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A Clinical Trial Comparing the Efficacy of Darunavir/Ritonavir Monotherapy Versus a Triple Combination Therapy Containing Darunavir/Ritonavir and 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Patients With Undetectable Plasma HIV-1 RNA on Current Treatment (PROTEA)

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ClinicalTrials.gov Identifier: NCT01448707
Recruitment Status : Completed
First Posted : October 7, 2011
Results First Posted : December 3, 2015
Last Update Posted : November 27, 2017
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag International NV

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Human Immunodeficiency Virus (HIV) Infections
Acquired Immunodeficiency Syndrome (AIDS) Virus
Interventions Drug: Darunavir
Drug: Ritonavir
Enrollment 274
Recruitment Details  
Pre-assignment Details 325 participants screened, among them 282 were eligible for run-in phase and among them 274 enrolled to the study. 1 randomized participant was not treated (274 participants were randomized).
Arm/Group Title DRV/Rtv MONO DRV/Rtv + 2NRTIs
Hide Arm/Group Description Darunavir (DRV) and ritonavir (rtv): 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal. Darunavir (DRV), ritonavir (rtv) and 2 N[t]RTIs: 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC).
Period Title: Overall Study
Started 137 136
Completed 119 118
Not Completed 18 18
Reason Not Completed
Adverse Event             3             1
Lost to Follow-up             2             6
Withdrawal by Subject             6             7
Other             7             4
Arm/Group Title DRV/Rtv MONO DRV/Rtv + 2NRTIs Total
Hide Arm/Group Description Darunavir (DRV) and ritonavir (rtv): 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal. Darunavir (DRV), ritonavir (rtv) and 2 N[t]RTIs: 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC). Total of all reporting groups
Overall Number of Baseline Participants 137 136 273
Hide Baseline Analysis Population Description
Baseline characteristics were analyzed for all participants who were treated.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 137 participants 136 participants 273 participants
44.6  (11.21) 43.1  (10.41) 43.9  (10.82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 137 participants 136 participants 273 participants
Female
26
  19.0%
21
  15.4%
47
  17.2%
Male
111
  81.0%
115
  84.6%
226
  82.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 137 participants 136 participants 273 participants
AUSTRIA 5 5 10
BELGIUM 7 8 15
DENMARK 8 7 15
FRANCE 16 12 28
GERMANY 11 11 22
HUNGARY 5 3 8
IRELAND 3 5 8
ISRAEL 5 5 10
ITALY 22 24 46
POLAND 7 6 13
SPAIN 17 23 40
SWEDEN 3 4 7
SWITZERLAND 10 5 15
UNITED KINGDOM 18 18 36
1.Primary Outcome
Title Virologic Response (Food Drug and Administration [FDA] Snapshot, Switch = Failure)
Hide Description The percentage of participants who have plasma human immunodeficiency virus type-1 (HIV-1) ribonucleic acid (RNA) levels <50 copies/milliliters [mL] after 48 weeks of follow-up. Switch = Failure is defined as switch in background nucleoside/nucleotide reverse transcriptase inhibitors (N[t]RTIs) not permitted by the trial protocol or plasma HIV-1 RNA assessment closest to target date of the analysis time point window (44-52 weeks) and next/confirmation of Plasma HIV-1 RNA in the analysis time point window above the threshold or discontinuation for any other reason.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.
Arm/Group Title DRV/r DRV/r + 2NRTIs
Hide Arm/Group Description:
Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
Darunavir (DRV) + ritonavir (rtv) + 2 N[t]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
Overall Number of Participants Analyzed 137 136
Measure Type: Number
Unit of Measure: Percentage of Participants
87.0 95.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DRV/r, DRV/r + 2NRTIs
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority of DRV/rtv monotherapy versus triple therapy was assessed with a maximum allowable difference of 12 percent (%), with a one-sided significance level of 2.5%.
Statistical Test of Hypothesis P-Value 0.2331
Comments P-Value for non-inferiority of DRV/rtv MONO vs DRV/rtv + 2NRTIs (delta = 12%).
Method Mixed Models Analysis
Comments Predicted response rate:confidence limits are obtained by means of logistic regression model with treatment group and Hepatitis C status as covariates
Method of Estimation Estimation Parameter Non-Linear mixed
Estimated Value -7.9
Confidence Interval (2-Sided) 95%
-14.64 to -1.19
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Virologic Response (Food Drug and Administration [FDA] Snapshot, Switch = Failure)
Hide Description The percentage of participants who have plasma human immunodeficiency virus type-1 (HIV-1) ribonucleic acid (RNA) levels <50 copies/milliliters [mL] after 96 weeks of follow-up after switching to DRV/ritonavir(rtv) monotherapy versus triple therapy containing DRV/rtv. Switch = Failure is defined as switch in background nucleoside/nucleotide reverse transcriptase inhibitors (N[t]RTIs) not permitted by the trial protocol.
Time Frame Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.
Arm/Group Title DRV/r DRV/r + 2NRTIs
Hide Arm/Group Description:
Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
Darunavir (DRV) + ritonavir (rtv) + 2 N[t]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
Overall Number of Participants Analyzed 137 136
Measure Type: Number
Unit of Measure: Percentage of Participants
75.2 85.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DRV/r, DRV/r + 2NRTIs
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority of DRV/rtv monotherapy versus triple therapy was assessed with a maximum allowable difference of 12 percent (%), with a one-sided significance level of 2.5% and 80% power.
Statistical Test of Hypothesis P-Value 0.6933
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Non-Linear mixed
Estimated Value -10.1
Confidence Interval (2-Sided) 95%
-19.50 to -0.73
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Virologic Response (FDA Snapshot, Switch Included)
Hide Description The percentage of participants who have plasma human immunodeficiency virus type-1 (HIV-1) ribonucleic acid (RNA) levels <50 copies/milliliters [mL] after 48 and 96 weeks of follow-up after switching to DRV/ritonavir(rtv) monotherapy versus triple therapy containing DRV/rtv. Switch included is defined as all participants who discontinued randomized medication were followed up on their subsequent treatment.
Time Frame Week 48 and 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.
Arm/Group Title DRV/r DRV/r + 2NRTIs
Hide Arm/Group Description:
Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
Darunavir (DRV) + ritonavir (rtv) + 2 N[t]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
Overall Number of Participants Analyzed 137 136
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 48 93.0 96.5
Week 96 89.3 89.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DRV/r, DRV/r + 2NRTIs
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Week 48: Non-inferiority of DRV/rtv monotherapy versus triple therapy was assessed with a maximum allowable difference of 12 percent (%), with a one-sided significance level of 2.5% and 80% power.
Statistical Test of Hypothesis P-Value 0.0016
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Non-linear mixed model
Estimated Value -3.5
Confidence Interval (2-Sided) 95%
-8.77 to 1.72
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DRV/r, DRV/r + 2NRTIs
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Week 96: Non-inferiority of DRV/rtv monotherapy versus triple therapy was assessed with a maximum allowable difference of 12 percent (%), with a one-sided significance level of 2.5% and 80% power.
Statistical Test of Hypothesis P-Value 0.0022
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter non-linear mixed model
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-7.89 to 6.58
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Global Neurocognitive Performance z-Score
Hide Description Change in neurocognitive function of DRV/rtv monotherapy versus triple therapy containing DRV/rtv over 48 and 96 weeks. Neurocognitive function will be measured by Hopkins Verbal Learning Test (verbal learning and memory), Colour Trail Test (psychomotor speed and cognitive flexibility) and Grooved Pegboard Test (psychomotor speed and fine motor function). Higher values for change in z-score represent an improvement in Neurocognitive Performance (NP).
Time Frame Baseline, Week 48 and 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.
Arm/Group Title DRV/r DRV/r + 2NRTIs
Hide Arm/Group Description:
Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
Darunavir (DRV) + ritonavir (rtv) + 2 N[t]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
Overall Number of Participants Analyzed 137 136
Mean (Standard Error)
Unit of Measure: Units on a Scale
Change at Week 48 0.39  (0.048) 0.42  (0.057)
Change at Week 96 0.63  (0.060) 0.57  (0.057)
5.Secondary Outcome
Title Time to Loss of Virologic Response
Hide Description Time (in days) it takes to show loss of response per time to loss of virologic response (TLOVR) algorithm: confirmed HIV-1 RNA >= 50 copies/mL or premature discontinuation.
Time Frame Baseline up to Week 96 or early withdrawal
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.
Arm/Group Title DRV/r DRV/r + 2NRTIs
Hide Arm/Group Description:
Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
Darunavir (DRV) + ritonavir (rtv) + 2 N[t]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
Overall Number of Participants Analyzed 137 136
Median (Full Range)
Unit of Measure: Days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
The event occurred in less than 50 percent of the participants.
6.Secondary Outcome
Title Number of Participants Reporting Treatment-Emergent Phenotypic Drug Resistance
Hide Description The loss of treatment options of DRV/rtv monotherapy versus triple therapy containing DRV/rtv at Weeks 48 and 96, as defined by treatment-emergent phenotypic drug resistance. Drug resistance is classified as: 1) Confirmed HIV RNA >= 400 copies/mL, 2) Post-baseline phenotypic data and 3) Phenotypic resistance to any of the drug classes (NRTI, NNRTI, or PI).
Time Frame At Weeks 48 and 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.
Arm/Group Title DRV/r DRV/r + 2NRTIs
Hide Arm/Group Description:
Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
Darunavir (DRV) + ritonavir (rtv) + 2 N[t]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
Overall Number of Participants Analyzed 137 136
Measure Type: Number
Unit of Measure: Participants
Confirmed HIV RNA >= 400 copies/mL 1 2
Post-baseline phenotypic data 2 1
Phenotypic resistance to any of the drug classes 0 0
7.Secondary Outcome
Title Number of Participants Reporting Resistance Mutations With Confirmed Virologic Failure Who Have HIV RNA >400 Copies/mL and Genotype Resistance Results
Hide Description The viral genotype of participants treated with DRV/rtv monotherapy versus triple therapy containing DRV/rtv over 48 and 96 weeks. Genotypic resistance (number of resistance mutations) at any time point when a participant had a confirmed plasma VL >400 copies/mL after randomization was performed per treatment group for the ITT population. Results were summarized based on individual treatment received: Darunavir resistance mutations, non-nucleoside reverse transcriptase inhibitor (NNRTI) mutations, nucleoside reverse transcriptase inhibitor (NRTI) mutations, protease inhibitor (PI) resistance mutations, PR mutations, RT mutations, extended NNRTI mutations, primary PI mutations.
Time Frame Over 48 and 96 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.
Arm/Group Title DRV/r DRV/r + 2NRTIs
Hide Arm/Group Description:
Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
Darunavir (DRV) + ritonavir (rtv) + 2 N[t]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
Overall Number of Participants Analyzed 137 136
Measure Type: Number
Unit of Measure: Participants
Participans with HIV RNA >= 400 copies/mL 1 2
Number of 0 Darunavir resistance mutations 2 1
Number of 0 NNRTI mutations 2 0
Number of 1 NNRTI mutations 0 1
Number of 1 PI resistance mutations 1 0
Number of 5 PI resistance mutations 0 1
Number of 6 PI resistance mutations 1 0
Number of 11 PR mutations 0 1
Number of 15 PR mutations 1 0
Number of 7 PR mutations 1 0
Number of 14 RT mutations 1 0
Number of 16 RT mutations 0 1
Number of 33 RT mutations 1 0
Number of extended 0 NNRTI mutations 2 0
Number of extended 1 NNRTI mutations 0 1
Number of primary 0 PI mutations 2 1
Number of participants with no mutations 0 0
Time Frame Baseline up to 96 weeks
Adverse Event Reporting Description The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
 
Arm/Group Title DRV/Rtv MONO DRV/Rtv + 2NRTIs
Hide Arm/Group Description Darunavir (DRV) and ritonavir (rtv): 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal. Darunavir (DRV), ritonavir (rtv) and 2 N[t]RTIs: 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC).
All-Cause Mortality
DRV/Rtv MONO DRV/Rtv + 2NRTIs
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
DRV/Rtv MONO DRV/Rtv + 2NRTIs
Affected / at Risk (%) Affected / at Risk (%)
Total   18/137 (13.14%)   14/136 (10.29%) 
Blood and lymphatic system disorders     
Anaemia * 1  1/137 (0.73%)  0/136 (0.00%) 
Lymphadenopathy * 1  1/137 (0.73%)  0/136 (0.00%) 
Cardiac disorders     
Cardiac Arrest * 1  1/137 (0.73%)  0/136 (0.00%) 
Gastrointestinal disorders     
Anal Fistula * 1  1/137 (0.73%)  0/136 (0.00%) 
General disorders     
Pyrexia * 1  1/137 (0.73%)  1/136 (0.74%) 
Tenderness * 1  0/137 (0.00%)  1/136 (0.74%) 
Immune system disorders     
Hypersensitivity * 1  0/137 (0.00%)  1/136 (0.74%) 
Infections and infestations     
Abscess * 1  0/137 (0.00%)  1/136 (0.74%) 
Cellulitis * 1  0/137 (0.00%)  1/136 (0.74%) 
Cytomegalovirus Infection * 1  1/137 (0.73%)  0/136 (0.00%) 
Gastroenteritis Viral * 1  0/137 (0.00%)  1/136 (0.74%) 
Groin Abscess * 1  0/137 (0.00%)  1/136 (0.74%) 
Hepatitis B * 1  1/137 (0.73%)  0/136 (0.00%) 
Hepatitis C * 1  2/137 (1.46%)  0/136 (0.00%) 
Meningitis * 1  0/137 (0.00%)  1/136 (0.74%) 
Pharyngitis Bacterial * 1  1/137 (0.73%)  0/136 (0.00%) 
Pyelonephritis * 1  0/137 (0.00%)  1/136 (0.74%) 
Sepsis * 1  0/137 (0.00%)  1/136 (0.74%) 
Shigella Infection * 1  1/137 (0.73%)  0/136 (0.00%) 
Injury, poisoning and procedural complications     
Facial Bones Fracture * 1  1/137 (0.73%)  0/136 (0.00%) 
Laceration * 1  1/137 (0.73%)  0/136 (0.00%) 
Laryngeal Injury * 1  0/137 (0.00%)  1/136 (0.74%) 
Lumbar Vertebral Fracture * 1  0/137 (0.00%)  1/136 (0.74%) 
Post Lumbar Puncture Syndrome * 1  0/137 (0.00%)  1/136 (0.74%) 
Radius Fracture * 1  1/137 (0.73%)  0/136 (0.00%) 
Metabolism and nutrition disorders     
Hyperkalaemia * 1  1/137 (0.73%)  0/136 (0.00%) 
Musculoskeletal and connective tissue disorders     
Rhabdomyolysis * 1  0/137 (0.00%)  1/136 (0.74%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Anogenital Warts * 1  1/137 (0.73%)  0/136 (0.00%) 
Bowen's Disease * 1  1/137 (0.73%)  0/136 (0.00%) 
Breast Cancer * 1  1/137 (0.73%)  0/136 (0.00%) 
Diffuse Large B-Cell Lymphoma * 1  0/137 (0.00%)  1/136 (0.74%) 
Nervous system disorders     
Central Nervous System Lesion * 1  0/137 (0.00%)  1/136 (0.74%) 
Encephalomyelitis * 1  1/137 (0.73%)  0/136 (0.00%) 
Headache * 1  0/137 (0.00%)  1/136 (0.74%) 
Ischaemic Stroke * 1  1/137 (0.73%)  0/136 (0.00%) 
Lethargy * 1  0/137 (0.00%)  1/136 (0.74%) 
Optic Neuritis * 1  0/137 (0.00%)  1/136 (0.74%) 
Pregnancy, puerperium and perinatal conditions     
Abortion Spontaneous * 1  0/137 (0.00%)  1/136 (0.74%) 
Psychiatric disorders     
Alcoholism * 1  1/137 (0.73%)  0/136 (0.00%) 
Substance Abuse * 1  0/137 (0.00%)  1/136 (0.74%) 
Renal and urinary disorders     
Calculus Urinary * 1  1/137 (0.73%)  0/136 (0.00%) 
Renal Failure * 1  0/137 (0.00%)  1/136 (0.74%) 
Urinary Retention * 1  0/137 (0.00%)  1/136 (0.74%) 
Respiratory, thoracic and mediastinal disorders     
Nasal Obstruction * 1  1/137 (0.73%)  0/136 (0.00%) 
Skin and subcutaneous tissue disorders     
Excessive Granulation Tissue * 1  0/137 (0.00%)  1/136 (0.74%) 
Rash * 1  0/137 (0.00%)  1/136 (0.74%) 
Rash Pruritic * 1  1/137 (0.73%)  0/136 (0.00%) 
Skin Ulcer * 1  0/137 (0.00%)  1/136 (0.74%) 
Surgical and medical procedures     
Gastrectomy * 1  0/137 (0.00%)  1/136 (0.74%) 
Tonsillectomy * 1  0/137 (0.00%)  1/136 (0.74%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
DRV/Rtv MONO DRV/Rtv + 2NRTIs
Affected / at Risk (%) Affected / at Risk (%)
Total   61/137 (44.53%)   47/136 (34.56%) 
Gastrointestinal disorders     
Diarrhoea * 1  18/137 (13.14%)  10/136 (7.35%) 
General disorders     
Fatigue * 1  7/137 (5.11%)  7/136 (5.15%) 
Pyrexia * 1  4/137 (2.92%)  7/136 (5.15%) 
Infections and infestations     
Nasopharyngitis * 1  16/137 (11.68%)  11/136 (8.09%) 
Metabolism and nutrition disorders     
Hypercholesterolaemia * 1  7/137 (5.11%)  0/136 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  7/137 (5.11%)  7/136 (5.15%) 
Back Pain * 1  10/137 (7.30%)  4/136 (2.94%) 
Nervous system disorders     
Headache * 1  8/137 (5.84%)  9/136 (6.62%) 
Psychiatric disorders     
Depression * 1  4/137 (2.92%)  7/136 (5.15%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  8/137 (5.84%)  8/136 (5.88%) 
Skin and subcutaneous tissue disorders     
Rash * 1  7/137 (5.11%)  3/136 (2.21%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 15.0
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.
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days. The sponsor will not mandate modifications to scientific content and does not have the right to suppress information.
Results Point of Contact
Name/Title: EMEA Medical Affairs Program Lead
Organization: Janssen Research & Development, LLC
Responsible Party: Janssen-Cilag International NV
ClinicalTrials.gov Identifier: NCT01448707     History of Changes
Other Study ID Numbers: CR018370
TMC114IFD3003 ( Other Identifier: Janssen )
2011-001635-23 ( EudraCT Number )
PROTEA ( Other Identifier: Janssen )
First Submitted: June 2, 2011
First Posted: October 7, 2011
Results First Submitted: October 30, 2015
Results First Posted: December 3, 2015
Last Update Posted: November 27, 2017