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Treatment Simplification by Darunavir/Ritonavir 800/100 mg Once a Day Versus a Triple Combination Therapy With Darunavir/Ritonavir (MONET)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag International NV
ClinicalTrials.gov Identifier:
NCT00458302
First received: April 6, 2007
Last updated: December 14, 2012
Last verified: December 2012
Results First Received: February 4, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: HIV Infections
AIDS Virus
Human Immunodeficiency Virus
Acquired Immunodeficiency Syndrome Virus
Intervention: Drug: darunavir (DRV, TMC114)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
xxxxx

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
DRV/r+2NRTIs 800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
DRV/r 800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks

Participant Flow:   Overall Study
    DRV/r+2NRTIs     DRV/r  
STARTED     129     127  
COMPLETED     109     103  
NOT COMPLETED     20     24  
Adverse Event                 4                 14  
Pregnancy                 2                 1  
Protocol Violation                 0                 2  
Withdrawal by Subject                 6                 4  
Inc/Exc Criteria Not Met                 1                 1  
Study Termination By Sponsor                 1                 0  
Lost to Follow-up                 2                 0  
Unknown                 4                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
DRV/r+2NRTIs 800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
DRV/r 800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
Total Total of all reporting groups

Baseline Measures
    DRV/r+2NRTIs     DRV/r     Total  
Number of Participants  
[units: participants]
  129     127     256  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     128     125     253  
>=65 years     1     2     3  
Age  
[units: years]
Mean ± Standard Deviation
  44.1  ± 9.74     43.4  ± 9.14     43.7  ± 9.43  
Gender  
[units: participants]
     
Female     22     28     50  
Male     107     99     206  
Region of Enrollment  
[units: participants]
     
AUSTRIA     9     7     16  
BELGIUM     12     12     24  
DENMARK     14     14     28  
GERMANY     14     14     28  
HUNGARY     6     5     11  
ISRAEL     1     7     8  
ITALY     11     5     16  
POLAND     9     20     29  
PORTUGAL     7     7     14  
RUSSIAN FEDERATION     9     2     11  
SPAIN     24     24     48  
SWITZERLAND     1     1     2  
UNITED KINGDOM     12     9     21  
plasma viral load [1]
[units: participants]
     
< 50     125     118     243  
50-400     4     7     11  
400-1000     0     0     0  
> 1000     0     2     2  
CD4+ cell count (absolute count)  
[units: cells/µl]
Median ( Full Range )
  579.0  
  ( 163 to 1888 )  
  571.0  
  ( 162 to 1451 )  
  573.5  
  ( 162 to 1888 )  
[1] plasma viral load (HIV-1 RNA copies/ml)



  Outcome Measures
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1.  Primary:   Virological Response [Per Protocol (PP) - Time to Loss of Virologic Response (TLOVR), < 50 Copies/ml, Week 48]   [ Time Frame: Week 48 ]

2.  Secondary:   Virological Response [Intent To Treat (ITT) - TLOVR, < 50 Copies/ml, Week 48]   [ Time Frame: Week 48 ]

3.  Secondary:   Virological Response [Per Protocol (PP), TLOVR - Switch Equals Failure, < 50 Copies/ml, Week 144]   [ Time Frame: Week 144 ]

4.  Secondary:   Virological Response [Intent To Treat (ITT), TLOVR - All Switches Included, < 50 Copies/ml, Week 144]   [ Time Frame: Week 144 ]

5.  Secondary:   Virological Response [Per Protocol (PP), TLOVR - Switch Equals Failure, <200 Copies/ml, Week 144]   [ Time Frame: week 144 ]

6.  Secondary:   Mean Change From Baseline in CD4+ Cell Count   [ Time Frame: at week 4, 12, 24, 36, 48, 60, 72, 84, 96, 112, 128, 144 ]

7.  Secondary:   Resistance Determinations   [ Time Frame: at each visit from baseline to week 144 ]

8.  Secondary:   Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Total Score   [ Time Frame: at baseline, week 48, 96 and 144 ]

9.  Secondary:   Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Cognitive Function Subscale   [ Time Frame: at baseline, week 48, 96 and 144 ]

10.  Secondary:   Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Emotional Well-Being Subscale   [ Time Frame: at baseline, week 48, 96 and 144 ]

11.  Secondary:   Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Functional and Global Well-Being Subscale   [ Time Frame: at baseline, week 48, 96 and 144 ]

12.  Secondary:   Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Physical Well-Being Subscale   [ Time Frame: at baseline, week 48, 96 and 144 ]

13.  Secondary:   Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Social Well-Being Subscale   [ Time Frame: at baseline, week 48, 96 and 144 ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group).
Additional Description Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
DRV/r+2NRTIs 800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
DRV/r 800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
Total No text entered.

Other Adverse Events
    DRV/r+2NRTIs     DRV/r     Total  
Total, other (not including serious) adverse events        
# participants affected / at risk     98/129     103/127     201/256  
Gastrointestinal disorders        
Diarrhoea * 1      
# participants affected / at risk     26/129 (20.16%)     26/127 (20.47%)     52/256 (20.31%)  
Vomiting * 1      
# participants affected / at risk     9/129 (6.98%)     1/127 (0.79%)     10/256 (3.91%)  
Nausea * 1      
# participants affected / at risk     7/129 (5.43%)     5/127 (3.94%)     12/256 (4.69%)  
General disorders        
Fatigue * 1      
# participants affected / at risk     6/129 (4.65%)     7/127 (5.51%)     13/256 (5.08%)  
Infections and infestations        
Bronchitis * 1      
# participants affected / at risk     12/129 (9.30%)     10/127 (7.87%)     22/256 (8.59%)  
Nasopharyngitis * 1      
# participants affected / at risk     10/129 (7.75%)     15/127 (11.81%)     25/256 (9.77%)  
Respiratory Tract Infection * 1      
# participants affected / at risk     9/129 (6.98%)     1/127 (0.79%)     10/256 (3.91%)  
Upper Respiratory Tract Infection * 1      
# participants affected / at risk     7/129 (5.43%)     12/127 (9.45%)     19/256 (7.42%)  
Investigations        
Blood Cholesterol Increased * 1      
# participants affected / at risk     2/129 (1.55%)     7/127 (5.51%)     9/256 (3.52%)  
Metabolism and nutrition disorders        
Hypercholesterolaemia * 1      
# participants affected / at risk     6/129 (4.65%)     19/127 (14.96%)     25/256 (9.77%)  
Musculoskeletal and connective tissue disorders        
Back Pain * 1      
# participants affected / at risk     4/129 (3.10%)     8/127 (6.30%)     12/256 (4.69%)  
Nervous system disorders        
Headache * 1      
# participants affected / at risk     10/129 (7.75%)     12/127 (9.45%)     22/256 (8.59%)  
Psychiatric disorders        
Depression * 1      
# participants affected / at risk     7/129 (5.43%)     12/127 (9.45%)     19/256 (7.42%)  
Renal and urinary disorders        
Haematuria * 1      
# participants affected / at risk     12/129 (9.30%)     7/127 (5.51%)     19/256 (7.42%)  
Leukocyturia * 1      
# participants affected / at risk     7/129 (5.43%)     6/127 (4.72%)     13/256 (5.08%)  
Respiratory, thoracic and mediastinal disorders        
Cough * 1      
# participants affected / at risk     8/129 (6.20%)     7/127 (5.51%)     15/256 (5.86%)  
Skin and subcutaneous tissue disorders        
Rash * 1      
# participants affected / at risk     4/129 (3.10%)     8/127 (6.30%)     12/256 (4.69%)  
Vascular disorders        
Hypertension * 1      
# participants affected / at risk     9/129 (6.98%)     6/127 (4.72%)     15/256 (5.86%)  
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA 10.0



  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This study was not blinded and not designed to demonstrate a safety benefit to stopping nucleoside analogues.


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