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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:
ClinicalTrials.gov Identifier:
NCT00458302
First Posted: April 10, 2007
Last Update Posted: December 19, 2012
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.
Information provided by (Responsible Party):
Janssen-Cilag International NV
Results First Submitted: February 4, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: HIV Infections
AIDS Virus
Human Immunodeficiency Virus
Acquired Immunodeficiency Syndrome Virus
Intervention: Drug: darunavir (DRV, TMC114)

  Participant Flow


  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 
Overall Participants Analyzed 
[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 
[1] plasma viral load (HIV-1 RNA copies/ml)
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) 


  Outcome Measures
  Show All Outcome Measures

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


  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.


  More Information