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


  Baseline Characteristics
  Hide Baseline Characteristics

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
  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
  Hide Limitations and Caveats

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