Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Open-label Trial With TMC125 in Patients Who Have Virologically Failed in a DUET Trial (TMC125-C206 or TMC125-C216).

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00359021
Recruitment Status : Completed
First Posted : August 1, 2006
Results First Posted : March 7, 2013
Last Update Posted : May 16, 2014
Sponsor:
Information provided by (Responsible Party):
Tibotec Pharmaceuticals, Ireland

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV-1
Intervention Drug: TMC125
Enrollment 503
Recruitment Details  
Pre-assignment Details Participants with human immunodeficiency virus - type 1 (HIV-1) infection were enrolled in this study from DUET Study TMC125-C206 or TMC125-C216 and met the definition of virologic failure at Week 24 or later in these studies, or who completed one of the DUET studies after 96 weeks of treatment.
Arm/Group Title DUET PLACEBO DUET TMC125
Hide Arm/Group Description Participants who received Placebo in a previous DUET study and received open-label treatment with 200 mg twice daily etravirine, also known as TMC125 (ETR) and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-naïve participants. Participants who received etravirine, also known as TMC125 (ETR) in a previous DUET study and received open-label treatment with 200 mg twice daily ETR and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-experienced participants.
Period Title: Overall Study
Started 256 247
Completed 175 195
Not Completed 81 52
Reason Not Completed
Adverse Event             26             8
Subject Non-Compliant             1             2
Subject Ineligible To Continue The Trial             1             0
Subject Reached A Virologic Endpoint             45             32
Withdrawal by Subject             2             9
Lost to Follow-up             1             0
Other             4             1
Pregnancy             1             0
Arm/Group Title DUET PLACEBO DUET TMC125 Total
Hide Arm/Group Description Participants who received Placebo in a previous DUET study and received open-label treatment with 200 mg twice daily etravirine, also known as TMC125 (ETR) and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-naïve participants. Participants who received etravirine, also known as TMC125 (ETR) in a previous DUET study and received open-label treatment with 200 mg twice daily ETR and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-experienced participants. Total of all reporting groups
Overall Number of Baseline Participants 256 247 503
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 256 participants 247 participants 503 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
252
  98.4%
245
  99.2%
497
  98.8%
>=65 years
4
   1.6%
2
   0.8%
6
   1.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 256 participants 247 participants 503 participants
46.9  (8.28) 46.6  (7.01) 46.7  (7.68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 256 participants 247 participants 503 participants
Female
27
  10.5%
37
  15.0%
64
  12.7%
Male
229
  89.5%
210
  85.0%
439
  87.3%
1.Primary Outcome
Title The Number of Participants Experiencing Adverse Events
Hide Description The table below provides the number of participants who experienced Serious Adverse Events (SAEs) and Other Adverse Events (except SAEs) that started or worsened in severity during the overall TMC125-C217 treatment period. The duration of treatment ranged per patient from 1 week to 180 weeks, with a median of 62 weeks.
Time Frame 1 week to 180 weeks, with a median of 62 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis was carried out on the ITT population, which included all participants who received at least one dose of investigational medication.
Arm/Group Title DUET PLACEBO DUET TMC125 All Participants
Hide Arm/Group Description:
Participants who received Placebo in a previous DUET study received open-label treatment with 200 mg twice daily etravirine, also known as TMC125 (ETR) and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-naïve participants.
Participants who received etravirine, also known as TMC125 (ETR) in a previous DUET study and received open-label treatment with 200 mg twice daily ETR and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-experienced participants.
DUET Placebo + DUET TMC125
Overall Number of Participants Analyzed 256 247 503
Measure Type: Number
Unit of Measure: Participants
Serious Adverse Events (SAEs) 46 42 88
Other Adverse Events (AEs) 160 137 297
2.Secondary Outcome
Title The Percentage of Participants With Virologic Outcomes Over Time
Hide Description The table below shows the percentage of participants with virologic suppression (< 50 copies/mL), the percentage of participants who were virologic failures (VF) (>50 copies/mL, discontinued prior to time X for reasons of VF or for other reasons, except for VF or adverse event, with a last viral load >50 copies/mL), and the percentage of participants with no viral load (VL) data available over time (ie, at Weeks 24, 48, and 96).
Time Frame Weeks 24, 48, and 96
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population was used as the primary analysis population for the efficacy analysis and included all participants who took at least one dose of etravirine (ETR) (also known as TMC125) in the TMC125-C217 study.
Arm/Group Title DUET PLACEBO DUET TMC125
Hide Arm/Group Description:
Participants who received Placebo in a previous DUET study received open-label treatment with 200 mg twice daily etravirine, also known as TMC125 (ETR) and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-naïve participants.
Participants who received etravirine, also known as TMC125 (ETR) in a previous DUET study and received open-label treatment with 200 mg twice daily ETR and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-experienced participants.
Overall Number of Participants Analyzed 256 247
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 24 - Virologic Response (<50 cop/mL) 43.0 62.3
Week 24 - Virologic Failure 46.9 31.6
Week 24 - No VL Data available 10.2 6.1
Week 48 - Virologic Response (<50 cop/mL) 35.2 44.5
Week 48 - Virologic Failure 50.4 31.2
Week 48 - No VL Data available 14.5 24.3
Week 96 -Virologic Response (<50 cop/mL) 7.4 4.5
Week 96 - Virologic Failure 48.0 27.5
Week 96 - No VL Data available 44.5 68.0
3.Secondary Outcome
Title Change in Plasma Viral Load Versus Baseline (ie, Mean Change in log10 Plasma Viral Load From Baseline Over Time)
Hide Description In the table below, the total number of participants analyzed in the Duet Placebo and Duet TMC125 groups, respectively at each time point were: Baseline (256;247 participants), Week 24 (251;240 participants), Week 48 (235;192 participants), and Week 96 (123;69 participants).
Time Frame Baseline, Week 24, Week 48, and Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population was used as the primary analysis population for the efficacy analysis and included all participants who took at least one dose of etravirine (ETR) (also known as TMC125) in the TMC125-C217 study.
Arm/Group Title DUET PLACEBO DUET TMC125
Hide Arm/Group Description:
Participants who received Placebo in a previous DUET study received open-label treatment with 200 mg twice daily etravirine, also known as TMC125 (ETR) and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-naïve participants.
Participants who received etravirine, also known as TMC125 (ETR) in a previous DUET study and received open-label treatment with 200 mg twice daily ETR and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-experienced participants.
Overall Number of Participants Analyzed 256 247
Mean (95% Confidence Interval)
Unit of Measure: log10 copies/mL
Week 24
-0.8
(-0.93 to -0.63)
0
(-0.11 to 0.03)
Week 48
-0.7
(-0.86 to -0.54)
-0.1
(-0.16 to -0.02)
Week 96
-0.5
(-0.66 to -0.30)
-0.2
(-0.38 to -0.04)
Time Frame 07-Jun-2006 to 24-Jan-2012.
Adverse Event Reporting Description All "Serious Adverse Events (SAEs)" emerging during the TMC125-C217 treatment period are reported below; "Other Adverse Events (not including SAEs)" provided below occurred in at least 0.5% of participants. The duration of the TMC125 treatment period ranged per patient from 1 week to 180 weeks, with a median of 62 weeks.
 
Arm/Group Title DUET PLACEBO DUET TMC125 All Participants
Hide Arm/Group Description Participants who received Placebo in a previous DUET study and received open-label treatment with 200 mg twice daily etravirine, also known as TMC125 (ETR) and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-naïve participants. Participants who received etravirine, also known as TMC125 (ETR) in a previous DUET study and received open-label treatment with 200 mg twice daily ETR and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-experienced participants. Participants who received placebo or TMC125 in a previous DUET study (DUET Placebo + DUET TMC125).
All-Cause Mortality
DUET PLACEBO DUET TMC125 All Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
DUET PLACEBO DUET TMC125 All Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   46/256 (17.97%)   42/247 (17.00%)   88/503 (17.50%) 
Blood and lymphatic system disorders       
Anaemia * 1  2/256 (0.78%)  2/247 (0.81%)  4/503 (0.80%) 
Febrile bone marrow aplasia * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Febrile neutropenia * 1  2/256 (0.78%)  0/247 (0.00%)  2/503 (0.40%) 
Haemorrhagic diathesis * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Pancytopenia * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Thrombocytopenia * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Thrombotic thrombocytopenic purpura * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Cardiac disorders       
Angina unstable * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Atrial fibrillation * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Atrial flutter * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Bradycardia * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Cardiac failure * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Cardio-respiratory arrest * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Cardiopulmonary failure * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Coronary artery disease * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Coronary artery occlusion * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Myocardial infarction * 1  2/256 (0.78%)  2/247 (0.81%)  4/503 (0.80%) 
Pericarditis * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Gastrointestinal disorders       
Abdominal pain * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Ascites * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Colitis * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Diarrhoea * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Dysphagia * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Eructation * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Gastric ulcer * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Haematemesis * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Haemorrhoids * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Hernial eventration * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Intestinal polyp * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Mesenteric vein thrombosis * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Pancreatitis * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Proctitis * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Rectal ulcer * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Subileus * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
General disorders       
Asthenia * 1  2/256 (0.78%)  0/247 (0.00%)  2/503 (0.40%) 
Non-cardiac chest pain * 1  1/256 (0.39%)  1/247 (0.40%)  2/503 (0.40%) 
Oedema peripheral * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Pyrexia * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Hepatobiliary disorders       
Chronic hepatic failure * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Immune system disorders       
Drug hypersensitivity * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Infections and infestations       
Anal abscess * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Appendicitis * 1  1/256 (0.39%)  1/247 (0.40%)  2/503 (0.40%) 
Bronchopneumonia * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Cellulitis * 1  3/256 (1.17%)  0/247 (0.00%)  3/503 (0.60%) 
Cerebral toxoplasmosis * 1  1/256 (0.39%)  1/247 (0.40%)  2/503 (0.40%) 
Clostridium difficile colitis * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Cryptococcosis * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Cytomegalovirus chorioretinitis * 1  1/256 (0.39%)  1/247 (0.40%)  2/503 (0.40%) 
Cytomegalovirus colitis * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Cytomegalovirus infection * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Cytomegalovirus myelomeningoradiculitis * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Gastroenteritis * 1  2/256 (0.78%)  2/247 (0.81%)  4/503 (0.80%) 
HIV infection * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Hepatitis c * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Herpes simplex * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Herpes zoster * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Histoplasmosis * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Histoplasmosis disseminated * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Keratitis fungal * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Localised infection * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Meningitis * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Mycobacterium avium complex infection * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Oesophageal candidiasis * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Oral candidiasis * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Papilloma viral infection * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Pneumocystis jiroveci pneumonia * 1  3/256 (1.17%)  0/247 (0.00%)  3/503 (0.60%) 
Pneumonia * 1  5/256 (1.95%)  4/247 (1.62%)  9/503 (1.79%) 
Pneumonia influenzal * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Postoperative wound infection * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Pyomyositis * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Pyothorax * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Scrotal abscess * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Sepsis * 1  2/256 (0.78%)  2/247 (0.81%)  4/503 (0.80%) 
Staphylococcal bacteraemia * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Staphylococcal sepsis * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Strongyloidiasis * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Tuberculosis of central nervous system * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Urinary tract infection * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Urinary tract infection fungal * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Injury, poisoning and procedural complications       
Subdural haematoma * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Wrist fracture * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Investigations       
Arteriogram coronary * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Blood amylase increased * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Blood creatinine increased * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Haemoglobin decreased * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Lipase increased * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Weight decreased * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Metabolism and nutrition disorders       
Dehydration * 1  2/256 (0.78%)  1/247 (0.40%)  3/503 (0.60%) 
Gout * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Hypertriglyceridaemia * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Hypokalaemia * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Hyponatraemia * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Back pain * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Muscular weakness * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Osteoarthritis * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Osteonecrosis * 1  1/256 (0.39%)  2/247 (0.81%)  3/503 (0.60%) 
Osteoporosis * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Pain in extremity * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Pathological fracture * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Anal cancer * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Female reproductive tract carcinoma in situ * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Haemangioma of liver * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Hodgkin's disease * 1  0/256 (0.00%)  2/247 (0.81%)  2/503 (0.40%) 
Lymphoma * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Squamous cell carcinoma * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Uterine leiomyoma * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Nervous system disorders       
Cerebrovascular accident * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Coma * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Dementia * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Hypoaesthesia * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Lacunar infarction * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Post herpetic neuralgia * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Transient ischaemic attack * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Psychiatric disorders       
Confusional state * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Depression * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Generalised anxiety disorder * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Major depression * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Mood disorder due to a general medical condition * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Psychotic disorder * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Renal and urinary disorders       
Renal failure * 1  2/256 (0.78%)  0/247 (0.00%)  2/503 (0.40%) 
Renal failure acute * 1  1/256 (0.39%)  2/247 (0.81%)  3/503 (0.60%) 
Renal impairment * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Reproductive system and breast disorders       
Cervical dysplasia * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Skin and subcutaneous tissue disorders       
Night sweats * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Rash macular * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Surgical and medical procedures       
Abdominal hernia repair * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Abdominoplasty * 1  0/256 (0.00%)  1/247 (0.40%)  1/503 (0.20%) 
Breast cosmetic surgery * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Liposuction * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Vascular disorders       
Hypertension * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
Phlebitis * 1  1/256 (0.39%)  0/247 (0.00%)  1/503 (0.20%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
DUET PLACEBO DUET TMC125 All Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   160/256 (62.50%)   137/247 (55.47%)   297/503 (59.05%) 
Gastrointestinal disorders       
Diarrhoea * 1  32/256 (12.50%)  24/247 (9.72%)  56/503 (11.13%) 
Nausea * 1  20/256 (7.81%)  15/247 (6.07%)  35/503 (6.96%) 
General disorders       
Injection site nodule * 1  14/256 (5.47%)  8/247 (3.24%)  22/503 (4.37%) 
Pyrexia * 1  13/256 (5.08%)  6/247 (2.43%)  19/503 (3.78%) 
Infections and infestations       
Bronchitis * 1  18/256 (7.03%)  12/247 (4.86%)  30/503 (5.96%) 
Herpes simplex * 1  32/256 (12.50%)  17/247 (6.88%)  49/503 (9.74%) 
Influenza * 1  18/256 (7.03%)  18/247 (7.29%)  36/503 (7.16%) 
Nasopharyngitis * 1  21/256 (8.20%)  15/247 (6.07%)  36/503 (7.16%) 
Oral candidiasis * 1  23/256 (8.98%)  14/247 (5.67%)  37/503 (7.36%) 
Sinusitis * 1  19/256 (7.42%)  23/247 (9.31%)  42/503 (8.35%) 
Upper respiratory tract infection * 1  14/256 (5.47%)  11/247 (4.45%)  25/503 (4.97%) 
Urinary tract infection * 1  14/256 (5.47%)  8/247 (3.24%)  22/503 (4.37%) 
Metabolism and nutrition disorders       
Hypertriglyceridaemia * 1  12/256 (4.69%)  15/247 (6.07%)  27/503 (5.37%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  7/256 (2.73%)  14/247 (5.67%)  21/503 (4.17%) 
Nervous system disorders       
Headache * 1  18/256 (7.03%)  10/247 (4.05%)  28/503 (5.57%) 
Psychiatric disorders       
Insomnia * 1  13/256 (5.08%)  7/247 (2.83%)  20/503 (3.98%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  12/256 (4.69%)  14/247 (5.67%)  26/503 (5.17%) 
Skin and subcutaneous tissue disorders       
Rash * 1  24/256 (9.38%)  4/247 (1.62%)  28/503 (5.57%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.1
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 investigator agrees that before he/she publishes any results of this trial, he/she shall provide the sponsor with at least 45 days for full review of the pre-publication manuscript prior to submission of the manuscript to the publisher.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: SENIOR DIRECTOR R&D
Organization: Tibotec
Phone: 1 609 730-7548
Layout table for additonal information
Responsible Party: Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier: NCT00359021    
Other Study ID Numbers: CR002740
TMC125-C217 ( Other Identifier: Tibotec Pharmaceuticals )
TMC125-C206 ( Other Identifier: Tibotec Pharmaceuticals )
TMC125-C216 ( Other Identifier: Tibotec Pharmaceuticals )
First Submitted: July 28, 2006
First Posted: August 1, 2006
Results First Submitted: January 29, 2013
Results First Posted: March 7, 2013
Last Update Posted: May 16, 2014