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.

NCT00258557 | Completed Phase 3 DMC

• 2 other identifiers: CR002800TMC114-C211
• Study Type: interventional
• Target: 692
• Locations: 24 countries
• Sites: 88

Brief Summary

The purpose of this study is to compare the efficacy, safety and tolerability of TMC114/r versus Kaletra (a combination pill of lopinavir and ritonavir, ("lpv/rtv") in HIV-1 infected patients who have never been treated with anti-retroviral medications (referred to as "treatment-naïve" patients).

Conditions

HIV

Keywords

HIV; Anti-Retroviral agents; HIV-1; TMC114/r; Treatment naïve patients

Outcome Measures

Primary Outcomes (1)

• Confirmed Virologic Response defined as a Viral Load < 50 copies/mL at Week 48

  48 weeks

Secondary Outcomes (1)

• Evaluation of safety, tolerability, and durability of efficacy over 96 weeks of treatment

  192 weeks

Study Arms (2)

002

EXPERIMENTAL

TMC-114/RTV two 400 mg tablets of TMC114 + one 100 mg capsule of RTV daily for max. 192 weeks

Drug: TMC-114/RTV

001

ACTIVE COMPARATOR

LPV/RTV 400/100 mg twice daily or 800/200 mg daily depending on the country for max. 192 weeks

Drug: LPV/RTV

Interventions

LPV/RTV DRUG

400/100 mg twice daily or 800/200 mg daily depending on the country for max. 192 weeks

001

TMC-114/RTV DRUG

two 400 mg tablets of TMC114 + one 100 mg capsule of RTV daily for max. 192 weeks

002

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with documented HIV-1 infection
• 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.

You may not qualify if:

• Presence of any currently active AIDS defining illness or receiving treatment for primary HIV infection
• 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

Sponsors & Collaborators

• Tibotec Pharmaceuticals, Ireland: lead

Study Sites (89)

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Phoenix, Arizona, United States

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Beverly Hills, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Sacramento, California, United States

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San Francisco, California, United States

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Washington D.C., District of Columbia, United States

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Fort Lauderdale, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Miami Beach, Florida, United States

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Orlando, Florida, United States

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Safety Harbor, Florida, United States

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Tampa, Florida, United States

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Vero Beach, Florida, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Las Vegas, Nevada, United States

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Brooklyn, New York, United States

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Chapel Hill, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Philadelphia, Pennsylvania, United States

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Columbia, South Carolina, United States

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Houston, Texas, United States

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Buenos Aires, Argentina

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Mar del Plata, Argentina

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Neuquén, Argentina

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Brisbane, Australia

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Darlinghurst, Australia

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Surry Hills, Australia

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Westmead, Australia

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Vienna, Austria

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Brussels, Belgium

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Ghent, Belgium

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Leuven, Belgium

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Vancouver, British Columbia, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Providencia, Chile

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Santiago, Chile

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Costa Rica, Costa Rica

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San José, Costa Rica

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Aalborg, Denmark

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Copenhagen Ø, Denmark

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Hvidovre, Denmark

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Bobigny, France

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Lyon, France

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Nice, France

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Orléans, France

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Paris, France

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Berlin, Germany

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Cologne, Germany

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Erlangen, Germany

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Freiburg im Breisgau, Germany

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Hamburg, Germany

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Mannheim, Germany

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Munich, Germany

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München, Germany

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Athens, Greece

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Guatemala City, Guatemala

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Sungai Buloh, Malaysia

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Del Tlalpan, Mexico

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Guadalajara, Mexico

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Mex Ctity, Mexico

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Mexico City, Mexico

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Panama City, Panama

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San Juan, Puerto Rico

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Kazan', Russia

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Krasnodar, Russia

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Moscow, Russia

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Saint Petersburg, Russia

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Smolensk, Russia

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Volgograd, Russia

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Voronezh, Russia

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Singapore, Singapore

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Cape Town, South Africa

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Dundee, South Africa

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Johannesburg, South Africa

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Pretoria, South Africa

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Barcelona, Spain

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Zurich, Switzerland

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Taipei, Taiwan

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Tiachung, Taiwan

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Bangkok, Thailand

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Chiang Mai, Thailand

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Khon Kaen, Thailand

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Brighton, United Kingdom

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London, United Kingdom

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Related Publications (2)

• 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.

  PMID: 19487905 RESULT

• 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.

  PMID: 23088336 DERIVED

Related Links

• 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.

Study Officials

• Tibotec Pharmaceuticals Clinical Trial

  Tibotec Pharmaceutical Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2005
• First Posted: November 24, 2005
• Study Start: September 1, 2005
• Primary Completion: June 1, 2007
• Study Completion: May 1, 2012
• Last Updated: June 26, 2013

Record last verified: 2013-06

Locations

MY (1); DK (3); SG (1); DE (8); CA (4); AU (4); US (24); FR (5); PR (1); CH (1); GU (1); ES (1); AR (3); TW (2); RU (7); CL (2); CO (2); BE (3); TH (3); GR (1); GB (2); ME (4); PA (1); ZA (4)