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Trial record 32 of 35 for:    " August 29, 2007":" September 28, 2007"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

A Study to Compare Effectiveness and Safety of Darunavir/Ritonavir (DRV/Rtv) 800mg/100mg Once Daily Versus DRV/Rtv 600mg/100mg Twice Daily in Early Treatment-Experienced HIV-1 Infected Patients (ODIN) (ODIN)

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ClinicalTrials.gov Identifier: NCT00524368
Recruitment Status : Completed
First Posted : September 3, 2007
Results First Posted : September 22, 2010
Last Update Posted : February 15, 2013
Sponsor:
Information provided by (Responsible Party):
Tibotec Pharmaceuticals, Ireland

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Human Immunodeficiency Virus - Type 1
Interventions Drug: Darunavir (DRV)
Drug: Ritonavir (rtv)
Enrollment 590
Recruitment Details One hundred thirteen investigators in 21 countries participated in this study.
Pre-assignment Details In total 1092 participants were screened, of which 590 participants were randomly assigned and treated (294 participants were treated with DRV/rtv 800/100 mg once daily, and 296 participants with DRV/rtv 600/100 mg twice daily.
Arm/Group Title DRV/Rtv 800/100 mg Once Daily DRV/Rtv 600/100 mg Twice Daily
Hide Arm/Group Description Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
Period Title: Overall Study
Started 294 296
Completed 253 248
Not Completed 41 48
Reason Not Completed
Adverse Event             10             12
Lost to Follow-up             9             13
Withdrawal by Subject             4             5
Non-compliant             8             9
Reached a Virologic Endpoint             3             2
Sponsor's Decision             2             0
Ineligible to Continue the study             2             5
Other             3             2
Arm/Group Title DRV/Rtv 800/100 mg Once Daily DRV/Rtv 600/100 mg Twice Daily Total
Hide Arm/Group Description Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily Total of all reporting groups
Overall Number of Baseline Participants 294 296 590
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 294 participants 296 participants 590 participants
40.2  (9.09) 40.7  (9.50) 40.5  (9.29)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 294 participants 296 participants 590 participants
Female
115
  39.1%
98
  33.1%
213
  36.1%
Male
179
  60.9%
198
  66.9%
377
  63.9%
Age (years) (categorical)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 294 participants 296 participants 590 participants
Age <= 30 35 35 70
30 < Age <= 45 180 169 349
45 < Age <= 55 64 72 136
55 < Age <= 65 14 18 32
Age > 65 1 2 3
Hepatitis B or C Co-infection Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 294 participants 296 participants 590 participants
Negative 267 255 522
Positive 25 37 62
Unknown 2 4 6
1.Primary Outcome
Title Virological Response at Week 48 (Number of Participants With Plasma Viral Load Less Than 50 Copies/mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm
Hide Description The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm.
Time Frame 48 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse.
Arm/Group Title DRV/Rtv 800/100 mg Once Daily DRV/Rtv 600/100 mg Twice Daily
Hide Arm/Group Description:
Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
Overall Number of Participants Analyzed 294 296
Measure Type: Number
Unit of Measure: Participants
212 210
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DRV/Rtv 800/100 mg Once Daily, DRV/Rtv 600/100 mg Twice Daily
Comments Assuming a response rate of 70% at 48 weeks for both treatment groups, 306 participants were required per treatment arm to establish noninferiority of darunavir (DRV)/ritonavir (rtv) once daily versus DRV/rtv twice daily with a maximum allowable difference of 12%, with a 1-sided significance level of 0.025 and 90% power.
Type of Statistical Test Non-Inferiority or Equivalence
Comments If at Week 48, the lower limit of the 95% two-sided confidence interval of the difference between DRV/rtv once daily and DRV/rtv twice daily exceeds -12%, non-inferiority of the DRV/rtv q.d. versus the DRV/rtv b.i.d. therapy was concluded.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments The model includes treatment as factor and baseline viral load (log10) as covariate.
Method of Estimation Estimation Parameter Difference in proportion of response
Estimated Value 0.0019
Confidence Interval (2-Sided) 95%
-0.054 to 0.092
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.037
Estimation Comments Difference in proportion of response DRV/rtv once daily minus DRV/rtv twice daily estimated from the logistic regression model.
2.Secondary Outcome
Title Virologic Response at Week 48 (Viral Load Less Than 400 Copies/mL)
Hide Description Number of participants with confirmed plasma viral load less than 400 copies/mL at Week 48.
Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse.
Arm/Group Title DRV/Rtv 800/100 mg Once Daily DRV/Rtv 600/100 mg Twice Daily
Hide Arm/Group Description:
Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
Overall Number of Participants Analyzed 294 296
Measure Type: Number
Unit of Measure: Participants
226 227
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DRV/Rtv 800/100 mg Once Daily, DRV/Rtv 600/100 mg Twice Daily
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments If at Week 48, the lower limit of this 95% 2-sided CI of the difference between DRV/rtv q.d. and DRV/rtv b.i.d. exceeded -12%, noninferiority of DRV/rtv q.d. and DRV/rtv b.i.d. could be concluded.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments A logistic regression model includes treatment as fixed factor and baseline plasma viral load as a covariate.
Method of Estimation Estimation Parameter Difference in proportion of response
Estimated Value 0.007
Confidence Interval (2-Sided) 95%
-0.060 to 0.075
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.034
Estimation Comments Difference in proportion of response between 2 treatment groups (DRV/rtv q.d. minus DRV/rtv b.i.d)
3.Secondary Outcome
Title Change in log10 Viral Load From Baseline at Week 48
Hide Description [Not Specified]
Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse.
Arm/Group Title DRV/Rtv 800/100 mg Once Daily DRV/Rtv 600/100 mg Twice Daily
Hide Arm/Group Description:
Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
Overall Number of Participants Analyzed 294 296
Median (Full Range)
Unit of Measure: log10 copies/mL
Log10 Viral Load at baseline
4.23
(1.73 to 6.43)
4.134
(1.69 to 5.98)
Log10 Viral Load change from baseline at Week 48
-2.11
(-4.7 to 2.0)
-2.13
(-4.2 to 2.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DRV/Rtv 800/100 mg Once Daily, DRV/Rtv 600/100 mg Twice Daily
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.977
Comments [Not Specified]
Method ANCOVA
Comments Including 1 factor for treatment, and including the covariate baseline log10 plasma viral load
Method of Estimation Estimation Parameter Difference between least square means
Estimated Value -0.003
Confidence Interval (2-Sided) 95%
-0.188 to 0.182
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.094
Estimation Comments Difference between least square means between the DRV/rtv q.d. and DRV/rtv b.i.d. treatment groups at Week 48.
4.Secondary Outcome
Title Time to Reach First Virologic Response
Hide Description Time (in weeks) to achieve viral load less than 50 copies/mL by the participants.
Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse.
Arm/Group Title DRV/Rtv 800/100 mg Once Daily DRV/Rtv 600/100 mg Twice Daily
Hide Arm/Group Description:
Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
Overall Number of Participants Analyzed 294 296
Median (Full Range)
Unit of Measure: Days
85
(71 to 86)
85
(83 to 85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DRV/Rtv 800/100 mg Once Daily, DRV/Rtv 600/100 mg Twice Daily
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.917
Comments [Not Specified]
Method Cox proportional hazards
Comments Including treatment as fixed factor and baseline plasma viral load as a covariate
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.990
Confidence Interval (2-Sided) 95%
0.824 to 1.191
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.094
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Time to Loss of Virologic Response
Hide Description Time taken to lose the virologic response ie, plasma viral load less than 50 copies/mL by participants.
Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse.
Arm/Group Title DRV/Rtv 800/100 mg Once Daily DRV/Rtv 600/100 mg Twice Daily
Hide Arm/Group Description:
Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
Overall Number of Participants Analyzed 294 296
Mean (Standard Error)
Unit of Measure: Days
250.235  (6.598) 281.743  (7.47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DRV/Rtv 800/100 mg Once Daily, DRV/Rtv 600/100 mg Twice Daily
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.716
Comments [Not Specified]
Method Regression, Cox
Comments Including baseline log10 viral load as covariate
Method of Estimation Estimation Parameter Hazard Ratio, log
Estimated Value 0.945
Confidence Interval (2-Sided) 95%
0.699 to 1.279
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.154
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Time-averaged Difference (DAVG) of log10 Plasma Viral Load Over 48 Weeks
Hide Description [Not Specified]
Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention To Treat (ITT) population: Observed cases
Arm/Group Title DRV/Rtv 800/100 mg Once Daily DRV/Rtv 600/100 mg Twice Daily
Hide Arm/Group Description:
Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
Overall Number of Participants Analyzed 294 296
Least Squares Mean (Standard Error)
Unit of Measure: log10 copies/mL
-1.77  (0.051) -1.74  (0.051)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DRV/Rtv 800/100 mg Once Daily, DRV/Rtv 600/100 mg Twice Daily
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.711
Comments [Not Specified]
Method ANCOVA
Comments Including 1 factor for treatment, and including the covariate baseline log10 plasma viral load
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value -0.03
Confidence Interval (2-Sided) 95%
-0.169 to 0.115
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.072
Estimation Comments Difference in least square means between the 2 treatment groups (DRV/rtv q.d. and DRV/rtv b.i.d)
7.Secondary Outcome
Title Change in CD4+ Cell Count From Baseline
Hide Description CD4+ cell count was calculated using the Last Observation Carried Forward (LOCF) algorithm.
Time Frame 48 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention To Treat (ITT) population - last observation carried forward (LOCF): Intermittent missing values and missing values due to premature discontinuation were imputed with the last observation.
Arm/Group Title DRV/Rtv 800/100 mg Once Daily DRV/Rtv 600/100 mg Twice Daily
Hide Arm/Group Description:
Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
Overall Number of Participants Analyzed 294 296
Median (Full Range)
Unit of Measure: 10e6/l
Value at Baseline
219
(24 to 1306)
236
(44 to 864)
CD4+ cell count change from baseline at Week 48
100
(-242 to 808)
94
(-239 to 639)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DRV/Rtv 800/100 mg Once Daily, DRV/Rtv 600/100 mg Twice Daily
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.562
Comments [Not Specified]
Method ANCOVA
Comments The model includes treatment as factor and baseline CD4 count and baseline viral load (log10) as covariates.
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value -5.95
Confidence Interval (2-Sided) 95%
-26.09 to 14.20
Parameter Dispersion
Type: Standard Error of the mean
Value: 10.26
Estimation Comments Difference in least square means DRV/rtv once daily minus DRV/rtv twice daily estimated from the ANCOVA model.
8.Secondary Outcome
Title Change From Baseline in Total Functional Assessment of HIV Infection (FAHI) Score
Hide Description The FAHI is a 44-item questionnaire and incorporates 5 functional scales (physical well-being, emotional well-being/living with HIV, functional and global well-being, social well-being, and cognitive functioning). Each scale included several questions (all 5 scales include total 44 questions). For each question, participants gave a score of either 0 (not at all), 1 (a little bit), 2 (somewhat), 3 (quite a bit) and 4 (very much). Total FAHI imputed score is calculated by adding scores for each question. The range of total FAHI score is 0 to 176. Higher scores indicate worsening.
Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention To Treat (ITT) population - last observation carried forward (LOCF): Intermittent missing values and missing values due to premature discontinuation were imputed with the last observation.
Arm/Group Title DRV/Rtv 800/100 mg Once Daily DRV/Rtv 600/100 mg Twice Daily
Hide Arm/Group Description:
Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
Overall Number of Participants Analyzed 294 296
Median (Full Range)
Unit of Measure: Scores on a scale
FAHI score at baseline
129
(31 to 175)
123.5
(33 to 174)
Change from baseline in FAHI score at Week 48
2.5
(-74 to 81)
0.0
(-75 to 81)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DRV/Rtv 800/100 mg Once Daily, DRV/Rtv 600/100 mg Twice Daily
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.761
Comments [Not Specified]
Method ANCOVA
Comments Including factors for treatment, and baseline log10 plasma viral load and baseline FAHI score as covariates
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value 0.55
Confidence Interval (2-Sided) 95%
-2.97 to 4.06
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.79
Estimation Comments Difference in least square means DRV/rtv once daily minus DRV/rtv twice daily estimated from the ANCOVA model.
9.Secondary Outcome
Title Percentage of Participants Adherent/Non-adherent to ARV as Determined by Modified Medication Adherence Self Report Inventory (M-MASRI) Questionnaire at Week 48
Hide Description Self-reported adherence to the ARV medications was measured. The M-MASRI asks participants to report the number of doses taken, as well as the number of doses taken during the last 30 days prior to the study visit by means of a horizontal visual analogue scale (VAS) that generates a self-rated percentage of doses of all the ARV medications taken during the past 30 days.
Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication.
Arm/Group Title DRV/Rtv 800/100 mg Once Daily DRV/Rtv 600/100 mg Twice Daily
Hide Arm/Group Description:
Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
Overall Number of Participants Analyzed 294 296
Measure Type: Number
Unit of Measure: Percentage of participants
Adherent 67.4 60.3
Non-adherent 32.6 39.7
10.Secondary Outcome
Title Area Under the Curve From the Time of Study Medication Administration Upto 24 Hour Postdose (AUC24h) of DRV and Rtv
Hide Description Pharmacokinetic parameter AUC24h was assessed from the time of study medication administration upto 24 hour postdose. Population Pharmacokinetic Estimates of DRV and rtv were evaluated.
Time Frame 0 hour predose and 1 hour post dose measured at Weeks 4 and 24. Any time point measured at Weeks 8 and 48.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication.
Arm/Group Title DRV/Rtv 800/100 mg Once Daily DRV/Rtv 600/100 mg Twice Daily
Hide Arm/Group Description:
Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
Overall Number of Participants Analyzed 294 296
Median (Full Range)
Unit of Measure: ng*h/mL
Population Pharmacokinetic Estimates of DRV
87788
(45456 to 236920)
109401
(48934 to 323820)
Population Pharmacokinetic Estimates of rtv
5776
(1801 to 39027)
12588
(3404 to 44762)
11.Secondary Outcome
Title Predose Plasma Concentration (C0h) of DRV and Rtv.
Hide Description Pharmacokinetic parameter C0h was assessed. Population Pharmacokinetic Estimates of DRV and rtv were evaluated.
Time Frame 0 hour predose and 1 hour post dose measured at Weeks 4 and 24. Any time point measured at Weeks 8 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication.
Arm/Group Title DRV/Rtv 800/100 mg Once Daily DRV/Rtv 600/100 mg Twice Daily
Hide Arm/Group Description:
Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
Overall Number of Participants Analyzed 294 296
Median (Full Range)
Unit of Measure: ng/mL
Population Pharmacokinetic Estimates of DRV
1896
(184 to 7881)
3197
(250 to 11865)
Population Pharmacokinetic Estimates of rtv
59
(6 to 1049)
307
(41 to 1657)
12.Secondary Outcome
Title Number of Participants Developing Mutations at Endpoint
Hide Description Development of Mutations in Virologic Failures (Plasma Viral Load less than 50 Copies/mL) at endpoint.
Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication.
Arm/Group Title DRV/Rtv 800/100 mg Once Daily DRV/Rtv 600/100 mg Twice Daily
Hide Arm/Group Description:
Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
Overall Number of Participants Analyzed 294 296
Measure Type: Number
Unit of Measure: Participants
DRV resistance-associated mutation (RAM) 1 0
Primary (major) protease inhibitor (PI) mutations 1 0
Protease inhibitor (PI) RAMs 7 4
Nucleoside reverse transcriptase inhibitor RAMs 4 3
Time Frame 52 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DRV/Rtv 800/100 mg Once Daily DRV/Rtv 600/100 mg Twice Daily
Hide Arm/Group Description Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
All-Cause Mortality
DRV/Rtv 800/100 mg Once Daily DRV/Rtv 600/100 mg Twice Daily
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
DRV/Rtv 800/100 mg Once Daily DRV/Rtv 600/100 mg Twice Daily
Affected / at Risk (%) Affected / at Risk (%)
Total   16/294 (5.44%)   27/296 (9.12%) 
Blood and lymphatic system disorders     
Anaemia * 1  0/294 (0.00%)  2/296 (0.68%) 
Bicytopenia * 1  0/294 (0.00%)  1/296 (0.34%) 
Lymphadenopathy * 1  1/294 (0.34%)  0/296 (0.00%) 
Cardiac disorders     
Cardiac failure congestive * 1  0/294 (0.00%)  2/296 (0.68%) 
Atrioventricular block first degree * 1  0/294 (0.00%)  1/296 (0.34%) 
Sinus bradycardia * 1  0/294 (0.00%)  1/296 (0.34%) 
Cardio-respiratory arrest * 1  1/294 (0.34%)  0/296 (0.00%) 
Eye disorders     
Retinal detachment * 1  1/294 (0.34%)  0/296 (0.00%) 
Gastrointestinal disorders     
Abdominal pain * 1  0/294 (0.00%)  1/296 (0.34%) 
Vomiting * 1  0/294 (0.00%)  1/296 (0.34%) 
General disorders     
Drug interaction * 1  0/294 (0.00%)  1/296 (0.34%) 
Pyrexia * 1  1/294 (0.34%)  0/296 (0.00%) 
Hepatobiliary disorders     
Bile duct obstruction * 1  0/294 (0.00%)  1/296 (0.34%) 
Hepatitis * 1  0/294 (0.00%)  1/296 (0.34%) 
Infections and infestations     
Pneumonia * 1  3/294 (1.02%)  3/296 (1.01%) 
Dermo-hypodermitis * 1  0/294 (0.00%)  1/296 (0.34%) 
Escherichia urinary tract infection * 1  0/294 (0.00%)  1/296 (0.34%) 
Gastroenteritis cryptosporidial * 1  0/294 (0.00%)  1/296 (0.34%) 
Lung infection * 1  0/294 (0.00%)  1/296 (0.34%) 
Mastoiditis * 1  0/294 (0.00%)  1/296 (0.34%) 
Peritonitis bacterial * 1  0/294 (0.00%)  1/296 (0.34%) 
Sepsis * 1  0/294 (0.00%)  1/296 (0.34%) 
Toxoplasmosis * 1  0/294 (0.00%)  1/296 (0.34%) 
Appendicitis * 1  1/294 (0.34%)  0/296 (0.00%) 
Bronchopneumonia * 1  1/294 (0.34%)  0/296 (0.00%) 
Extrapulmonary tuberculosis * 1  1/294 (0.34%)  0/296 (0.00%) 
Infected cyst * 1  1/294 (0.34%)  0/296 (0.00%) 
Influenza * 1  1/294 (0.34%)  0/296 (0.00%) 
Lobar pneumonia * 1  1/294 (0.34%)  0/296 (0.00%) 
Malaria * 1  1/294 (0.34%)  0/296 (0.00%) 
Injury, poisoning and procedural complications     
Alcohol poisoning * 1  0/294 (0.00%)  1/296 (0.34%) 
Concussion * 1  0/294 (0.00%)  1/296 (0.34%) 
Drug toxicity * 1  0/294 (0.00%)  1/296 (0.34%) 
Skin laceration * 1  0/294 (0.00%)  1/296 (0.34%) 
Whiplash injury * 1  0/294 (0.00%)  1/296 (0.34%) 
Overdose * 1  1/294 (0.34%)  0/296 (0.00%) 
Post procedural bile leak * 1  1/294 (0.34%)  0/296 (0.00%) 
Investigations     
Weight decreased * 1  0/294 (0.00%)  1/296 (0.34%) 
Metabolism and nutrition disorders     
Diabetic ketoacidosis * 1  0/294 (0.00%)  1/296 (0.34%) 
Hyperamylasaemia * 1  0/294 (0.00%)  1/296 (0.34%) 
Hypercholesterolaemia * 1  0/294 (0.00%)  1/296 (0.34%) 
Lactic acidosis * 1  0/294 (0.00%)  1/296 (0.34%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lymphoma * 1  0/294 (0.00%)  1/296 (0.34%) 
Uterine cancer * 1  0/294 (0.00%)  1/296 (0.34%) 
Nervous system disorders     
Carpal tunnel syndrome * 1  0/294 (0.00%)  1/296 (0.34%) 
Carotid artery aneurysm * 1  1/294 (0.34%)  0/296 (0.00%) 
Psychiatric disorders     
Anxiety * 1  0/294 (0.00%)  2/296 (0.68%) 
Abnormal behaviour * 1  0/294 (0.00%)  1/296 (0.34%) 
Suicidal ideation * 1  1/294 (0.34%)  0/296 (0.00%) 
Suicide attempt * 1  1/294 (0.34%)  0/296 (0.00%) 
Renal and urinary disorders     
Calculus ureteric * 1  0/294 (0.00%)  1/296 (0.34%) 
Nephrolithiasis * 1  0/294 (0.00%)  1/296 (0.34%) 
Renal failure acute * 1  0/294 (0.00%)  1/296 (0.34%) 
Reproductive system and breast disorders     
Vulval ulceration * 1  1/294 (0.34%)  0/296 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory distress * 1  0/294 (0.00%)  2/296 (0.68%) 
Asthma * 1  0/294 (0.00%)  1/296 (0.34%) 
Pharyngolaryngeal pain * 1  0/294 (0.00%)  1/296 (0.34%) 
Pulmonary bulla * 1  0/294 (0.00%)  1/296 (0.34%) 
Hypoventilation * 1  1/294 (0.34%)  0/296 (0.00%) 
Interstitial lung disease * 1  1/294 (0.34%)  0/296 (0.00%) 
Pulmonary embolism * 1  1/294 (0.34%)  0/296 (0.00%) 
Skin and subcutaneous tissue disorders     
Angiodermatitis * 1  0/294 (0.00%)  1/296 (0.34%) 
Surgical and medical procedures     
Intervertebral disc operation * 1  1/294 (0.34%)  0/296 (0.00%) 
Vascular disorders     
Deep vein thrombosis * 1  1/294 (0.34%)  0/296 (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%
DRV/Rtv 800/100 mg Once Daily DRV/Rtv 600/100 mg Twice Daily
Affected / at Risk (%) Affected / at Risk (%)
Total   134/294 (45.58%)   147/296 (49.66%) 
Gastrointestinal disorders     
Diarrhoea * 1  42/294 (14.29%)  66/296 (22.30%) 
Nausea * 1  38/294 (12.93%)  42/296 (14.19%) 
Vomiting * 1  13/294 (4.42%)  25/296 (8.45%) 
Infections and infestations     
Nasopharyngitis * 1  19/294 (6.46%)  19/296 (6.42%) 
Influenza * 1  17/294 (5.78%)  18/296 (6.08%) 
Upper respiratory tract infection * 1  17/294 (5.78%)  18/296 (6.08%) 
Bronchitis * 1  16/294 (5.44%)  11/296 (3.72%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  16/294 (5.44%)  11/296 (3.72%) 
Nervous system disorders     
Headache * 1  20/294 (6.80%)  20/296 (6.76%) 
Skin and subcutaneous tissue disorders     
Rash * 1  15/294 (5.10%)  14/296 (4.73%) 
*
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.
The Sponsor will not unreasonably withhold consent to publish the data generated in this trial. However, it is the policy of the Sponsor not to allow the investigators to publish their results or findings prior to the Sponsor’s publication of the overall trial results. The investigator agrees that before he/she publishes any results of this trial, he/she shall allow at least 45 days for the Sponsor to review the prepublication manuscript prior to submission of the manuscript to the publisher.
Results Point of Contact
Name/Title: Medical Leader
Organization: Tibotec Pharmaceuticals, Ireland
Phone: +32 015 461 497
Responsible Party: Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier: NCT00524368     History of Changes
Obsolete Identifiers: NCT00613990
Other Study ID Numbers: CR013783
TMC114-TiDP31-C229 ( Other Identifier: Tibotec Pharmaceuticals, Ireland )
2007-001939-61 ( EudraCT Number )
First Submitted: August 30, 2007
First Posted: September 3, 2007
Results First Submitted: August 27, 2010
Results First Posted: September 22, 2010
Last Update Posted: February 15, 2013