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GRACE: A Study to Compare the Effectiveness, Safety and Tolerability of PREZISTA (Darunavir)/Ritonavir by Gender and Race When Administered With Other Antiretroviral Medications in Human Immunodeficiency Virus (HIV) Positive Women and Men.

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ClinicalTrials.gov Identifier: NCT00381303
Recruitment Status : Completed
First Posted : September 27, 2006
Results First Posted : October 19, 2010
Last Update Posted : April 21, 2014
Sponsor:
Collaborator:
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Information provided by (Responsible Party):
Tibotec, Inc

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions HIV
Infectious
Interventions Drug: darunavir
Drug: ritonavir
Enrollment 429
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Female Male
Hide Arm/Group Description darunavir 600 milligram (mg) twice daily dosing (bid) for 48 weeks administered with ritonavir 100 mg bid for 48 weeks. darunavir 600 mg twice bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
Period Title: Overall Study
Started 287 142
Completed 193 109
Not Completed 94 33
Reason Not Completed
Lost to Follow-up             25             9
AE/HIV-related event             22             6
Non-Adherence             13             6
Withdrawal by Subject             13             6
Virologic failure             6             4
Ineligible to continue the trial             2             1
Pregnancy             2             0
Physician Decision             1             0
Physician's decision to close the site             3             1
Subject moved out of state             2             0
Subject taking too many different meds             1             0
No virologic response by week 12             1             0
Subject was too busy for appointments             1             0
Subject did not continue visits             1             0
Subject primary physician's decision             1             0
Arm/Group Title Female Male Total
Hide Arm/Group Description darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks. darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks. Total of all reporting groups
Overall Number of Baseline Participants 287 142 429
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 287 participants 142 participants 429 participants
43
(19 to 78)
45
(21 to 78)
43
(19 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 287 participants 142 participants 429 participants
Female
287
 100.0%
0
   0.0%
287
  66.9%
Male
0
   0.0%
142
 100.0%
142
  33.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 287 participants 142 participants 429 participants
Black 191 73 264
Caucasian/White 34 31 65
Hispanic 60 36 96
Asian 0 2 2
Other 2 0 2
Previous Antiretroviral (ARV) Experience: Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 287 participants 142 participants 429 participants
NNRTI: < 1 drug count 83 32 115
NNRTI: >= 1 drug count 204 110 314
Previous ARV experience: Protease inhibitor (PI)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 287 participants 142 participants 429 participants
PI: <2 119 50 169
PI: >=2 168 92 260
CD4+ cell count  
Median (Full Range)
Unit of measure:  cells/L
Number Analyzed 287 participants 142 participants 429 participants
210
(1 to 868)
175
(2 to 1125)
200
(1 to 1125)
Plasma log10 copies/mL VL HIV-1 RNA  
Mean (Standard Deviation)
Unit of measure:  copies/mL
Number Analyzed 287 participants 142 participants 429 participants
4.65  (0.883) 4.73  (0.856) 4.67  (0.874)
Time since HIV-infection diagnosis  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 287 participants 142 participants 429 participants
10.78
(0.29 to 27.62)
11.91
(1.21 to 23.76)
11.3
(0.29 to 27.62)
1.Primary Outcome
Title Number of Viral Load (VL) < 50 HIV-1 RNA Copies/mL (Time to Loss of Virologic Response[TLOVR]) Subjects by Sex
Hide Description TLOVR - responders/non-responders per FDA TLOVR response algorithm. A subject was considered a responder at that time point and that subsequent. A subject was considered a non-responder at a time point in the following situations: discontinued treatment at that time point, a rebound value at that time point and that subsequent or at that time point and that followed by treatment discontinuation, intermittent missing values were considered a response if the immediately preceding and following visits were a response, rebound at earlier time point, or any new, unplanned ARV except in tolerability
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT)
Arm/Group Title Female Male
Hide Arm/Group Description:
darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
Overall Number of Participants Analyzed 287 142
Measure Type: Number
Unit of Measure: participants
146 83
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Female, Male
Comments

Confidence interval of the difference in proportion of response between two sexes estimated by:

  • Application of delta method to be obtained Standard Error (SE)
  • Calculation of lower and upper bound using normal approximation to the difference in response rates
Type of Statistical Test Non-Inferiority or Equivalence
Comments Test for non-inferiority (Delta=15%)
Statistical Test of Hypothesis P-Value 0.30
Comments P-Value for difference (Female - Male): Test for non-inferiority (Delta=15%)
Method Regression, Logistic
Comments Estimates from logistic regression analysis include baseline log10 viral load and baseline CD4 cell count as covariates and gender as a factor.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.6
Confidence Interval (2-Sided) 95%
-19.85 to 0.68
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.052
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of TLOVR Non-virologic Failure (VF) Censored - VL < 50 HIV-1 RNA Subjects by Sex
Hide Description TLOVR non-virologic failure (VF) censored. This imputation method differs from the TLOVR algorithm, because subjects that dropped out for reasons other than virologic failure were censored from the time of discontinuation onwards.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
TLOVR non-virologic failure (VF) censored
Arm/Group Title Female Male
Hide Arm/Group Description:
darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
Overall Number of Participants Analyzed 200 113
Measure Type: Number
Unit of Measure: participants
146 83
3.Secondary Outcome
Title Number of VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects by Race
Hide Description Intention to Treat population (ITT)
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Black Caucasian Hispanic Asian Other
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 264 65 96 2 2
Measure Type: Number
Unit of Measure: participants
128 39 59 2 1
4.Secondary Outcome
Title Number of Etravirine-TMC125 (ETR) Subgroup- VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects
Hide Description The Etravirine-TMC125 (ETR Subgroup population was defined as all ITT subjects who took at least 1 dose of ETR)
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ETR Subgroup- Intention to Treat population (ITT)
Arm/Group Title Female Male Black Caucasian Hispanic Asian Other
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 119 88 133 34 36 2 2
Measure Type: Number
Unit of Measure: participants
69 54 74 21 25 2 1
5.Secondary Outcome
Title Descriptive Statistics of [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA by Race
Hide Description TLOVR non-virologic failure (VF) censored. This imputation method differs from the TLOVR algorithm, because subjects that dropped out for reasons other than virologic failure were censored from the time of discontinuation onwards.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
TLOVR Non-virologic Failure(VF) Censored
Arm/Group Title Black Caucasian Hispanic Asian Other
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 186 50 74 2 1
Measure Type: Number
Unit of Measure: participants
128 39 59 2 1
6.Secondary Outcome
Title Descriptive Statistics of ETR Subgroup [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA
Hide Description

The Etravirine-TMC125 (ETR Subgroup population was defined as all ITT subjects who took at least 1 dose of ETR)

TLOVR non-virologic failure(VF) censored. This imputation method differs from the TLOVR algorithm, because subjects that dropped out for reasons other than virologic failure were censored from the time of discontinuation onwards.

Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Etravirine-TMC125 (ETR) Subgroup [TLOVR Non-virologic Failure (VF) Censored]
Arm/Group Title Female Male Black Caucasian Hispanic Asian Other
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 87 74 102 26 30 2 1
Measure Type: Number
Unit of Measure: participants
69 54 74 21 25 2 1
7.Secondary Outcome
Title Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using Observed Values
Hide Description Observed obsevations have no imputation methods applied.
Time Frame Baseline, Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Female Male Black Caucasian Hispanic Asian Other
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 188 105 173 47 70 2 1
Mean (Standard Error)
Unit of Measure: x10^6 cells/L
152  (11.2) 122  (12.3) 143  (10.8) 151  (23.8) 133  (17.0) 45  (24.5) 179
8.Secondary Outcome
Title Descriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Using Observed Values
Hide Description The Etravirine-TMC125 (ETR Subgroup population was defined as all ITT subjects who took at least 1 dose of ETR)
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Etravirine-TMC125 (ETR Subgroup) Intention to Treat population (ITT)
Arm/Group Title Female Male Black Caucasian Hispanic Asian Other
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 80 67 93 25 26 2 1
Mean (Standard Error)
Unit of Measure: x10^6 cells/L
136  (15.8) 108  (15.1) 135  (13.5) 111  (26.7) 98  (29.8) 45  (24.5) 179
9.Secondary Outcome
Title Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using the Imputation Method of Last Observation Carried Forward (LOCF)
Hide Description Last Observation Carried Forward (LOCF) imputation method applied.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT LOCF
Arm/Group Title Female Male Black Caucasian Hispanic Asian Other
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 287 142 264 65 96 2 2
Mean (Standard Error)
Unit of Measure: x10^6 cells/L
112  (8.8) 103  (11.2) 109  (8.9) 110  (20.4) 109  (13.5) 45  (24.5) 138  (41.0)
10.Secondary Outcome
Title Descriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Count Using the Imputation Method of LOCF
Hide Description The Etravirine-TMC125 (ETR Subgroup population was defined as all ITT subjects who took at least 1 dose of ETR). The Last Observation Carried Forward (LOCF) imputation method was applied.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Etravirine-TMC125 (ETR Subgroup) Intention to Treat population (ITT)
Arm/Group Title Female Male Black Caucasian Hispanic Asian Other
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 119 88 133 34 36 2 2
Mean (Standard Error)
Unit of Measure: x10^6 Cells/L
107  (12.7) 98  (14.0) 113  (12.1) 84  (21.7) 90  (22.6) 45  (24.5) 138  (41.0)
Time Frame 48 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Female Male
Hide Arm/Group Description darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks. darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
All-Cause Mortality
Female Male
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Female Male
Affected / at Risk (%) Affected / at Risk (%)
Total   47/287 (16.38%)   33/142 (23.24%) 
Blood and lymphatic system disorders     
Anemia * 1  1/287 (0.35%)  1/142 (0.70%) 
Febrile Neutropenia * 1  1/287 (0.35%)  1/142 (0.70%) 
Cardiac disorders     
Acute Myocardial Infarction * 1  0/287 (0.00%)  1/142 (0.70%) 
Angina Pectoris * 1  2/287 (0.70%)  2/142 (1.41%) 
Cardiac Failures Congestive * 1  1/287 (0.35%)  0/142 (0.00%) 
Cardiac Tamponade * 1  1/287 (0.35%)  0/142 (0.00%) 
Myocardial Infarction * 1  2/287 (0.70%)  2/142 (1.41%) 
Ventricular Tachycardia * 1  1/287 (0.35%)  0/142 (0.00%) 
Gastrointestinal disorders     
Acquired Oesophageal Web * 1  1/287 (0.35%)  0/142 (0.00%) 
Diarrhoea * 1  0/287 (0.00%)  1/142 (0.70%) 
Gatrointestinal Haemorrhage * 1  0/287 (0.00%)  1/142 (0.70%) 
Oesophageal Ulcer * 1  0/287 (0.00%)  1/142 (0.70%) 
Oesophagitis * 1  1/287 (0.35%)  0/142 (0.00%) 
Pancreatitis * 1  0/287 (0.00%)  1/142 (0.70%) 
Pancreatitis Acute * 1  1/287 (0.35%)  0/142 (0.00%) 
Vomiting * 1  0/287 (0.00%)  1/142 (0.70%) 
General disorders     
Chest Pain * 1  0/287 (0.00%)  4/142 (2.82%) 
Multi-Organ Failure * 1  0/287 (0.00%)  1/142 (0.70%) 
Non-Cardiac Chest Pain * 1  2/287 (0.70%)  2/142 (1.41%) 
Hepatobiliary disorders     
Cholelithiasis * 1  0/287 (0.00%)  1/142 (0.70%) 
Hepatitis * 1  1/287 (0.35%)  1/142 (0.70%) 
Immune system disorders     
Drug Hypersensitivity * 1  1/287 (0.35%)  1/142 (0.70%) 
Hypersensitivity * 1  1/287 (0.35%)  1/142 (0.70%) 
Infections and infestations     
Abscess * 1  1/287 (0.35%)  1/142 (0.70%) 
Abcess Limb * 1  1/287 (0.35%)  1/142 (0.70%) 
Bacterial Pyelonephritis * 1  2/287 (0.70%)  2/142 (1.41%) 
Bacterial Sepsis * 1  1/287 (0.35%)  1/142 (0.70%) 
Bartonellosis * 1  0/287 (0.00%)  1/142 (0.70%) 
Bronchitis * 1  0/287 (0.00%)  1/142 (0.70%) 
Cellulitis * 1  2/287 (0.70%)  2/142 (1.41%) 
Clostridium Difficile Colitis * 1  1/287 (0.35%)  1/142 (0.70%) 
Cytomegalovirus Oesophagitis * 1  0/287 (0.00%)  0/142 (0.00%) 
Dengue Fever * 1  0/287 (0.00%)  1/142 (0.70%) 
Gastroenteritis * 1  1/287 (0.35%)  0/142 (0.00%) 
Gastroenteriris Cryptosporidial * 1  0/287 (0.00%)  1/142 (0.70%) 
Gonorrhoea * 1  1/287 (0.35%)  0/142 (0.00%) 
Herpes Zoster Ophthalmic * 1  1/287 (0.35%)  0/142 (0.00%) 
Lung Infection Pseudomonal * 1  0/287 (0.00%)  1/142 (0.70%) 
Meningitis Aseptic * 1  0/287 (0.00%)  0/142 (0.00%) 
Meningitis Tuberculous * 1  1/287 (0.35%)  0/142 (0.00%) 
Meningitis Viral * 1  1/287 (0.35%)  1/142 (0.70%) 
Oesophageal Candidiasis * 1  1/287 (0.35%)  0/142 (0.00%) 
Pneumocystis Jiroveci Pneumonia * 1  1/287 (0.35%)  4/142 (2.82%) 
Pneumonia * 1  10/287 (3.48%)  1/142 (0.70%) 
Pneumonia Bacterial * 1  0/287 (0.00%)  1/142 (0.70%) 
Pneumonia Legionella * 1  1/287 (0.35%)  0/142 (0.00%) 
Rectal Abcess * 1  0/287 (0.00%)  1/142 (0.70%) 
Septic Arthritis Staphylococcal * 1  0/287 (0.00%)  1/142 (0.70%) 
Sinusitus * 1  0/287 (0.00%)  0/142 (0.00%) 
Staphylococcal Abcess * 1  1/287 (0.35%)  0/142 (0.00%) 
Staphylococcal Bacteraemia * 1  0/287 (0.00%)  1/142 (0.70%) 
Staphylococcal Infection * 1  1/287 (0.35%)  1/142 (0.70%) 
Subcutaneous Abscess * 1  0/287 (0.00%)  1/142 (0.70%) 
Toxoplasmosis * 1  1/287 (0.35%)  0/142 (0.00%) 
Upper Respiratory Tract Infection * 1  2/287 (0.70%)  0/142 (0.00%) 
Urinary Tract Infection * 1  2/287 (0.70%)  0/142 (0.00%) 
Viral Infection * 1  1/287 (0.35%)  0/142 (0.00%) 
Accidental Overdose * 1  0/287 (0.00%)  1/142 (0.70%) 
Injury, poisoning and procedural complications     
Operative Haemorrhage * 1  1/287 (0.35%)  0/142 (0.00%) 
Investigations     
Alanine Amino Transferase Increased * 1  0/287 (0.00%)  1/142 (0.70%) 
Aspartate Amino Transferase Increased * 1  1/287 (0.35%)  1/142 (0.70%) 
Blood Amylase Increased * 1  0/287 (0.00%)  1/142 (0.70%) 
Blood Lactic Acid Increased * 1  0/287 (0.00%)  1/142 (0.70%) 
Transaminases Increased * 1  1/287 (0.35%)  1/142 (0.70%) 
Metabolism and nutrition disorders     
Hypokalaemia * 1  0/287 (0.00%)  1/142 (0.70%) 
Lactic Acidosis * 1  0/287 (0.00%)  1/142 (0.70%) 
Musculoskeletal and connective tissue disorders     
Osteonecrosis * 1  1/287 (0.35%)  0/142 (0.00%) 
Rhabdomyolysis * 1  0/287 (0.00%)  0/142 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Anal Cancer Stage 0 * 1  1/287 (0.35%)  0/142 (0.00%) 
Non-Small Cell Lung Cancer * 1  0/287 (0.00%)  1/142 (0.70%) 
Vulval Cancer * 1  1/287 (0.35%)  0/142 (0.00%) 
Nervous system disorders     
Convulsion * 1  1/287 (0.35%)  0/142 (0.00%) 
Headache * 1  1/287 (0.35%)  1/142 (0.70%) 
Migraine * 1  0/287 (0.00%)  1/142 (0.70%) 
Status Epilepticus * 1  0/287 (0.00%)  1/142 (0.70%) 
Pregnancy, puerperium and perinatal conditions     
Pre-Eclampsia * 1  0/287 (0.00%)  0/142 (0.00%) 
Premature Labour * 1  0/287 (0.00%)  0/142 (0.00%) 
Psychiatric disorders     
Alcoholism * 1  1/287 (0.35%)  1/142 (0.70%) 
Catatonia * 1  1/287 (0.35%)  1/142 (0.70%) 
Conversion Disorder * 1  1/287 (0.35%)  1/142 (0.70%) 
Delirium * 1  1/287 (0.35%)  1/142 (0.70%) 
Dependence * 1  1/287 (0.35%)  1/142 (0.70%) 
Depression * 1  2/287 (0.70%)  2/142 (1.41%) 
Major Depression * 1  1/287 (0.35%)  1/142 (0.70%) 
Suicide Attempt * 1  2/287 (0.70%)  2/142 (1.41%) 
Renal and urinary disorders     
Nephrolithiasis * 1  0/287 (0.00%)  1/142 (0.70%) 
Renal Failure * 1  0/287 (0.00%)  1/142 (0.70%) 
Renal Failure Acute * 1  2/287 (0.70%)  1/142 (0.70%) 
Respiratory, thoracic and mediastinal disorders     
Asthma * 1  2/287 (0.70%)  1/142 (0.70%) 
Chronic Obstructive Pulmonary Disease * 1  2/287 (0.70%)  2/142 (1.41%) 
Hypoxia * 1  0/287 (0.00%)  1/142 (0.70%) 
Pulmonary Embolism * 1  0/287 (0.00%)  2/142 (1.41%) 
Respiratory Failure * 1  1/287 (0.35%)  0/142 (0.00%) 
Skin and subcutaneous tissue disorders     
Angioneurotic Oedema * 1  2/287 (0.70%)  0/142 (0.00%) 
Rash * 1  1/287 (0.35%)  2/142 (1.41%) 
Urticaria * 1  1/287 (0.35%)  0/142 (0.00%) 
Social circumstances     
Drug Abuser * 1  0/287 (0.00%)  1/142 (0.70%) 
Vascular disorders     
Deep Vein Thrombosis * 1  0/287 (0.00%)  2/142 (1.41%) 
Haemorrhage * 1  1/287 (0.35%)  0/142 (0.00%) 
Thrombosis * 1  1/287 (0.35%)  0/142 (0.00%) 
Vascular Insufficiency * 1  0/287 (0.00%)  1/142 (0.70%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Female Male
Affected / at Risk (%) Affected / at Risk (%)
Total   73/287 (25.44%)   33/142 (23.24%) 
Blood and lymphatic system disorders     
Lymphadenopathy * 1  20/287 (6.97%)  8/142 (5.63%) 
Gastrointestinal disorders     
Diarrhoea * 1  47/287 (16.38%)  31/142 (21.83%) 
Nausea * 1  70/287 (24.39%)  20/142 (14.08%) 
Vomiting * 1  33/287 (11.50%)  9/142 (6.34%) 
General disorders     
Oedema Peripheral * 1  16/287 (5.57%)  6/142 (4.23%) 
Pyrexia * 1  14/287 (4.88%)  12/142 (8.45%) 
Infections and infestations     
Bronchitis * 1  18/287 (6.27%)  7/142 (4.93%) 
Oral Candidiasis * 1  19/287 (6.62%)  7/142 (4.93%) 
Upper Respiratory Tract Infection * 1  30/287 (10.45%)  11/142 (7.75%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  19/287 (6.62%)  7/142 (4.93%) 
Back Pain * 1  16/287 (5.57%)  11/142 (7.75%) 
Nervous system disorders     
Headache * 1  26/287 (9.06%)  11/142 (7.75%) 
Psychiatric disorders     
Depression * 1  15/287 (5.23%)  10/142 (7.04%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  27/287 (9.41%)  12/142 (8.45%) 
Skin and subcutaneous tissue disorders     
Pruritus * 1  19/287 (6.62%)  5/142 (3.52%) 
Rash * 1  23/287 (8.01%)  11/142 (7.75%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
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.
If TTCA does not publish within 12 months after study conclusion or after TTCA confirms there will be no multicenter publication, Institution may publish their results from their site individually, provided TTCA has 60 day review for confidentiality and additional 60 day delay for patent application.
Results Point of Contact
Name/Title: Vice President, Tibotec Therapeutics Clinical Affairs
Organization: Tibotec Therapeutics Clinical Affairs (TTCA), Division of Centocor Ortho Biotech Services, LLC
Phone: 877-732-2488
Responsible Party: Tibotec, Inc
ClinicalTrials.gov Identifier: NCT00381303     History of Changes
Other Study ID Numbers: CR011869
TMC114HIV3004
First Submitted: September 26, 2006
First Posted: September 27, 2006
Results First Submitted: November 24, 2009
Results First Posted: October 19, 2010
Last Update Posted: April 21, 2014