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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier:
NCT00543725
First received: October 11, 2007
Last updated: March 3, 2016
Last verified: March 2016
Results First Received: June 14, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV Infections
HIV-1
Interventions: Drug: TMC278
Drug: efavirenz

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A phase III, randomized, double-blind trial of TMC278 25 mg q.d. versus efavirenz 600mg q.d. in combination with a background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors in antiretroviral-naïve HIV-1 infected subjects

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
680 participants were randomized (340 in TMC 278 and 340 in efavirenz) but only 338 participants were treated with efavirenz (2 were randomized but not treated).

Reporting Groups
  Description
TMC278 25 mg tablet once daily
Efavirenz 600 mg once daily

Participant Flow:   Overall Study
    TMC278     Efavirenz  
STARTED     340     338  
COMPLETED     272     264  
NOT COMPLETED     68     74  
Adverse Event                 18                 27  
Sponsor's Decision                 0                 1  
Subject Non-Compliant                 4                 4  
Subject Ineligible To Continue The Trial                 2                 0  
Subject Reached A Virologic Endpoint                 22                 14  
Protocol Violation                 0                 1  
Withdrawal by Subject                 4                 13  
Lost to Follow-up                 15                 11  
Not specified                 3                 3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
TMC278 25 mg tablet once daily
Efavirenz 600 mg once daily
Total Total of all reporting groups

Baseline Measures
    TMC278     Efavirenz     Total  
Number of Participants  
[units: participants]
  340     338     678  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     339     337     676  
>=65 years     1     1     2  
Age  
[units: years]
Mean (Standard Deviation)
  36.7  (9.39)     36.4  (8.92)     36.5  (9.15)  
Gender  
[units: participants]
     
Female     90     94     184  
Male     250     244     494  
Region Enroll  
[units: participants]
     
Africa     19     38     57  
Asia     59     61     120  
Latin America     90     85     175  
USA, Canada, Europe, Australia     172     154     326  



  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 48   [ Time Frame: Week 48 ]

Measure Type Primary
Measure Title Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 48
Measure Description 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).
Time Frame Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Intent-to-Treat analysis set was considered the primary efficacy analysis set.

Reporting Groups
  Description
TMC278 25 mg tablet once daily
Efavirenz 600 mg once daily

Measured Values
    TMC278     Efavirenz  
Number of Participants Analyzed  
[units: participants]
  340     338  
Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 48  
[units: Participants]
   
Responder     291     276  
Virologic failure     24     18  
Death     1     3  
Discontinued due to AE     8     21  
Discontinued due to other reason than AE     16     20  


Statistical Analysis 1 for Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 48
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Regression, Logistic
P Value [4] <0.0001
Difference in proportion of response [5] 3.7
95% Confidence Interval -1.6 to 9.0
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Assuming a response rate of 75% at 48 weeks for both treatment groups, 340 subjects were needed per treatment (TMC278 or EFV) to establish non-inferiority of TMC278 versus EFV with a maximum allowable difference of 12% and a 1-sided significance level of 2.5%, to yield 95% power.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 – EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Logistic regression model included treatment arm and background NRTI regimen as factors, and baseline (log10) viral load as covariate.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Significance level was set at 2.5% (one-sided). No adjustment of p-value for multiple comparisons, since there was only single comparison for the primary endpoint.
[5] Other relevant estimation information:
  Difference in proportion responders was estimated through the logistic regression model.



2.  Secondary:   Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies Per mL) at Week 48   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies Per mL) at Week 48
Measure Description 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.
Time Frame Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Intent-to-Treat analysis set was considered the primary efficacy analysis set.

Reporting Groups
  Description
TMC278 25 mg tablet once daily
Efavirenz 600 mg once daily

Measured Values
    TMC278     Efavirenz  
Number of Participants Analyzed  
[units: participants]
  340     338  
Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies Per mL) at Week 48  
[units: Participants]
   
Virologic Response (<50 copies/mL)     281     265  
Virologic failure     41     38  
No plasma viral load data in 48-week window     18     35  


Statistical Analysis 1 for Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies Per mL) at Week 48
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Regression, Logistic
P Value [4] <0.0001
Difference in proportion of response [5] 3.9
95% Confidence Interval -1.9 to 9.6
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 – EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Logistic regression model included treatment arm and background NRTI regimen as factors, and baseline (log10) viral load as covariate.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  Difference in proportion responders was estimated through the logistic regression model.



3.  Secondary:   Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 96   [ Time Frame: Week 96 ]

Measure Type Secondary
Measure Title Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 96
Measure Description No text entered.
Time Frame Week 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Intent-to-Treat analysis set was considered the primary efficacy analysis set.

Reporting Groups
  Description
TMC278 25 mg tablet once daily
Efavirenz 600 mg once daily

Measured Values
    TMC278     Efavirenz  
Number of Participants Analyzed  
[units: participants]
  340     338  
Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 96  
[units: Participants]
   
Responder     269     258  
Virologic failure     34     24  
Death     1     3  
Discontinued due to AE     16     23  
Discontinued due to other reason than AE     20     30  


Statistical Analysis 1 for Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 96
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Regression, Logistic
P Value [4] <0.0001
Difference in proportion of response [5] 2.4
95% Confidence Interval -3.6 to 8.4
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Assuming a response rate of 75% at 48 weeks for both treatment groups, 340 subjects were needed per treatment (TMC278 or EFV) to establish non-inferiority of TMC278 versus EFV with a maximum allowable difference of 12% and a 1-sided significance level of 2.5%, to yield 95% power.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 – EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Logistic regression model included treatment arm and background NRTI regimen as factors, and baseline (log10) viral load as covariate.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Significance level was set at 2.5% (one-sided). No adjustment of p-value for multiple comparisons, since there was only single comparison for the primary endpoint.
[5] Other relevant estimation information:
  Difference in proportion responders was estimated through the logistic regression model.



4.  Secondary:   Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies Per mL) at Week 96   [ Time Frame: Week 96 ]

Measure Type Secondary
Measure Title Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies Per mL) at Week 96
Measure Description No text entered.
Time Frame Week 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Intent-to-Treat analysis set was considered the primary efficacy analysis set.

Reporting Groups
  Description
TMC278 25 mg tablet once daily
Efavirenz 600 mg once daily

Measured Values
    TMC278     Efavirenz  
Number of Participants Analyzed  
[units: participants]
  340     338  
Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies Per mL) at Week 96  
[units: Participants]
   
Virologic response (<50 copies/mL)     259     254  
Virologic failure     53     38  
No plasma viral load data in 96-Week window     28     46  


Statistical Analysis 1 for Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies Per mL) at Week 96
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Regression, Logistic
P Value [4] <0.0001
Difference in proportion of response [5] 0.7
95% Confidence Interval -5.6 to 7.0
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 – EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Logistic regression model included treatment arm and background NRTI regimen as factors, and baseline (log10) viral load as covariate.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  Difference in proportion responders was estimated through the logistic regression model.



5.  Secondary:   Number of Participants With Virological Response (Observed, <50 Copies/mL) at Last On-Treatment Visit (Post-Week 96).   [ Time Frame: Variable, ranging from 3 months up to maximum 18 months for TMC278 and 12 months for Efavirenz ]

Measure Type Secondary
Measure Title Number of Participants With Virological Response (Observed, <50 Copies/mL) at Last On-Treatment Visit (Post-Week 96).
Measure Description 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.
Time Frame Variable, ranging from 3 months up to maximum 18 months for TMC278 and 12 months for Efavirenz  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants with at least 1 Post-Week 96 visit were included in the analysis.

Reporting Groups
  Description
TMC278 25 mg tablet once daily
Efavirenz 600 mg once daily

Measured Values
    TMC278     Efavirenz  
Number of Participants Analyzed  
[units: participants]
  269     257  
Number of Participants With Virological Response (Observed, <50 Copies/mL) at Last On-Treatment Visit (Post-Week 96).  
[units: Participants]
  260     246  

No statistical analysis provided for Number of Participants With Virological Response (Observed, <50 Copies/mL) at Last On-Treatment Visit (Post-Week 96).



6.  Secondary:   Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies Per mL) at Week 48   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies Per mL) at Week 48
Measure Description 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).
Time Frame Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Intent-to-Treat analysis set was considered the primary efficacy analysis set.

Reporting Groups
  Description
TMC278 25 mg tablet once daily
Efavirenz 600 mg once daily

Measured Values
    TMC278     Efavirenz  
Number of Participants Analyzed  
[units: participants]
  340     338  
Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies Per mL) at Week 48  
[units: Participants]
  300     286  

No statistical analysis provided for Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies Per mL) at Week 48



7.  Secondary:   Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies Per mL) at Week 96   [ Time Frame: Week 96 ]

Measure Type Secondary
Measure Title Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies Per mL) at Week 96
Measure Description 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).
Time Frame Week 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Intent-to-Treat analysis set was considered the primary efficacy analysis set.

Reporting Groups
  Description
TMC278 25 mg tablet once daily
Efavirenz 600 mg once daily

Measured Values
    TMC278     Efavirenz  
Number of Participants Analyzed  
[units: participants]
  340     338  
Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies Per mL) at Week 96  
[units: Participants]
  283     270  

No statistical analysis provided for Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies Per mL) at Week 96



8.  Secondary:   Mean Change From Baseline to Week 48 and Week 96 in Absolute and Relative CD4+ Cell Counts (Using Imputed Data)   [ Time Frame: Baseline, Week 48, and Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline to Week 48 and Week 96 in Absolute and Relative CD4+ Cell Counts (Using Imputed Data)
Measure Description 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.
Time Frame Baseline, Week 48, and Week 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Intent-to-Treat analysis set was considered the primary efficacy analysis set.

Reporting Groups
  Description
TMC278 25 mg tablet once daily
Efavirenz 600 mg once daily

Measured Values
    TMC278     Efavirenz  
Number of Participants Analyzed  
[units: participants]
  339     338  
Mean Change From Baseline to Week 48 and Week 96 in Absolute and Relative CD4+ Cell Counts (Using Imputed Data)  
[units: cells per microliter]
Mean (95% Confidence Interval)
   
Absolute cell count, Week 48     188.6  
  (173.98 to 203.15)  
  170.7  
  (154.55 to 186.77)  
Absolute cell count, Week 96     234.5  
  (217.40 to 251.55)  
  212.0  
  (193.70 to 230.34)  
Relative cell count, Week 48     8.3  
  (7.68 to 8.85)  
  8.0  
  (7.39 to 8.60)  
Relative cell count, Week 96     10.1  
  (9.35 to 10.75)  
  9.7  
  (8.95 to 10.40)  

No statistical analysis provided for Mean Change From Baseline to Week 48 and Week 96 in Absolute and Relative CD4+ Cell Counts (Using Imputed Data)



9.  Secondary:   Number of Participants With Virologic Failure for the Resistance Determinations by Developing Mutations: First Available On-Treatment Genotypic Data After Failure   [ Time Frame: Week 96 ]

Measure Type Secondary
Measure Title Number of Participants With Virologic Failure for the Resistance Determinations by Developing Mutations: First Available On-Treatment Genotypic Data After Failure
Measure Description 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).
Time Frame Week 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Intent-to-Treat analysis set was considered the primary efficacy analysis set. Here "N" (Number of Participants Analyzed) signifies number of Participants who were evaluable (had data) for this outcome.

Reporting Groups
  Description
TMC278 25 mg tablet once daily
Efavirenz 600 mg once daily

Measured Values
    TMC278     Efavirenz  
Number of Participants Analyzed  
[units: participants]
  34     24  
Number of Participants With Virologic Failure for the Resistance Determinations by Developing Mutations: First Available On-Treatment Genotypic Data After Failure  
[units: Participants]
   
Treatment-emergent NNRTI RAM     17     11  
E138K     13     1  
H221Y     3     0  
K101E     3     2  
K103N     0     6  
V90I     2     1  
V106M     0     2  
V189I     2     0  
Y188C     0     2  
Treatment-emergent N(t)RTI RAM     17     6  
K65R     0     2  
K219E     2     0  
M184I     8     1  
M184V     10     3  

No statistical analysis provided for Number of Participants With Virologic Failure for the Resistance Determinations by Developing Mutations: First Available On-Treatment Genotypic Data After Failure




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Medical Leader
Organization: Janssen Infectious Diseases BVBA
phone: 32 14 641418


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier: NCT00543725     History of Changes
Obsolete Identifiers: NCT00614692
Other Study ID Numbers: CR002704
TMC278-TIDP6-C215 ( Other Identifier: Tibotec Pharmaceuticals, Ireland )
Study First Received: October 11, 2007
Results First Received: June 14, 2011
Last Updated: March 3, 2016
Health Authority: United States: Food and Drug Administration
Ireland: Irish Agriculture and Food Development Authority
Canada: Health Canada
China: Food and Drug Administration
Great Britain: Medicines and Healthcare Products Regulatory Agency
United States: Federal Government
Great Britain: Research Ethics Committee