TMC114-C214: Trial of TMC114 Administered With Low Dose Ritonavir (RTV) in HIV-1 Infected Treatment Experienced Patients

NCT00110877 | Completed Phase 3 DMC

• 2 other identifiers: CR002794TMC114-C214
• Study Type: interventional
• Target: 604
• Locations: 25 countries
• Sites: 102

Brief Summary

Study TMC114-C214 is a randomized, controlled, open-label trial to compare the efficacy, safety and tolerability of TMC114 boosted with low dose ritonavir (RTV) versus Kaletra (LPV)/RTV in lopinavir-naïve treatment-experienced HIV-1 infected patients.

Conditions

HIV Infection

Keywords

Human Immunodeficiency Virus; Treatment Experienced; TMC114-C214

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Viral load <400 copies/mL per TLOVR algorithm at Week 48 (Per Protocol Population)

  48 weeks

Secondary Outcomes (2)

• Number of Participants with Adverse Events

  96 weeks

• Number of Participants With Viral load <400 copies/mL per TLOVR Algorithm at Week 96 (Per Protocol Population)

  96 Weeks

Study Arms (2)

002

EXPERIMENTAL

LPV/rtv One 400mg LPV tablet twice daily with 100mg RTV

Drug: LPV/rtv

001

EXPERIMENTAL

TMC114/rtv Two 300mg TMC114 tablets twice daily with 100mg RTV

Drug: TMC114/rtv

Interventions

LPV/rtv DRUG

One 400mg LPV tablet twice daily with 100mg RTV

002

TMC114/rtv DRUG

Two 300mg TMC114 tablets twice daily with 100mg RTV

001

Eligibility Criteria

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

You may qualify if:

• Patient has documented HIV-1 infection
• 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

You may not qualify if:

• Patients for whom an investigational Antiretroviral is part of the current regimen, with the following exceptions if applicable (depending on local regulatory approval)
• 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

Sponsors & Collaborators

• Tibotec Pharmaceuticals, Ireland: lead

Study Sites (103)

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Phoenix, Arizona, United States

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Little Rock, Arkansas, 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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San Francisco, California, United States

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West Hollywood, California, United States

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Denver, Colorado, 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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Miami, 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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Atlanta, Georgia, United States

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Macon, Georgia, United States

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Chicago, Illinois, United States

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Boston, Massachusetts, United States

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Berkley, Michigan, United States

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Camden, New Jersey, United States

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East Orange, New Jersey, United States

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Newark, New Jersey, United States

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The Bronx, New York, United States

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Durham, North Carolina, United States

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Huntersville, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cleveland, Ohio, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Columbia, South Carolina, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Galveston, Texas, United States

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Houston, Texas, United States

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Longview, Texas, United States

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Hampton, Virginia, United States

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Seattle, Washington, United States

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Milwaukee, Wisconsin, United States

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Buenos Aires, Argentina

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Córdoba, Argentina

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Rosario, Argentina

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Darlinghurst, Australia

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Melbourne, Australia

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Perth, Australia

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Surry Hills, Australia

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Vienna, Austria

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Antwerp, Belgium

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Brussels, Belgium

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Curitiba, Brazil

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Distrito Barao Geraldo-Campina, Brazil

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Nova Iguaçu, Brazil

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Pinheiros, Brazil

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Rio de Janeiro, Brazil

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São Paulo, Brazil

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Calgary, Alberta, 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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Aalborg, Denmark

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Nice, France

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Paris, France

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Rennes, France

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Villejuif, France

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Aachen, Germany

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Berlin, Germany

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Cologne, Germany

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Düsseldorf, Germany

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Hamburg, Germany

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Mannheim, Germany

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Osnabrück, Germany

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Stuttgart, Germany

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Melissia-Athens, Greece

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Guatemala City, Guatemala

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Budapest, Hungary

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Kuala Lumpur, Malaysia

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Sungai Buloh, Malaysia

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Guadalajara, Mexico

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Amsterdam, Netherlands

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Groningen, Netherlands

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Rotterdam, Netherlands

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Panama City, Panama

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Lisbon, Portugal

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Porto, Portugal

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San Juan, Puerto Rico

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Kazan', Russia

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Moscow, Russia

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Nizhny Novgorod, Russia

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Saint Petersburg, Russia

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Volgograd, Russia

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Cape Town, South Africa

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Durban, South Africa

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Houghton, Johannesburg, 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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Madrid, Spain

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Zurich, Switzerland

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Bangkok, Thailand

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Khon Kaen, Thailand

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London, United Kingdom

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Related Publications (2)

• 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.

  PMID: 17617272 RESULT

• 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.

  PMID: 22339125 DERIVED

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

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: May 13, 2005
• First Posted: May 16, 2005
• Study Start: April 1, 2005
• Primary Completion: January 1, 2007
• Study Completion: October 1, 2011
• Last Updated: July 3, 2015

Record last verified: 2015-07

Locations

DK (1); ES (2); BE (2); CL (2); GB (1); FR (4); ME (1); PA (1); RU (5); NL (3); HU (1); ZA (5); PT (2); CH (1); AU (4); TH (2); GU (1); BR (6); MY (2); US (39); AR (3); GR (1); CA (4); DE (8); PR (1)