Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00543725
Registration number
NCT00543725
Ethics application status
Date submitted
11/10/2007
Date registered
15/10/2007
Date last updated
1/04/2016
Titles & IDs
Public title
TMC278-TiDP6-C215: A Clinical Trial in Treatment Naive HIV-subjects Patients Comparing TMC278 to Efavirenz in Combination With 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors
Query!
Scientific title
A Phase III, Randomized, Double-blind Trial of TMC278 25mg q.d. Versus Efavirenz 600mg q.d. in Combination With a Background Regimen Containing 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Antiretroviral-naive HIV-1 Infected Subjects.
Query!
Secondary ID [1]
0
0
TMC278-TIDP6-C215
Query!
Secondary ID [2]
0
0
CR002704
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
HIV Infections
0
0
Query!
HIV-1
0
0
Query!
Condition category
Condition code
Infection
0
0
0
0
Query!
Acquired immune deficiency syndrome (AIDS / HIV)
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - TMC278
Treatment: Drugs - efavirenz
Active Comparator: 002 - efavirenz 600 mg tablet once daily for 96 weeks
Experimental: 001 - TMC278 25 mg tablet once daily for 96 weeks
Treatment: Drugs: TMC278
25 mg tablet once daily for 96 weeks
Treatment: Drugs: efavirenz
600 mg tablet once daily for 96 weeks
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 48
Query!
Assessment method [1]
0
0
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).
Query!
Timepoint [1]
0
0
Week 48
Query!
Secondary outcome [1]
0
0
Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies Per mL) at Week 48
Query!
Assessment method [1]
0
0
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 Wk 48 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.
Query!
Timepoint [1]
0
0
Week 48
Query!
Secondary outcome [2]
0
0
Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 96
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
Week 96
Query!
Secondary outcome [3]
0
0
Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies Per mL) at Week 96
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
Week 96
Query!
Secondary outcome [4]
0
0
Number of Participants With Virological Response (Observed, <50 Copies/mL) at Last On-Treatment Visit (Post-Week 96).
Query!
Assessment method [4]
0
0
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 post-Week 96 visit.
Query!
Timepoint [4]
0
0
Variable, ranging from 3 months up to maximum 18 months for TMC278 and 12 months for Efavirenz
Query!
Secondary outcome [5]
0
0
Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies Per mL) at Week 48
Query!
Assessment method [5]
0
0
Virological response is defined as confirmed plasma viral load < 400 HIV-1 (RNA) copies/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 >= 400 copies/mL after being responder) or who were never suppressed (no confirmed viral load <400 copies/mL).
Query!
Timepoint [5]
0
0
Week 48
Query!
Secondary outcome [6]
0
0
Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies Per mL) at Week 96
Query!
Assessment method [6]
0
0
Virological response is defined as confirmed plasma viral load < 400 HIV-1 (RNA) copies/mL at Week 96. 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 >= 400 copies/mL after being responder) or who were never suppressed (no confirmed viral load <400 copies/mL).
Query!
Timepoint [6]
0
0
Week 96
Query!
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)
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
Baseline, Week 48, and Week 96
Query!
Secondary outcome [8]
0
0
Number of Participants With Virologic Failure for the Resistance Determinations by Developing Mutations: First Available On-Treatment Genotypic Data After Failure
Query!
Assessment method [8]
0
0
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).
Query!
Timepoint [8]
0
0
Week 96
Query!
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 the 2 nucleoside/nucleotide reverse transcriptase
inhibitors chosen for treatment
- Patient agrees not to start ART before the baseline visit
- Patient is HLA-B*5701 negative in case abacavir is included in the patient's treatment
regimen.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
99
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/06/2008
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/02/2012
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
680
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
- Darlinghurst
Query!
Recruitment hospital [2]
0
0
- Prahran
Query!
Recruitment hospital [3]
0
0
- Surry Hills
Query!
Recruitment postcode(s) [1]
0
0
- Darlinghurst
Query!
Recruitment postcode(s) [2]
0
0
- Prahran
Query!
Recruitment postcode(s) [3]
0
0
- Surry Hills
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
District of Columbia
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Illinois
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Kentucky
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Maryland
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Massachusetts
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Michigan
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Minnesota
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
New Jersey
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
New York
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Pennsylvania
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Texas
Query!
Country [14]
0
0
Belgium
Query!
State/province [14]
0
0
Antwerpen
Query!
Country [15]
0
0
Belgium
Query!
State/province [15]
0
0
Brussels
Query!
Country [16]
0
0
Belgium
Query!
State/province [16]
0
0
Gent
Query!
Country [17]
0
0
Belgium
Query!
State/province [17]
0
0
Leuven
Query!
Country [18]
0
0
Brazil
Query!
State/province [18]
0
0
Campinas
Query!
Country [19]
0
0
Brazil
Query!
State/province [19]
0
0
Distrito Barao Geraldo-Campina
Query!
Country [20]
0
0
Brazil
Query!
State/province [20]
0
0
Pinheiros
Query!
Country [21]
0
0
Brazil
Query!
State/province [21]
0
0
Recife
Query!
Country [22]
0
0
Brazil
Query!
State/province [22]
0
0
Sao Paulo
Query!
Country [23]
0
0
Canada
Query!
State/province [23]
0
0
Alberta
Query!
Country [24]
0
0
Canada
Query!
State/province [24]
0
0
British Columbia
Query!
Country [25]
0
0
Canada
Query!
State/province [25]
0
0
Manitoba
Query!
Country [26]
0
0
Canada
Query!
State/province [26]
0
0
Ontario
Query!
Country [27]
0
0
Canada
Query!
State/province [27]
0
0
Quebec
Query!
Country [28]
0
0
Chile
Query!
State/province [28]
0
0
Providencia
Query!
Country [29]
0
0
Chile
Query!
State/province [29]
0
0
Santiago
Query!
Country [30]
0
0
China
Query!
State/province [30]
0
0
Beijing
Query!
Country [31]
0
0
China
Query!
State/province [31]
0
0
Guangzhou
Query!
Country [32]
0
0
China
Query!
State/province [32]
0
0
Shanghai
Query!
Country [33]
0
0
Costa Rica
Query!
State/province [33]
0
0
San Jose
Query!
Country [34]
0
0
France
Query!
State/province [34]
0
0
Clamart
Query!
Country [35]
0
0
France
Query!
State/province [35]
0
0
Le Kremlin Bicetre
Query!
Country [36]
0
0
France
Query!
State/province [36]
0
0
Montpellier
Query!
Country [37]
0
0
France
Query!
State/province [37]
0
0
Paris
Query!
Country [38]
0
0
Germany
Query!
State/province [38]
0
0
Berlin
Query!
Country [39]
0
0
Germany
Query!
State/province [39]
0
0
Essen
Query!
Country [40]
0
0
Germany
Query!
State/province [40]
0
0
Frankfurt
Query!
Country [41]
0
0
Germany
Query!
State/province [41]
0
0
Hamburg
Query!
Country [42]
0
0
Germany
Query!
State/province [42]
0
0
Hannover
Query!
Country [43]
0
0
Germany
Query!
State/province [43]
0
0
Köln
Query!
Country [44]
0
0
Germany
Query!
State/province [44]
0
0
Mannheim
Query!
Country [45]
0
0
India
Query!
State/province [45]
0
0
Chennai
Query!
Country [46]
0
0
India
Query!
State/province [46]
0
0
Nagpur
Query!
Country [47]
0
0
Mexico
Query!
State/province [47]
0
0
Guadalajara N/A
Query!
Country [48]
0
0
Mexico
Query!
State/province [48]
0
0
Mexico City
Query!
Country [49]
0
0
Panama
Query!
State/province [49]
0
0
Panama City N/A
Query!
Country [50]
0
0
Panama
Query!
State/province [50]
0
0
Panama
Query!
Country [51]
0
0
Portugal
Query!
State/province [51]
0
0
Porto
Query!
Country [52]
0
0
Puerto Rico
Query!
State/province [52]
0
0
San Juan
Query!
Country [53]
0
0
Russian Federation
Query!
State/province [53]
0
0
Moscow N/A
Query!
Country [54]
0
0
Russian Federation
Query!
State/province [54]
0
0
Saint-Petersburg
Query!
Country [55]
0
0
Russian Federation
Query!
State/province [55]
0
0
Smolensk
Query!
Country [56]
0
0
Russian Federation
Query!
State/province [56]
0
0
Voronezh
Query!
Country [57]
0
0
South Africa
Query!
State/province [57]
0
0
Bloemfontein
Query!
Country [58]
0
0
South Africa
Query!
State/province [58]
0
0
Cape Town
Query!
Country [59]
0
0
South Africa
Query!
State/province [59]
0
0
Dundee
Query!
Country [60]
0
0
South Africa
Query!
State/province [60]
0
0
Johannesburg
Query!
Country [61]
0
0
South Africa
Query!
State/province [61]
0
0
Pretoria N/A
Query!
Country [62]
0
0
South Africa
Query!
State/province [62]
0
0
Westdene Johannesburg Gauteng
Query!
Country [63]
0
0
Spain
Query!
State/province [63]
0
0
Barcelona N/A
Query!
Country [64]
0
0
Spain
Query!
State/province [64]
0
0
Barcelona
Query!
Country [65]
0
0
Spain
Query!
State/province [65]
0
0
Elche
Query!
Country [66]
0
0
Spain
Query!
State/province [66]
0
0
Madrid
Query!
Country [67]
0
0
Thailand
Query!
State/province [67]
0
0
Bangkok
Query!
Country [68]
0
0
United Kingdom
Query!
State/province [68]
0
0
London
Query!
Country [69]
0
0
United Kingdom
Query!
State/province [69]
0
0
Manchester
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Tibotec Pharmaceuticals, Ireland
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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 background regimen containing 2 nucleoside/nucleotide reverse
transcriptase inhibitors ( investigator choice of ABC/3TC, TDF/FTC or AZT/3TC) 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 and Medical resource
utilization and treatment adherence.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00543725
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Tibotec Pharmaceuticals, Ireland Clinical Trial
Query!
Address
0
0
Tibotec Pharmaceuticals, Ireland
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00543725
Download to PDF