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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00540449




Registration number
NCT00540449
Ethics application status
Date submitted
4/10/2007
Date registered
8/10/2007
Date last updated
29/03/2016

Titles & IDs
Public title
TMC278-TiDP6-C209: A Clinical Trial in Treatment Naive HIV-1 Patients Comparing TMC278 to Efavirenz in Combination With Tenofovir + Emtricitabine.
Scientific title
A Phase III, Randomized, Double-blind Trial of TMC278 25 mg q.d. Versus Efavirenz 600mg q.d. in Combination With a Fixed Background Regimen Consisting of Tenofovir Disoproxil Fumarate and Emtricitabine in Antiretroviral-naive HIV-1 Infected Subjects.
Secondary ID [1] 0 0
TMC278-TIDP6-C209
Secondary ID [2] 0 0
CR002689
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
HIV-1 0 0
Human Immunodeficiency Virus Type 1 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TMC278
Treatment: Drugs - Efavirenz

Active comparator: Efavirenz - Efavirenz 600mg once daily for 96 weeks

Experimental: TMC278 - TMC278 25 mg tablet once daily for 96 weeks


Treatment: Drugs: TMC278
25 mg tablet once daily for 96 weeks

Treatment: Drugs: Efavirenz
600mg once daily for 96 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies/ml) at Week 48
Timepoint [1] 0 0
Week 48
Secondary outcome [1] 0 0
The Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies/ml) at Week 48
Timepoint [1] 0 0
Week 48
Secondary outcome [2] 0 0
Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies/ml) at Week 96
Timepoint [2] 0 0
Week 96
Secondary outcome [3] 0 0
The Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies/ml) at Week 96
Timepoint [3] 0 0
Week 96
Secondary outcome [4] 0 0
Number of Participants With Virological Response (Observed, <50 Copies/ml) at Last On-Treatment Visit (Post-Week 96).
Timepoint [4] 0 0
Variable, ranging from 3 months up to maximum 15 months for TMC278 and 12 months for Efavirenz after the 96-week visit
Secondary outcome [5] 0 0
Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies/ml) at Week 48
Timepoint [5] 0 0
Week 48
Secondary outcome [6] 0 0
Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies/ml) at Week 96
Timepoint [6] 0 0
Week 96
Secondary outcome [7] 0 0
Mean Change From Baseline to Week 48 and Week 96 in Absolute and Relative CD4+ Cell Counts (Using Imputed Data)
Timepoint [7] 0 0
Baseline, Week 48, and Week 96
Secondary outcome [8] 0 0
Number of Participants With Virologic Failure for the Resistance Determination by Emerging Resistance Associated Mutations: First Available On-Treatment Genotypic Data After Failure
Timepoint [8] 0 0
Week 96

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2011
Sample size
Target
Accrual to date
Final
694
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Darlinghurst
Recruitment hospital [2] 0 0
- Melbourne
Recruitment hospital [3] 0 0
- Perth
Recruitment hospital [4] 0 0
- Surry Hills
Recruitment postcode(s) [1] 0 0
- Darlinghurst
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment postcode(s) [3] 0 0
- Perth
Recruitment postcode(s) [4] 0 0
- Surry Hills
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arizona
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United States of America
State/province [3] 0 0
California
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District of Columbia
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Florida
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Georgia
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Illinois
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Maryland
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New Jersey
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New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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South Carolina
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Texas
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Washington
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Cordoba
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Argentina
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Guernica
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Austria
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Innsbruck
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Austria
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Vienna
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Austria
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Wien
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Brazil
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Curitiba
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Brazil
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Nova Iguacu
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Brazil
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Rio De Janeiro
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Brazil
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Salvador
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Brazil
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Sao Paulo
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Canada
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Ontario
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Canada
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Quebec
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Denmark
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Copenhagen
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Denmark
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Hvidovre N/A
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Denmark
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Odense N/A
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France
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Loire
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France
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Lyon
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France
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Paris Cedex 10
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France
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Paris Cedex 12
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France
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Paris
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France
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Tourcoing
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Ciudad De Mexico
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Mexico
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Zapopan
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Netherlands
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Rotterdam
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Portugal
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Amadora
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Portugal
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Lisboa
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Portugal
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Portimao
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Portugal
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Porto
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Puerto Rico
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San Juan
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Romania
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Bucuresti
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Romania
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Iasi
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Romania
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Timisoara
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Russian Federation
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Krasnodar
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Russian Federation
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St Petersburg
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South Africa
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Bloemfontein
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South Africa
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Cape Town
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South Africa
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Durban N/A
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South Africa
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Houghton, Johannesburg
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South Africa
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Johannesburg
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South Africa
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Pretoria N/A
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Spain
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Alicante
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Spain
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Barcelona
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Spain
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Madrid
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Sweden
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Göteborg
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Sweden
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Malmö
Country [66] 0 0
Sweden
State/province [66] 0 0
Stockholm
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Taiwan
State/province [67] 0 0
Kaohsiung County
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Taiwan
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Kaohsiung
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Taiwan
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Tainan
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Taiwan
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Taipei
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Thailand
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Bangkok
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Thailand
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Chiang Mai
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Thailand
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Khon Kaen
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United Kingdom
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Birmingham
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United Kingdom
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Brighton
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United Kingdom
State/province [76] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Tibotec Pharmaceuticals, Ireland
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00540449
Trial related presentations / publications
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Tibotec Pharmaceuticals Clinical Trial
Address 0 0
Tibotec Pharmaceutical Limited
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00540449