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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

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ClinicalTrials.gov Identifier: NCT00543725
Recruitment Status : Completed
First Posted : October 15, 2007
Results First Posted : July 12, 2011
Last Update Posted : April 1, 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
Interventions Drug: TMC278
Drug: efavirenz
Enrollment 680
Recruitment Details 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 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).
Arm/Group Title TMC278 Efavirenz
Hide Arm/Group Description 25 mg tablet once daily 600 mg once daily
Period Title: Overall Study
Started 340 338
Completed 272 264
Not Completed 68 74
Reason Not Completed
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
Other             3             3
Arm/Group Title TMC278 Efavirenz Total
Hide Arm/Group Description 25 mg tablet once daily 600 mg once daily Total of all reporting groups
Overall Number of Baseline Participants 340 338 678
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 340 participants 338 participants 678 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
339
  99.7%
337
  99.7%
676
  99.7%
>=65 years
1
   0.3%
1
   0.3%
2
   0.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 340 participants 338 participants 678 participants
36.7  (9.39) 36.4  (8.92) 36.5  (9.15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 340 participants 338 participants 678 participants
Female
90
  26.5%
94
  27.8%
184
  27.1%
Male
250
  73.5%
244
  72.2%
494
  72.9%
Region Enroll  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 340 participants 338 participants 678 participants
Africa 19 38 57
Asia 59 61 120
Latin America 90 85 175
USA, Canada, Europe, Australia 172 154 326
1.Primary Outcome
Title Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per 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
Hide 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 mg tablet once daily
600 mg once daily
Overall Number of Participants Analyzed 340 338
Measure Type: Number
Unit of Measure: 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
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 and background NRTI regimen as factors, and baseline (log10) viral load as covariate.
Method of Estimation Estimation Parameter Difference in proportion of response
Estimated Value 3.7
Confidence Interval 95%
-1.6 to 9.0
Estimation Comments Difference in proportion responders was estimated through the logistic regression model.
2.Secondary Outcome
Title Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies Per 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 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
Hide 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 mg tablet once daily
600 mg once daily
Overall Number of Participants Analyzed 340 338
Measure Type: Number
Unit of Measure: Participants
Virologic Response (<50 copies/mL) 281 265
Virologic failure 41 38
No plasma viral load data in 48-week window 18 35
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 and background NRTI regimen as factors, and baseline (log10) viral load as covariate.
Method of Estimation Estimation Parameter Difference in proportion of response
Estimated Value 3.9
Confidence Interval 95%
-1.9 to 9.6
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 Per mL) at Week 96
Hide Description [Not Specified]
Time Frame Week 96
Hide 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 mg tablet once daily
600 mg once daily
Overall Number of Participants Analyzed 340 338
Measure Type: Number
Unit of Measure: 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
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 and background NRTI regimen as factors, and baseline (log10) viral load as covariate.
Method of Estimation Estimation Parameter Difference in proportion of response
Estimated Value 2.4
Confidence Interval 95%
-3.6 to 8.4
Estimation Comments Difference in proportion responders was estimated through the logistic regression model.
4.Secondary Outcome
Title Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies Per mL) at Week 96
Hide Description [Not Specified]
Time Frame Week 96
Hide 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 mg tablet once daily
600 mg once daily
Overall Number of Participants Analyzed 340 338
Measure Type: Number
Unit of Measure: Participants
Virologic response (<50 copies/mL) 259 254
Virologic failure 53 38
No plasma viral load data in 96-Week window 28 46
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 and background NRTI regimen as factors, and baseline (log10) viral load as covariate.
Method of Estimation Estimation Parameter Difference in proportion of response
Estimated Value 0.7
Confidence Interval 95%
-5.6 to 7.0
Estimation Comments Difference in proportion responders was estimated through the logistic regression model.
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 post-Week 96 visit.
Time Frame Variable, ranging from 3 months up to maximum 18 months for TMC278 and 12 months for Efavirenz
Hide 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 mg tablet once daily
600 mg once daily
Overall Number of Participants Analyzed 269 257
Measure Type: Number
Unit of Measure: Participants
260 246
6.Secondary Outcome
Title Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies Per mL) at Week 48
Hide 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
Hide 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 mg tablet once daily
600 mg once daily
Overall Number of Participants Analyzed 340 338
Measure Type: Number
Unit of Measure: Participants
300 286
7.Secondary Outcome
Title Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies Per mL) at Week 96
Hide 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
Hide 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 mg tablet once daily
600 mg once daily
Overall Number of Participants Analyzed 340 338
Measure Type: Number
Unit of Measure: Participants
283 270
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
Hide 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 mg tablet once daily
600 mg once daily
Overall Number of Participants Analyzed 339 338
Mean (95% Confidence Interval)
Unit of Measure: cells per microliter
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)
9.Secondary Outcome
Title Number of Participants With Virologic Failure for the Resistance Determinations by Developing 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title TMC278 Efavirenz
Hide Arm/Group Description:
25 mg tablet once daily
600 mg once daily
Overall Number of Participants Analyzed 34 24
Measure Type: Number
Unit of Measure: 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
Time Frame Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group.
Adverse Event Reporting Description Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.
 
Arm/Group Title TMC278 Efavirenz
Hide Arm/Group Description 25 mg tablet once daily 600 mg once daily
All-Cause Mortality
TMC278 Efavirenz
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
TMC278 Efavirenz
Affected / at Risk (%) Affected / at Risk (%)
Total   32/340 (9.41%)   31/338 (9.17%) 
Blood and lymphatic system disorders     
Anaemia * 1  1/340 (0.29%)  1/338 (0.30%) 
Thrombocytopenia * 1  1/340 (0.29%)  0/338 (0.00%) 
Pancytopenia * 1  0/340 (0.00%)  1/338 (0.30%) 
Neutropenia * 1  1/340 (0.29%)  0/338 (0.00%) 
Cardiac disorders     
Arteriospasm coronary * 1  1/340 (0.29%)  0/338 (0.00%) 
Atrial fibrillation * 1  1/340 (0.29%)  0/338 (0.00%) 
Eye disorders     
Macular hole * 1  0/340 (0.00%)  1/338 (0.30%) 
Gastrointestinal disorders     
Diarrhoea * 1  1/340 (0.29%)  0/338 (0.00%) 
Inguinal hernia * 1  1/340 (0.29%)  0/338 (0.00%) 
Intestinal obstruction * 1  1/340 (0.29%)  0/338 (0.00%) 
Jejunitis * 1  1/340 (0.29%)  0/338 (0.00%) 
Vomiting * 1  1/340 (0.29%)  1/338 (0.30%) 
Abdominal pain * 1  0/340 (0.00%)  1/338 (0.30%) 
Pancreatitis * 1  0/340 (0.00%)  1/338 (0.30%) 
General disorders     
Asthenia * 1  1/340 (0.29%)  0/338 (0.00%) 
Non-cardiac chest pain * 1  2/340 (0.59%)  2/338 (0.59%) 
Pyrexia * 1  1/340 (0.29%)  0/338 (0.00%) 
Hepatobiliary disorders     
Cholecystitis acute * 1  2/340 (0.59%)  0/338 (0.00%) 
Cholelithiasis * 1  1/340 (0.29%)  1/338 (0.30%) 
Hyperbilirubinaemia * 1  1/340 (0.29%)  0/338 (0.00%) 
Hepatotoxicity * 1  1/340 (0.29%)  0/338 (0.00%) 
Immune system disorders     
Allergy to arthropod sting * 1  1/340 (0.29%)  0/338 (0.00%) 
Drug hypersensitivity * 1  1/340 (0.29%)  0/338 (0.00%) 
Food allergy * 1  0/340 (0.00%)  1/338 (0.30%) 
Infections and infestations     
Pneumonia * 1  2/340 (0.59%)  1/338 (0.30%) 
Bronchitis * 1  1/340 (0.29%)  0/338 (0.00%) 
Bronchopneumonia * 1  2/340 (0.59%)  0/338 (0.00%) 
Furuncle * 1  1/340 (0.29%)  0/338 (0.00%) 
Gastroenteritis viral * 1  1/340 (0.29%)  0/338 (0.00%) 
Helicobacter gastritis * 1  1/340 (0.29%)  0/338 (0.00%) 
Pulmonary tuberculosis * 1  2/340 (0.59%)  0/338 (0.00%) 
Cerebral toxoplasmosis * 1  0/340 (0.00%)  1/338 (0.30%) 
Cyclosporidium infection * 1  0/340 (0.00%)  1/338 (0.30%) 
Dysentery * 1  0/340 (0.00%)  1/338 (0.30%) 
Encephalitis herpes * 1  0/340 (0.00%)  1/338 (0.30%) 
Hepatitis c * 1  0/340 (0.00%)  1/338 (0.30%) 
Herpes zoster * 1  1/340 (0.29%)  1/338 (0.30%) 
Meningitis bacterial * 1  0/340 (0.00%)  1/338 (0.30%) 
Pelvic inflammatory disease * 1  0/340 (0.00%)  1/338 (0.30%) 
Respiratory tract infection * 1  0/340 (0.00%)  1/338 (0.30%) 
Staphylococcal infection * 1  0/340 (0.00%)  1/338 (0.30%) 
Arthritis gonococcal * 1  0/340 (0.00%)  1/338 (0.30%) 
Bacterial sepsis * 1  1/340 (0.29%)  0/338 (0.00%) 
Cellulitis * 1  0/340 (0.00%)  1/338 (0.30%) 
Diarrhoea infectious * 1  1/340 (0.29%)  0/338 (0.00%) 
External ear cellulitis * 1  1/340 (0.29%)  0/338 (0.00%) 
Gastroenteritis shigella * 1  1/340 (0.29%)  0/338 (0.00%) 
Hepatitis b * 1  1/340 (0.29%)  0/338 (0.00%) 
Secondary syphilis * 1  1/340 (0.29%)  0/338 (0.00%) 
Injury, poisoning and procedural complications     
Clavicle fracture * 1  1/340 (0.29%)  0/338 (0.00%) 
Fall * 1  1/340 (0.29%)  0/338 (0.00%) 
Humerus fracture * 1  1/340 (0.29%)  0/338 (0.00%) 
Pelvic fracture * 1  1/340 (0.29%)  0/338 (0.00%) 
Brain contusion * 1  0/340 (0.00%)  1/338 (0.30%) 
Lumbar vertebral fracture * 1  0/340 (0.00%)  1/338 (0.30%) 
Radius fracture * 1  0/340 (0.00%)  1/338 (0.30%) 
Joint sprain * 1  1/340 (0.29%)  0/338 (0.00%) 
Investigations     
Brain scan abnormal * 1  1/340 (0.29%)  0/338 (0.00%) 
Blood amylase increased * 1  0/340 (0.00%)  1/338 (0.30%) 
Lipase increased * 1  0/340 (0.00%)  1/338 (0.30%) 
Metabolism and nutrition disorders     
Dehydration * 1  1/340 (0.29%)  0/338 (0.00%) 
Musculoskeletal and connective tissue disorders     
Foot deformity * 1  1/340 (0.29%)  0/338 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Uterine leiomyoma * 1  0/340 (0.00%)  2/338 (0.59%) 
Hodgkin's disease * 1  1/340 (0.29%)  0/338 (0.00%) 
Nervous system disorders     
Cerebellar infarction * 1  1/340 (0.29%)  0/338 (0.00%) 
Convulsion * 1  1/340 (0.29%)  0/338 (0.00%) 
Dizziness * 1  1/340 (0.29%)  0/338 (0.00%) 
Cerebrovascular accident * 1  0/340 (0.00%)  1/338 (0.30%) 
Grand mal convulsion * 1  0/340 (0.00%)  1/338 (0.30%) 
Haemorrhage intracranial * 1  0/340 (0.00%)  1/338 (0.30%) 
Psychiatric disorders     
Depression * 1  2/340 (0.59%)  0/338 (0.00%) 
Suicide attempt * 1  1/340 (0.29%)  0/338 (0.00%) 
Acute psychosis * 1  0/340 (0.00%)  1/338 (0.30%) 
Alcohol withdrawal syndrome * 1  0/340 (0.00%)  1/338 (0.30%) 
Psychotic disorder due to a general medical condition * 1  0/340 (0.00%)  1/338 (0.30%) 
Renal and urinary disorders     
Renal failure acute * 1  1/340 (0.29%)  1/338 (0.30%) 
Acute prerenal failure * 1  1/340 (0.29%)  0/338 (0.00%) 
Reproductive system and breast disorders     
Ovarian cyst * 1  0/340 (0.00%)  1/338 (0.30%) 
Respiratory, thoracic and mediastinal disorders     
Pneumothorax * 1  1/340 (0.29%)  0/338 (0.00%) 
Asthma * 1  0/340 (0.00%)  1/338 (0.30%) 
Respiratory failure * 1  0/340 (0.00%)  1/338 (0.30%) 
Skin and subcutaneous tissue disorders     
Pruritus generalised * 1  1/340 (0.29%)  0/338 (0.00%) 
Palmar-plantar erythrodysaesthesia syndrome * 1  0/340 (0.00%)  1/338 (0.30%) 
Rash * 1  0/340 (0.00%)  1/338 (0.30%) 
Dermal cyst * 1  1/340 (0.29%)  0/338 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TMC278 Efavirenz
Affected / at Risk (%) Affected / at Risk (%)
Total   253/340 (74.41%)   259/338 (76.63%) 
Gastrointestinal disorders     
Nausea * 1  57/340 (16.76%)  67/338 (19.82%) 
Diarrhoea * 1  49/340 (14.41%)  53/338 (15.68%) 
Vomiting * 1  22/340 (6.47%)  26/338 (7.69%) 
General disorders     
Fatigue * 1  20/340 (5.88%)  29/338 (8.58%) 
Pyrexia * 1  15/340 (4.41%)  17/338 (5.03%) 
Infections and infestations     
Nasopharyngitis * 1  50/340 (14.71%)  47/338 (13.91%) 
Upper respiratory tract infection * 1  43/340 (12.65%)  37/338 (10.95%) 
Bronchitis * 1  31/340 (9.12%)  6/338 (1.78%) 
Influenza * 1  32/340 (9.41%)  30/338 (8.88%) 
Pharyngitis * 1  20/340 (5.88%)  14/338 (4.14%) 
Anogenital warts * 1  17/340 (5.00%)  14/338 (4.14%) 
Sinusitis * 1  17/340 (5.00%)  19/338 (5.62%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  16/340 (4.71%)  30/338 (8.88%) 
Arthralgia * 1  10/340 (2.94%)  17/338 (5.03%) 
Nervous system disorders     
Headache * 1  61/340 (17.94%)  53/338 (15.68%) 
Dizziness * 1  42/340 (12.35%)  111/338 (32.84%) 
Somnolence * 1  17/340 (5.00%)  28/338 (8.28%) 
Psychiatric disorders     
Insomnia * 1  38/340 (11.18%)  21/338 (6.21%) 
Abnormal dreams * 1  19/340 (5.59%)  26/338 (7.69%) 
Depression * 1  24/340 (7.06%)  19/338 (5.62%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  33/340 (9.71%)  15/338 (4.44%) 
Pharyngolaryngeal pain * 1  19/340 (5.59%)  6/338 (1.78%) 
Skin and subcutaneous tissue disorders     
Rash * 1  15/340 (4.41%)  49/338 (14.50%) 
Pruritus * 1  15/340 (4.41%)  17/338 (5.03%) 
Vascular disorders     
Hypertension * 1  23/340 (6.76%)  12/338 (3.55%) 
*
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
Layout table for Results Point of Contact information
Name/Title: Medical Leader
Organization: Janssen Infectious Diseases BVBA
Phone: 32 14 641418
Layout table for additonal information
Responsible Party: Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier: NCT00543725    
Obsolete Identifiers: NCT00614692
Other Study ID Numbers: CR002704
TMC278-TIDP6-C215 ( Other Identifier: Tibotec Pharmaceuticals, Ireland )
First Submitted: October 11, 2007
First Posted: October 15, 2007
Results First Submitted: June 14, 2011
Results First Posted: July 12, 2011
Last Update Posted: April 1, 2016