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 ]

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.


  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: Clavin Cohen MD
Organization: Community Research Initiative of New England (CRINE)
phone: 617 502 1700
e-mail: ccohen@crine.org


No publications provided


Responsible Party: Cal Cohen, Community Research Initiative of New England
ClinicalTrials.gov Identifier: NCT00543101     History of Changes
Other Study ID Numbers: 07-142
Study First Received: October 11, 2007
Results First Received: April 12, 2010
Last Updated: February 9, 2012
Health Authority: United States: Institutional Review Board