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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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.
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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.
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Secondary ID [1]
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TMC278-TIDP6-C209
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Secondary ID [2]
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CR002689
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HIV Infections
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HIV-1
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Human Immunodeficiency Virus Type 1
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Condition category
Condition code
Infection
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0
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Acquired immune deficiency syndrome (AIDS / HIV)
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies/ml) at Week 48
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Assessment method [1]
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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).
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Timepoint [1]
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Week 48
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Secondary outcome [1]
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The Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies/ml) at Week 48
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Assessment method [1]
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The analysis is based on the last observed viral load (VL) data within the Week 48 window. Virologic response is defined as a VL<50 copies/ml (observed case). Missing VL was considered as non-response. Virologic Failure includes subjects who had VL>=50 copies/ml in the Wk48 window, subjects who discontinued early due to lack or loss of efficacy, subjects who discontinued for reasons other than an adverse event, death or lack or loss of efficacy and at the time of discontinuation had a VL>=50 copies/ml and subjects who had a switch in background regimen that was not permitted by the protocol.
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Timepoint [1]
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Week 48
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Secondary outcome [2]
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Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies/ml) at Week 96
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Assessment method [2]
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Timepoint [2]
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Week 96
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Secondary outcome [3]
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The Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies/ml) at Week 96
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Assessment method [3]
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Timepoint [3]
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Week 96
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Secondary outcome [4]
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Number of Participants With Virological Response (Observed, <50 Copies/ml) at Last On-Treatment Visit (Post-Week 96).
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Assessment method [4]
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Virological response is defined as (observed) plasma viral load less than 50 human immunodeficiency virus-type 1 (HIV-1) ribonucleic acid (RNA) copies per ml at the last on-treatment visit (post-Week 96).
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Timepoint [4]
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Variable, ranging from 3 months up to maximum 15 months for TMC278 and 12 months for Efavirenz after the 96-week visit
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Secondary outcome [5]
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Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies/ml) at Week 48
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Assessment method [5]
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Timepoint [5]
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Week 48
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Secondary outcome [6]
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Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies/ml) at Week 96
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Assessment method [6]
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Timepoint [6]
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Week 96
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Secondary outcome [7]
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Mean Change From Baseline to Week 48 and Week 96 in Absolute and Relative CD4+ Cell Counts (Using Imputed Data)
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Assessment method [7]
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Change from baseline in CD4+ cell count was imputed in case of missing values: in case of premature discontinuation, data were imputed with the baseline value after discontinuation (i.e. change=0, Non-Completer [NC] = Failure); otherwise last observation carried forward was applied.
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Timepoint [7]
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Baseline, Week 48, and Week 96
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Secondary outcome [8]
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Number of Participants With Virologic Failure for the Resistance Determination by Emerging Resistance Associated Mutations: First Available On-Treatment Genotypic Data After Failure
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Assessment method [8]
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Virologic failure for the resistance determinations was defined as lack of virologic response (never having had 2 consecutive plasma viral load <50 copies/mL) and plasma viral load increase of >=0.5 log 10 copies/mL above nadir (i.e., never suppressed), or confirmed loss of virologic response (2 consecutive plasma viral load >=50 copies/mL after having had 2 consecutive plasma viral load <50 copies/mL; i.e., rebounder), or discontinued with a last observed on-treatment plasma viral load >=50 copies/mL after having had 2 consecutive plasma viral load <50 copies/mL. For this study, treatment-emergent reverse transcriptase (RT) resistance associated mutations (RAMs) occurring in at least 2 virologic failures (for at least one treatment group) for the following lists are presented: i) Extended list of Non-nucleoside reverse transcriptase inhibitor (NNRTI RAMs) ii) IAS-USA list of Nucleoside/tide reverse transcriptase inhibitor (N[t]RTI RAMs).
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Timepoint [8]
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Week 96
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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
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Minimum age
18
Years
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Maximum age
99
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2011
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Sample size
Target
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Accrual to date
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Final
694
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Darlinghurst
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- Melbourne
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- Perth
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Recruitment hospital [4]
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- Surry Hills
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- Darlinghurst
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- Melbourne
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- Perth
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Recruitment postcode(s) [4]
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- Surry Hills
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Recruitment outside Australia
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United States of America
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Alabama
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Chiang Mai
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Khon Kaen
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United Kingdom
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Birmingham
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Brighton
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Tibotec Pharmaceuticals, Ireland
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Address
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00540449
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Tibotec Pharmaceuticals Clinical Trial
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Address
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Tibotec Pharmaceutical Limited
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00540449
Download to PDF