopinavir/ritonavir in HIV-1-infected treatment-naive patients in the ARTEMIS trial. HIV Med. 2013 Jan;14(1):49-59. doi: 10.1111/j.1468-1293.2012.01060.x. Epub 2012 Oct 23.
Related Links
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Phase III randomized, controlled, open-label trial to investigate the antiviral activity, tolerability and safety of TMC114/r in treatment- naive HIV-1 infected patients.
Phase III randomized, controlled, open-label trial to investigate the antiviral activity, tolerability and safety of TMC114/r in treatment- naive HIV-1 infected patients.
Other Identifiers
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TMC114-C211
Identifier Type: OTHER
Identifier Source: secondary_id
CR002800
Identifier Type: -
Identifier Source: org_study_id
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