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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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ClinicalTrials.gov Identifier: NCT00540449
Recruitment Status : Completed
First Posted : October 8, 2007
Results First Posted : July 11, 2011
Last Update Posted : March 29, 2016
Sponsor:
Information provided by (Responsible Party):
Tibotec Pharmaceuticals, Ireland

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions HIV Infections
HIV-1
Human Immunodeficiency Virus Type 1
Interventions Drug: TMC278
Drug: Efavirenz
Enrollment 694
Recruitment Details One hundred and twelve sites in 21 countries randomized participants. In total, 694 participants were randomized: four participants did not start treatment and 690 participants started treatment (346 in the TMC278 group and 344 in the efavirenz [control ] group).
Pre-assignment Details  
Arm/Group Title TMC278 Efavirenz
Hide Arm/Group Description 25 milligram (mg) tablet once daily for 96 weeks. 600 mg once daily for 96 weeks.
Period Title: Overall Study
Started 346 344
Completed 262 266
Not Completed 84 78
Reason Not Completed
Adverse Event             12             32
Sponsor's Decision             1             1
Subject Ineligible To Continue The Trial             2             1
Lost to Follow-up             19             17
Subject Non-Compliant             7             5
Subject Reached A Virologic Endpoint             32             8
Withdrawal by Subject             10             10
Not specified             1             4
Arm/Group Title TMC278 Efavirenz Total
Hide Arm/Group Description 25 milligram (mg) tablet once daily for 96 weeks. 600 mg once daily for 96 weeks. Total of all reporting groups
Overall Number of Baseline Participants 346 344 690
Hide Baseline Analysis Population Description
The analysis population included intent to treat (ITT) population defined as all randomized participants who received at least one dose of the study medication.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 346 participants 344 participants 690 participants
<=18 years
1
   0.3%
0
   0.0%
1
   0.1%
Between 18 and 65 years
343
  99.1%
343
  99.7%
686
  99.4%
>=65 years
2
   0.6%
1
   0.3%
3
   0.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 346 participants 344 participants 690 participants
37  (9.68) 36.7  (9.51) 36.8  (9.59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 346 participants 344 participants 690 participants
Female
78
  22.5%
69
  20.1%
147
  21.3%
Male
268
  77.5%
275
  79.9%
543
  78.7%
Region Enroll  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 346 participants 344 participants 690 participants
Africa 32 31 63
Asia 47 51 98
Latin America 60 69 129
USA, Canada, Europe, Australia 207 193 400
1.Primary Outcome
Title Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies/ml) at Week 48
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set was considered the primary efficacy analysis set.
Arm/Group Title TMC278 Efavirenz
Hide Arm/Group Description:
25 milligram (mg) tablet once daily for 96 weeks.
600 mg once daily for 96 weeks.
Overall Number of Participants Analyzed 346 344
Measure Type: Number
Unit of Measure: Participants
Responder 287 285
Virologic failure 38 15
Discontinued due to Adverse Event (AE) 6 25
Discontinued due to other reason than AE 15 19
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TMC278, Efavirenz
Comments 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.
Type of Statistical Test Non-Inferiority or Equivalence
Comments 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.
Statistical Test of Hypothesis P-Value <0.0001
Comments 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.
Method Regression, Logistic
Comments Logistic regression model included treatment arm as factor and baseline (log10) viral load as covariate.
Method of Estimation Estimation Parameter Difference in proportion of response
Estimated Value -0.4
Confidence Interval 95%
-5.9 to 5.2
Estimation Comments Difference in proportion responders was estimated through the logistic regression model.
2.Secondary Outcome
Title The Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies/ml) at Week 48
Hide 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 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.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set was considered the primary efficacy analysis set.
Arm/Group Title TMC278 Efavirenz
Hide Arm/Group Description:
25 milligram (mg) tablet once daily for 96 weeks.
600 mg once daily for 96 weeks.
Overall Number of Participants Analyzed 346 344
Measure Type: Number
Unit of Measure: Participants
Virologic Response HIV RNA <50 copies/mL at Wk 48 285 281
Virologic Failure 47 24
No Viral Load Data in 48 week window 14 39
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TMC278, Efavirenz
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments 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.
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments Logistic regression model included treatment arm as factor and baseline (log10) viral load as covariate.
Method of Estimation Estimation Parameter Difference in proportion of response
Estimated Value 0.3
Confidence Interval 95%
-5.4 to 5.9
Estimation Comments Difference in proportion responders was estimated through the logistic regression model.
3.Secondary Outcome
Title Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies/ml) at Week 96
Hide Description [Not Specified]
Time Frame Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set was considered the primary efficacy analysis set.
Arm/Group Title TMC278 Efavirenz
Hide Arm/Group Description:
25 milligram (mg) tablet once daily for 96 weeks.
600 mg once daily for 96 weeks.
Overall Number of Participants Analyzed 346 344
Measure Type: Number
Unit of Measure: Participants
Responder 263 271
Virologic failure 45 16
Death 0 3
Discontinued due to AE 10 29
Discontinued due to other reason than AE 28 25
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TMC278, Efavirenz
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments 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.
Statistical Test of Hypothesis P-Value 0.0055
Comments [Not Specified]
Method Regression, Logistic
Comments Logistic regression model included treatment arm as factor and baseline (log10) viral load as covariate.
Method of Estimation Estimation Parameter Difference in proportion of response
Estimated Value -3.2
Confidence Interval 95%
-9.4 to 3.1
Estimation Comments Difference in proportion responders was estimated through the logistic regression model.
4.Secondary Outcome
Title The Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies/ml) at Week 96
Hide Description [Not Specified]
Time Frame Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat analysis set was considered the primary efficacy analysis set.
Arm/Group Title TMC278 Efavirenz
Hide Arm/Group Description:
25 milligram (mg) tablet once daily for 96 weeks.
600 mg once daily for 96 weeks.
Overall Number of Participants Analyzed 346 344
Measure Type: Number
Unit of Measure: Participants
Virologic Response, <50 copies/ml 265 268
Virologic failure 54 27
No viral load data in the 96 week window 27 49
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TMC278, Efavirenz
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments 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.
Statistical Test of Hypothesis P-Value 0.0013
Comments [Not Specified]
Method Regression, Logistic
Comments Logistic regression model included treatment arm as factor and baseline (log10) viral load as covariate.
Method of Estimation Estimation Parameter Difference in proportion of response
Estimated Value -1.7
Confidence Interval 95%
-8.0 to 4.5
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Participants With Virological Response (Observed, <50 Copies/ml) at Last On-Treatment Visit (Post-Week 96).
Hide 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 visit (post-Week 96).
Time Frame Variable, ranging from 3 months up to maximum 15 months for TMC278 and 12 months for Efavirenz after the 96-week visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with at least 1 Post-Week 96 visit were included in the analysis.
Arm/Group Title TMC278 Efavirenz
Hide Arm/Group Description:
25 milligram (mg) tablet once daily for 96 weeks.
600 mg once daily for 96 weeks.
Overall Number of Participants Analyzed 258 271
Measure Type: Number
Unit of Measure: Participants
245 261
6.Secondary Outcome
Title Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies/ml) at Week 48
Hide Description [Not Specified]
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set was considered the primary efficacy analysis set.
Arm/Group Title TMC278 Efavirenz
Hide Arm/Group Description:
25 milligram (mg) tablet once daily for 96 weeks.
600 mg once daily for 96 weeks.
Overall Number of Participants Analyzed 346 344
Measure Type: Number
Unit of Measure: Participants
297 293
7.Secondary Outcome
Title Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies/ml) at Week 96
Hide Description [Not Specified]
Time Frame Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set was considered the primary efficacy analysis set.
Arm/Group Title TMC278 Efavirenz
Hide Arm/Group Description:
25 milligram (mg) tablet once daily for 96 weeks.
600 mg once daily for 96 weeks.
Overall Number of Participants Analyzed 346 344
Measure Type: Number
Unit of Measure: Participants
273 278
8.Secondary Outcome
Title Mean Change From Baseline to Week 48 and Week 96 in Absolute and Relative CD4+ Cell Counts (Using Imputed Data)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set was considered the primary efficacy analysis set.
Arm/Group Title TMC278 Efavirenz
Hide Arm/Group Description:
25 milligram (mg) tablet once daily for 96 weeks.
600 mg once daily for 96 weeks.
Overall Number of Participants Analyzed 346 344
Mean (Standard Deviation)
Unit of Measure: cells per microliter
Absolute cell count, Week 48 195.5  (151.7) 181.6  (156.9)
Absolute cell count, Week 96 220.7  (167.1) 226.7  (188.9)
Relative cell count, Week 48 8.6  (5.8) 8.7  (6.0)
Relative cell count, Week 96 10.1  (7.5) 10.2  (7.2)
9.Secondary Outcome
Title Number of Participants With Virologic Failure for the Resistance Determination by Emerging Resistance Associated Mutations: First Available On-Treatment Genotypic Data After Failure
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT 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 measure.
Arm/Group Title TMC278 Efavirenz
Hide Arm/Group Description:
25 milligram (mg) tablet once daily for 96 weeks.
600 mg once daily for 96 weeks.
Overall Number of Participants Analyzed 52 18
Measure Type: Number
Unit of Measure: Participants
Any RAM from Extended NNRTI RAMs list 29 9
NNRTI RAM: E138K 18 0
NNRTI RAM: K101E 5 0
NNRTI RAM: Y181C 5 0
NNRTI RAM: V90I 4 0
NNRTI RAM: V189I 4 0
NNRTI RAM: H221Y 4 0
NNRTI RAM: E138Q 3 0
NNRTI RAM: K103N 1 8
Any RAM from IAS-USA N(t)RTI RAMs list 31 5
N(t)RTI RAM: M184I 24 3
N(t)RTI RAM: M184V 7 3
N(t)RTI RAM: K065R 3 0
N(t)RTI RAM: K219E 3 0
N(t)RTI RAM: Y115F 2 0
Time Frame Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group.
Adverse Event Reporting Description Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
 
Arm/Group Title TMC278 Efavirenz
Hide Arm/Group Description 25 milligram (mg) tablet once daily for 96 weeks. 600 mg once daily for 96 weeks.
All-Cause Mortality
TMC278 Efavirenz
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
TMC278 Efavirenz
Affected / at Risk (%) Affected / at Risk (%)
Total   40/346 (11.56%)   43/344 (12.50%) 
Blood and lymphatic system disorders     
Febrile neutropenia * 1  0/346 (0.00%)  1/344 (0.29%) 
Agranulocytosis * 1  1/346 (0.29%)  0/344 (0.00%) 
Splenic lesion * 1  1/346 (0.29%)  0/344 (0.00%) 
Cardiac disorders     
Atrial flutter * 1  0/346 (0.00%)  1/344 (0.29%) 
Tachycardia * 1  0/346 (0.00%)  1/344 (0.29%) 
Coronary artery disease * 1  1/346 (0.29%)  0/344 (0.00%) 
Congenital, familial and genetic disorders     
Thyroglossal cyst * 1  0/346 (0.00%)  1/344 (0.29%) 
Pyloric stenosis * 1  1/346 (0.29%)  0/344 (0.00%) 
Gastrointestinal disorders     
Haematemesis * 1  1/346 (0.29%)  0/344 (0.00%) 
Peritoneal haemorrhage * 1  1/346 (0.29%)  0/344 (0.00%) 
Anal inflammation * 1  0/346 (0.00%)  1/344 (0.29%) 
Diarrhoea * 1  0/346 (0.00%)  1/344 (0.29%) 
Gastrointestinal haemorrhage * 1  0/346 (0.00%)  1/344 (0.29%) 
Nausea * 1  0/346 (0.00%)  1/344 (0.29%) 
Vomiting * 1  0/346 (0.00%)  1/344 (0.29%) 
Abdominal pain * 1  1/346 (0.29%)  0/344 (0.00%) 
Anal fissure * 1  1/346 (0.29%)  0/344 (0.00%) 
General disorders     
Chest pain * 1  1/346 (0.29%)  0/344 (0.00%) 
Adverse drug reaction * 1  0/346 (0.00%)  1/344 (0.29%) 
Pelvic mass * 1  0/346 (0.00%)  1/344 (0.29%) 
Pyrexia * 1  0/346 (0.00%)  1/344 (0.29%) 
Hepatobiliary disorders     
Cholecystitis acute * 1  1/346 (0.29%)  0/344 (0.00%) 
Cholelithiasis * 1  1/346 (0.29%)  1/344 (0.29%) 
Cholecystitis * 1  0/346 (0.00%)  1/344 (0.29%) 
Liver disorder * 1  1/346 (0.29%)  0/344 (0.00%) 
Immune system disorders     
Anaphylactic reaction * 1  0/346 (0.00%)  1/344 (0.29%) 
Infections and infestations     
Abscess limb * 1  1/346 (0.29%)  1/344 (0.29%) 
Anogenital warts * 1  1/346 (0.29%)  0/344 (0.00%) 
Appendicitis * 1  1/346 (0.29%)  0/344 (0.00%) 
Bacterial infection * 1  1/346 (0.29%)  0/344 (0.00%) 
Bronchiectasis * 1  1/346 (0.29%)  0/344 (0.00%) 
Cellulitis * 1  2/346 (0.58%)  0/344 (0.00%) 
Diverticulitis * 1  1/346 (0.29%)  0/344 (0.00%) 
Helicobacter gastritis * 1  1/346 (0.29%)  0/344 (0.00%) 
Herpes zoster * 1  1/346 (0.29%)  0/344 (0.00%) 
Lobar pneumonia * 1  1/346 (0.29%)  0/344 (0.00%) 
Neurosyphilis * 1  1/346 (0.29%)  0/344 (0.00%) 
Pneumonia * 1  3/346 (0.87%)  2/344 (0.58%) 
Sepsis * 1  1/346 (0.29%)  0/344 (0.00%) 
Syphilis * 1  1/346 (0.29%)  0/344 (0.00%) 
Arthritis bacterial * 1  0/346 (0.00%)  1/344 (0.29%) 
Bronchitis * 1  0/346 (0.00%)  1/344 (0.29%) 
Cerebral toxoplasmosis * 1  0/346 (0.00%)  1/344 (0.29%) 
Gastroenteritis * 1  0/346 (0.00%)  1/344 (0.29%) 
Streptococcal bacteraemia * 1  0/346 (0.00%)  1/344 (0.29%) 
Tuberculous pleurisy * 1  0/346 (0.00%)  1/344 (0.29%) 
Upper respiratory tract infection * 1  0/346 (0.00%)  1/344 (0.29%) 
Bone tuberculosis * 1  1/346 (0.29%)  0/344 (0.00%) 
Folliculitis * 1  0/346 (0.00%)  1/344 (0.29%) 
Meningococcal sepsis * 1  0/346 (0.00%)  1/344 (0.29%) 
Mycobacterium avium complex infection * 1  1/346 (0.29%)  0/344 (0.00%) 
Osteomyelitis * 1  1/346 (0.29%)  0/344 (0.00%) 
Papilloma viral infection * 1  0/346 (0.00%)  1/344 (0.29%) 
Respiratory tract infection * 1  0/346 (0.00%)  1/344 (0.29%) 
Tuberculosis * 1  1/346 (0.29%)  0/344 (0.00%) 
Injury, poisoning and procedural complications     
Alcohol poisoning * 1  1/346 (0.29%)  0/344 (0.00%) 
Overdose * 1  1/346 (0.29%)  0/344 (0.00%) 
Drug toxicity * 1  0/346 (0.00%)  1/344 (0.29%) 
Ankle fracture * 1  1/346 (0.29%)  0/344 (0.00%) 
Concussion * 1  0/346 (0.00%)  1/344 (0.29%) 
Facial bones fracture * 1  0/346 (0.00%)  1/344 (0.29%) 
Injury * 1  1/346 (0.29%)  0/344 (0.00%) 
Jaw fracture * 1  0/346 (0.00%)  1/344 (0.29%) 
Poisoning * 1  1/346 (0.29%)  0/344 (0.00%) 
Sternal fracture * 1  1/346 (0.29%)  0/344 (0.00%) 
Investigations     
Alanine aminotransferase increased * 1  0/346 (0.00%)  2/344 (0.58%) 
Aspartate aminotransferase increased * 1  0/346 (0.00%)  1/344 (0.29%) 
Blood alkaline phosphatase increased * 1  0/346 (0.00%)  1/344 (0.29%) 
Transaminases increased * 1  0/346 (0.00%)  1/344 (0.29%) 
Metabolism and nutrition disorders     
Anorexia * 1  0/346 (0.00%)  1/344 (0.29%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/346 (0.29%)  0/344 (0.00%) 
Joint swelling * 1  1/346 (0.29%)  0/344 (0.00%) 
Spondylitis * 1  1/346 (0.29%)  0/344 (0.00%) 
Back pain * 1  0/346 (0.00%)  1/344 (0.29%) 
Intervertebral disc protrusion * 1  0/346 (0.00%)  1/344 (0.29%) 
Spinal osteoarthritis * 1  1/346 (0.29%)  0/344 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder cancer * 1  1/346 (0.29%)  0/344 (0.00%) 
Haemangioma * 1  1/346 (0.29%)  0/344 (0.00%) 
Kaposi's sarcoma * 1  1/346 (0.29%)  0/344 (0.00%) 
Uterine leiomyoma * 1  1/346 (0.29%)  1/344 (0.29%) 
Anal cancer stage 0 * 1  0/346 (0.00%)  1/344 (0.29%) 
Burkitt's lymphoma * 1  2/346 (0.58%)  2/344 (0.58%) 
Anal cancer * 1  0/346 (0.00%)  1/344 (0.29%) 
Hepatic neoplasm * 1  0/346 (0.00%)  1/344 (0.29%) 
Hepatic neoplasm malignant * 1  0/346 (0.00%)  1/344 (0.29%) 
Nervous system disorders     
Miller fisher syndrome * 1  1/346 (0.29%)  0/344 (0.00%) 
Cerebral ischaemia * 1  0/346 (0.00%)  1/344 (0.29%) 
Cerebrovascular accident * 1  0/346 (0.00%)  1/344 (0.29%) 
Coma * 1  0/346 (0.00%)  1/344 (0.29%) 
Headache * 1  1/346 (0.29%)  1/344 (0.29%) 
Sciatica * 1  0/346 (0.00%)  1/344 (0.29%) 
Psychiatric disorders     
Alcoholism * 1  1/346 (0.29%)  0/344 (0.00%) 
Depression * 1  2/346 (0.58%)  2/344 (0.58%) 
Drug dependence * 1  1/346 (0.29%)  0/344 (0.00%) 
Major depression * 1  1/346 (0.29%)  0/344 (0.00%) 
Suicide attempt * 1  1/346 (0.29%)  0/344 (0.00%) 
Bipolar disorder * 1  0/346 (0.00%)  1/344 (0.29%) 
Homicidal ideation * 1  1/346 (0.29%)  1/344 (0.29%) 
Acute psychosis * 1  1/346 (0.29%)  0/344 (0.00%) 
Panic attack * 1  0/346 (0.00%)  1/344 (0.29%) 
Psychotic disorder * 1  0/346 (0.00%)  2/344 (0.58%) 
Suicidal ideation * 1  3/346 (0.87%)  1/344 (0.29%) 
Renal and urinary disorders     
Calculus ureteric * 1  1/346 (0.29%)  0/344 (0.00%) 
Glomerulonephritis membranous * 1  1/346 (0.29%)  0/344 (0.00%) 
Reproductive system and breast disorders     
Cystocele * 1  1/346 (0.29%)  0/344 (0.00%) 
Uterovaginal prolapse * 1  1/346 (0.29%)  0/344 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma * 1  1/346 (0.29%)  0/344 (0.00%) 
Dyspnoea * 1  0/346 (0.00%)  1/344 (0.29%) 
Pneumothorax * 1  1/346 (0.29%)  1/344 (0.29%) 
Pulmonary embolism * 1  0/346 (0.00%)  1/344 (0.29%) 
Asphyxia * 1  0/346 (0.00%)  1/344 (0.29%) 
Skin and subcutaneous tissue disorders     
Erythema * 1  1/346 (0.29%)  0/344 (0.00%) 
Rash generalised * 1  0/346 (0.00%)  1/344 (0.29%) 
Surgical and medical procedures     
Bowel preparation * 1  0/346 (0.00%)  1/344 (0.29%) 
Drug rehabilitation * 1  0/346 (0.00%)  1/344 (0.29%) 
Vascular disorders     
Circulatory collapse * 1  1/346 (0.29%)  0/344 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TMC278 Efavirenz
Affected / at Risk (%) Affected / at Risk (%)
Total   231/346 (66.76%)   268/344 (77.91%) 
Gastrointestinal disorders     
Nausea * 1  44/346 (12.72%)  38/344 (11.05%) 
Diarrhoea * 1  51/346 (14.74%)  61/344 (17.73%) 
Vomiting * 1  15/346 (4.34%)  21/344 (6.10%) 
General disorders     
Fatigue * 1  20/346 (5.78%)  31/344 (9.01%) 
Infections and infestations     
Upper respiratory tract infection * 1  53/346 (15.32%)  51/344 (14.83%) 
Nasopharyngitis * 1  45/346 (13.01%)  44/344 (12.79%) 
Influenza * 1  37/346 (10.69%)  34/344 (9.88%) 
Syphilis * 1  22/346 (6.36%)  15/344 (4.36%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  15/346 (4.34%)  20/344 (5.81%) 
Back pain * 1  23/346 (6.65%)  24/344 (6.98%) 
Nervous system disorders     
Headache * 1  50/346 (14.45%)  44/344 (12.79%) 
Dizziness * 1  28/346 (8.09%)  91/344 (26.45%) 
Somnolence * 1  14/346 (4.05%)  24/344 (6.98%) 
Psychiatric disorders     
Abnormal dreams * 1  29/346 (8.38%)  41/344 (11.92%) 
Insomnia * 1  36/346 (10.40%)  39/344 (11.34%) 
Depression * 1  25/346 (7.23%)  21/344 (6.10%) 
Anxiety * 1  9/346 (2.60%)  27/344 (7.85%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  23/346 (6.65%)  20/344 (5.81%) 
Skin and subcutaneous tissue disorders     
Rash * 1  26/346 (7.51%)  42/344 (12.21%) 
Pruritus * 1  8/346 (2.31%)  18/344 (5.23%) 
Vascular disorders     
Hypertension * 1  21/346 (6.07%)  18/344 (5.23%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
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.
 
Results Point of Contact
Name/Title: Medical Leader
Organization: Janssen Infectious Diseases BVBA
Responsible Party: Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier: NCT00540449     History of Changes
Obsolete Identifiers: NCT00613639
Other Study ID Numbers: CR002689
TMC278-TIDP6-C209 ( Other Identifier: Tibotec Pharmaceuticals, Ireland )
First Submitted: October 4, 2007
First Posted: October 8, 2007
Results First Submitted: June 14, 2011
Results First Posted: July 11, 2011
Last Update Posted: March 29, 2016