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 ]
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Measure Type Secondary
Measure Title Virological Response [Per Protocol (PP), TLOVR - Switch Equals Failure, <200 Copies/ml, Week 144]
Measure Description Virological response is defined as the number of patients in the PP population with a plasma viral load < 200 HIV RNA copies/ml at Week 144. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). In addition, any switch in background nucleoside reverse transcriptase inhibitors (NRTIs) equaled failure* (referred to as a Switch Equals Failure analysis). *Discontinuations and rechallenge with NRTIs are taken into account until Week 144
Time Frame week 144  
Safety Issue No  

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.
PP population: all randomised patients who took study drug, and who did not deviate from the protocol. This excludes 13 patients with major protocol deviations.

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

Measured Values
    DRV/r+2NRTIs     DRV/r  
Number of Participants Analyzed  
[units: participants]
  121     122  
Virological Response [Per Protocol (PP), TLOVR - Switch Equals Failure, <200 Copies/ml, Week 144]  
[units: Participants]
  102     95  

No statistical analysis provided for Virological Response [Per Protocol (PP), TLOVR - Switch Equals Failure, <200 Copies/ml, 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
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: EMEA Medical Affairs Director Virology
Organization: Jan-Cilag Germany
phone: +49 7624 907580


No publications provided by Janssen-Cilag International NV

Publications automatically indexed to this study:

Responsible Party: Janssen-Cilag International NV
ClinicalTrials.gov Identifier: NCT00458302     History of Changes
Other Study ID Numbers: CR013159, TMC114HIV3006, 2006-006437-40
Study First Received: April 6, 2007
Results First Received: February 4, 2010
Last Updated: December 14, 2012
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment