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
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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
Five multicenter sites were used these included medical and research clinics.

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
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.

Participant Flow:   Overall Study
    Switch to DRV/r     Continue on Current Dual Boosted PI  
STARTED     12     12  
COMPLETED     12     12  
NOT COMPLETED     0     0  



  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 ]

Measure Type Primary
Measure Title The Percentage of Participants With Successful Virologic Suppression
Measure Description Amount of HIV RNA copies per ml blood collected from subjects as measured by the Ultra-sensitive HIV-1 PCR (Roche Cobas). Successful virologic suppression is defined as < 50 copies/ml blood. The result is the percentage of participants with successful virologic suppression.
Time Frame 24 weeks  
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.
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.

Measured Values
    Switch to DRV/r     Continue on Current Dual Boosted PI  
Number of Participants Analyzed  
[units: participants]
  12     12  
The Percentage of Participants With Successful Virologic Suppression  
[units: Percentage of Participants]
  100     100  

No statistical analysis provided for The Percentage of Participants With Successful Virologic Suppression



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

Measure Type Secondary
Measure Title Economic Impact of a Substitution of Dual Boosted PIs With DRV/r
Measure Description To assess the economic impact of DRV/r substitution for dual boosted PIs, we compared the average wholesale acquisition costs for the drugs in US Dollars ($) per month. The wholesale acquisition cost in US dollars ($) for each ART regimen was determined and the difference between the cost for the experimental and control groups was calculated and reported as US dollar savings per month.
Time Frame 48 weeks  
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.
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.

Measured Values
    Switch to DRV/r     Continue on Current Dual Boosted PI  
Number of Participants Analyzed  
[units: participants]
  12     12  
Economic Impact of a Substitution of Dual Boosted PIs With DRV/r  
[units: US dollars savings per month]
  217     0  

No statistical analysis provided for Economic Impact of a Substitution of Dual Boosted PIs With DRV/r



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

Measure Type Secondary
Measure Title Lipid Fraction Results, Mean of the Change From Baseline to Week 24.
Measure Description We collected fasting total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides from all participants in both arms of the study. We calculated the differences between the values at week 24 and baseline for the participants in both arms. We reported the mean of the change from baseline to week 24.
Time Frame baseline and 24 weeks  
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.
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.

Measured Values
    Switch to DRV/r     Continue on Current Dual Boosted PI  
Number of Participants Analyzed  
[units: participants]
  12     12  
Lipid Fraction Results, Mean of the Change From Baseline to Week 24.  
[units: mg/dL]
   
Change in Total Cholesterol     -6     2  
Change in LDL-Cholesterol     -4     2  
Change in HDL-Cholesterol     -1     1  
Change in Triglycerides     -13     0  

No statistical analysis provided for Lipid Fraction Results, Mean of the Change From Baseline to Week 24.



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

Measure Type Secondary
Measure Title Treatment Satisfaction (+3, Much More Satisfied Now to -3, Much Less Satisfied Now)
Measure Description Participants in the experimental arm completed treatment satisfaction questionnaires at 24 weeks, and the control arm at 48 weeks (24 weeks after mid-study crossover to boosted darunavir). The questionnaires used numeric satisfaction scales (+3 much more satisfied now to -3 much less satisfied now). We reported the median and ranges for each question for each study arm.
Time Frame 24 weeks  
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.
No text entered.

Reporting Groups
  Description
Switch to DRV/r Switch to DRV/r at a dose of 600/100 BID for 48 weeks
Crossover Week 48 At week 24 the dual PI arm subjects remaining undetectable, crossed over to the DRV/r arm and were followed for an additional 24 weeks.

Measured Values
    Switch to DRV/r     Crossover Week 48  
Number of Participants Analyzed  
[units: participants]
  12     7  
Treatment Satisfaction (+3, Much More Satisfied Now to -3, Much Less Satisfied Now)  
[units: Units on a Scale (+3 to -3)]
Median ( Full Range )
   
How satisfied are your with your current treatment     3  
  ( 0 to 3 )  
  2.5  
  ( 2 to 3 )  
How satisfied are you with any side-effects     2  
  ( 0 to 3 )  
  2.5  
  ( 2 to 3 )  
How convenient is your treatment     3  
  ( -1 to 3 )  
  3  
  ( 2 to 3 )  
How well does your treatment fit your lifestyle     3  
  ( -1 to 3 )  
  3  
  ( 2 to 3 )  
Would you recommend your treatment to someone else     3  
  ( 0 to 3 )  
  2.5  
  ( 2 to 3 )  
How likely are you to continue your treatment     3  
  ( 0 to 3 )  
  2.5  
  ( 1 to 3 )  

No statistical analysis provided for Treatment Satisfaction (+3, Much More Satisfied Now to -3, Much Less Satisfied Now)




  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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