TMC278-TiDP6-C209: A Clinical Trial in Treatment Naive HIV-1 Patients Comparing TMC278 to Efavirenz in Combination With Tenofovir + Emtricitabine.

NCT00540449 | Completed Phase 3 Results DMC

• 2 other identifiers: CR002689TMC278-TIDP6-C209
• Study Type: interventional
• Target: 694
• Locations: 19 countries
• Sites: 90

Brief Summary

The purpose of this trial is to compare the effectiveness, safety and tolerability of TMC278 given at a dose of 25 mg once daily versus efavirenz (EFV) at a dose of 600 mg once daily, when combined with a fixed background regimen consisting of emtricitabine (FTC) + tenofovir disoproxil fumarate (TDF), in HIV-1 infected patients who have not yet taken any anti-HIV drugs. The following evaluations will be done: antiviral activity, immunologic changes, and viral geno-/phenotype evolution, relationship of Pharmacokinetics (PK) and PK/Pharmacodynamics, medical resource utilization and treatment adherence.

Conditions

HIV Infections; HIV-1; Human Immunodeficiency Virus Type 1

Keywords

TMC278-C209; Antiretroviral; Non-nucleoside reverse transcriptase inhibitor; HIV-1; AIDS; TMC278-TiDP6-C209; Treatment Naive

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies/ml) at Week 48

  Virological response is defined as confirmed plasma viral load less than (\<) 50 human immunodeficiency virus-1 (HIV-1) (ribonucleic acid \[RNA\]) copies/milliliter (ml) at Week 48. The TLOVR algorithm was used to derive response. Response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Resuppression after confirmed virologic failure was considered as failure. Virologic Failure includes participants who were rebounder (confirmed viral load \>= 50 copies/ml after being responder) or who were never suppressed (no confirmed viral load \<50 copies/ml).

  Week 48

Secondary Outcomes (8)

• The Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies/ml) at Week 48

  Week 48

• Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies/ml) at Week 96

  Week 96

• The Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies/ml) at Week 96

  Week 96

• Number of Participants With Virological Response (Observed, <50 Copies/ml) at Last On-Treatment Visit (Post-Week 96).

  Variable, ranging from 3 months up to maximum 15 months for TMC278 and 12 months for Efavirenz after the 96-week visit

• Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies/ml) at Week 48

  Week 48

Study Arms (2)

Efavirenz

ACTIVE COMPARATOR

Efavirenz 600mg once daily for 96 weeks

Drug: Efavirenz

TMC278

EXPERIMENTAL

TMC278 25 mg tablet once daily for 96 weeks

Drug: TMC278

Interventions

TMC278 DRUG

25 mg tablet once daily for 96 weeks

TMC278

Efavirenz DRUG

600mg once daily for 96 weeks

Efavirenz

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with documented HIV-1 infection
• Patient has never been treated with a therapeutic HIV vaccine or an ARV drug prior to screening
• Patient's HIV-1 plasma viral load at screening is \> 5,000 HIV-1 RNA copies/mL (assayed by RNA PCR standard specimen procedure)
• Patient's virus is sensitive to TDF and FTC
• Patient agrees not to start ART (antiretroviral treatment) before the baseline visit

You may not qualify if:

• Previous use of ANY ARV drug for ANY length of time
• Any documented evidence of NNRTI resistance associated mutations in patient's HIV
• Category C AIDS defining illness, except: stable Kaposi Sarcoma, wasting syndrome if not progressive
• Pneumocystis carinii pneumonia (PCP) that is considered not cured
• Active TB
• Allergy or hypersensitivity to study or background ARTs
• Specific grade 3 or 4 toxicity
• Kidney impairment: calculated creatinine clearance \<50 ml/min

Sponsors & Collaborators

• Tibotec Pharmaceuticals, Ireland: lead

Study Sites (92)

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Birmingham, Alabama, United States

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Phoenix, Arizona, United States

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Beverly Hills, California, United States

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Los Angeles, California, United States

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Newport Beach, California, United States

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Sacramento, 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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Tampa, Florida, United States

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Vero Beach, Florida, United States

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West Palm Beach, Florida, United States

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Macon, Georgia, United States

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Chicago, Illinois, United States

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Baltimore, Maryland, United States

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Newark, New Jersey, United States

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Albany, New York, United States

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Buffalo, New York, United States

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New York, New York, United States

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Chapel Hill, North Carolina, United States

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Durham, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Akron, Ohio, United States

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Cincinnati, Ohio, United States

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Columbus, 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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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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Guernica, 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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Innsbruck, Austria

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Vienna, Austria

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Curitiba, Brazil

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Nova Iguaçu, Brazil

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Rio de Janeiro, Brazil

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Salvador, Brazil

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São Paulo, Brazil

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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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Copenhagen, Denmark

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Hvidovre, Denmark

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Odense, Denmark

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Loiré, France

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Lyon, France

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Paris, France

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Tourcoing, France

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Villejuif, France

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Mexico City, Mexico

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Zapopan, Mexico

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Rotterdam, Netherlands

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Amadora, Portugal

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Lisbon, Portugal

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Portimão, Portugal

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Porto, Portugal

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San Juan, Puerto Rico

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Bucharest, Romania

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Iași, Romania

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Timișoara, Romania

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Krasnodar, Russia

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Saint Petersburg, Russia

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Bloemfontein, South Africa

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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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Alicante, Spain

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Barcelona, Spain

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Madrid, Spain

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Gothenburg, Sweden

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Malmo, Sweden

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Stockholm, Sweden

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Kaohsiung City, Taiwan

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Kaohsiung County, Taiwan

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Tainan, Taiwan

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Taipei, 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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Birmingham, United Kingdom

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Brighton, United Kingdom

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London, United Kingdom

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Related Publications (3)

• Rimsky L, Van Eygen V, Hoogstoel A, Stevens M, Boven K, Picchio G, Vingerhoets J. 96-Week resistance analyses of rilpivirine in treatment-naive, HIV-1-infected adults from the ECHO and THRIVE Phase III trials. Antivir Ther. 2013;18(8):967-77. doi: 10.3851/IMP2636. Epub 2013 May 28.

  PMID: 23714781 DERIVED

• Nelson M, Amaya G, Clumeck N, Arns da Cunha C, Jayaweera D, Junod P, Li T, Tebas P, Stevens M, Buelens A, Vanveggel S, Boven K; ECHO and THRIVE Study Groups. Efficacy and safety of rilpivirine in treatment-naive, HIV-1-infected patients with hepatitis B virus/hepatitis C virus coinfection enrolled in the Phase III randomized, double-blind ECHO and THRIVE trials. J Antimicrob Chemother. 2012 Aug;67(8):2020-8. doi: 10.1093/jac/dks130. Epub 2012 Apr 24.

  PMID: 22532465 DERIVED

• Molina JM, Cahn P, Grinsztejn B, Lazzarin A, Mills A, Saag M, Supparatpinyo K, Walmsley S, Crauwels H, Rimsky LT, Vanveggel S, Boven K; ECHO study group. Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naive adults infected with HIV-1 (ECHO): a phase 3 randomised double-blind active-controlled trial. Lancet. 2011 Jul 16;378(9787):238-46. doi: 10.1016/S0140-6736(11)60936-7.

  PMID: 21763936 DERIVED

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Rilpivirine; efavirenz

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

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Leader
• Organization: Janssen Infectious Diseases BVBA

ClinicalTrialDisclosure@its.jnj.com

Study Officials

• Tibotec Pharmaceuticals Clinical Trial

  Tibotec Pharmaceutical Limited

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2007
• First Posted: October 8, 2007
• Study Start: May 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: December 1, 2011
• Last Updated: March 29, 2016
• Results First Posted: July 11, 2011

Record last verified: 2016-02

Locations

AU (4); ES (3); CA (3); NL (1); BR (5); PR (1); ZA (6); AR (3); SE (3); GB (3); PT (4); DK (3); TW (4); US (32); TH (3); RO (3); RU (2); FR (5); ME (2)