Efficacy Study of Substitution of Darunavir/Ritonavir (DRV/r) for Dual-boosted Protease Inhibitors (DVD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cal Cohen, Community Research Initiative of New England
ClinicalTrials.gov Identifier:
NCT00543101
First received: October 11, 2007
Last updated: February 9, 2012
Last verified: February 2012
Results First Received: April 12, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Darunavir (DRV/r)
Drug: continue on current dual boosted PI

  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
Switch to DRV/r Switch to DRV/r at a dose of 600/100 BID for 48 weeks
Continue on Current Dual Boosted PI This is the control group. Subjects in this arm stay on their current regimen - a dual boosted PI combination.
Total Total of all reporting groups

Baseline Measures
    Switch to DRV/r     Continue on Current Dual Boosted PI     Total  
Number of Participants  
[units: participants]
  12     12     24  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     12     12     24  
>=65 years     0     0     0  
Age  
[units: years]
Median ( Full Range )
  46  
  ( 31 to 59 )  
  51  
  ( 36 to 64 )  
  50  
  ( 31 to 64 )  
Gender  
[units: participants]
     
Female     3     2     5  
Male     9     10     19  
Region of Enrollment  
[units: participants]
     
United States     12     12     24  



  Outcome Measures
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1.  Primary:   The Percentage of Participants With Successful Virologic Suppression   [ Time Frame: 24 weeks ]

2.  Secondary:   Economic Impact of a Substitution of Dual Boosted PIs With DRV/r   [ Time Frame: 48 weeks ]

3.  Secondary:   Lipid Fraction Results, Mean of the Change From Baseline to Week 24.   [ Time Frame: baseline and 24 weeks ]

4.  Secondary:   Treatment Satisfaction (+3, Much More Satisfied Now to -3, Much Less Satisfied Now)   [ Time Frame: 24 weeks ]


  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
The foremost problem was the small number of participants enrolled. By the time we were open for enrollment, most clinicians in the community had already switched their patients from dual boosted regimens to darunavir/ritonavir.


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