An Open Label Trial of TMC114/RTV in HIV-1 Infected, Treatment-experienced Subjects.

NCT00081588 | Completed Phase 2 DMC

• 2 other identifiers: CR006724TMC114-C215
• Study Type: interventional
• Target: 555
• Locations: 12 countries
• Sites: 63

Brief Summary

The primary objective of the TMC114-C215 study is to evaluate the safety and tolerability of TMC114/RTV over time. The secondary objectives are to evaluate the antiviral activity over time and to evaluate the immunological effect over time.

Conditions

HIV Infection

Keywords

TMC114-C215; Ritonavir; HIV infections; TMC114-C202; TMC114-C213

Outcome Measures

Primary Outcomes (1)

• The primary parameter is the confirmed virologic response at Week 24 (a drop in viral load (copies/mL) of at least 1 log10 versus baseline.

  24 weeks

Secondary Outcomes (1)

• Proportion of patients with a virologic response; with plasma HIV-1 RNA levels < 50 copies/mL; with plasma HIV-1 RNA levels < 400 copies/mL; Time to loss of virologic response over 144 week treatment period; Change in plasma viral load at all time points

  144 weeks

Study Arms (1)

001

EXPERIMENTAL

TMC114600/100 mg tablets of TMC114/rtv BID for 144 weeks or until commercial available

Drug: TMC114

Interventions

TMC114 DRUG

600/100 mg tablets of TMC114/rtv BID for 144 weeks or until commercial available

001

Eligibility Criteria

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

You may qualify if:

• Previous participation in the TMC114-C202 or TMC114-C213 trials
• Significant virologic failure during participation in the above trials
• Study participation in the treatment phase of the original trial for a total of at least 12 weeks before TMC114-C215 screening
• Patient agrees to take TMC114/RTV with at least 2 other antiretrovirals (NRTIs), with or without T-20, from baseline onwards
• Patient has given informed consent

You may not qualify if:

• Use of disallowed concomitant therapy
• Patient with clinical or laboratory evidence of active liver disease, liver impairment/ dysfunction or cirrhosis irrespective of liver enzyme levels
• Any active or unstable medical condition that, in the investigator's opinion, would compromise the subject's safety
• Patient with laboratory abnormalities at screening as defined by ACTG grading scheme as listed in the protocol
• Patient withdrawing consent from TMC114-C202 or TMC114-C213

Sponsors & Collaborators

• Tibotec Pharmaceuticals, Ireland: lead

Study Sites (64)

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Birmingham, Alabama, United States

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Beverly Hills, California, United States

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La Jolla, 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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Oakland, 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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Miami, 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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Springfield, Massachusetts, United States

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Camden, New Jersey, United States

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Albany, New York, United States

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New York, New York, United States

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Cincinnati, Ohio, United States

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Hershey, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Dallas, Texas, United States

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Galveston, Texas, 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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Darlinghurst, Australia

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Melbourne, Australia

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Perth, Australia

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Vienna, Austria

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Brussels, Belgium

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Ghent, Belgium

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Campinas, Brazil

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Curitiba, 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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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Le Kremlin-Bicêtre, France

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Montpellier, France

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Nantes, France

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Paris, France

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Toulon, France

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Villejuif, France

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Berlin, Germany

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Bonn, Germany

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Düsseldorf, Germany

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Essen, Germany

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Freiburg im Breisgau, Germany

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Hamburg, Germany

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Kÿln, Germany

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Mannheim, Germany

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Munich, Germany

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Budapest, Hungary

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Lisbon, Portugal

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Porto, Portugal

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Barakaldo Vizcaya S/N, Spain

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Barcelona, Spain

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Madrid, Spain

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Edinburgh, United Kingdom

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London, United Kingdom

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Manchester, United Kingdom

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Related Publications (1)

• Molina JM, Cohen C, Katlama C, Grinsztejn B, Timerman A, Pedro Rde J, Vangeneugden T, Miralles D, Meyer SD, Parys W, Lefebvre E; TMC114-C208 Study Group; TMC114-C215 Study Group. Safety and efficacy of darunavir (TMC114) with low-dose ritonavir in treatment-experienced patients: 24-week results of POWER 3. J Acquir Immune Defic Syndr. 2007 Sep 1;46(1):24-31. doi: 10.1097/QAI.0b013e3181359cfb.

  PMID: 17621237 RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

Darunavir

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

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Tibotec Pharmaceuticals Clinical Trial

  Tibotec Pharmaceutical Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2004
• First Posted: April 19, 2004
• Study Start: November 1, 2003
• Primary Completion: September 1, 2005
• Study Completion: December 1, 2008
• Last Updated: June 20, 2014

Record last verified: 2014-06

Locations

AR (1); AU (3); BR (4); PT (2); CA (3); ES (3); US (26); DE (9); FR (6); GB (3); HU (1); BE (2)