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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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


  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.


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