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

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ClinicalTrials.gov Identifier: NCT00543101
Recruitment Status : Completed
First Posted : October 12, 2007
Results First Posted : August 17, 2010
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Community Research Initiative of New England

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Darunavir (DRV/r)
Drug: continue on current dual boosted PI

  Participant Flow


  Baseline Characteristics

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 
Overall Participants Analyzed 
[Units: Participants]
 12   12   24 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      12 100.0%      12 100.0%      24 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Median (Full Range)
 46 
 (31 to 59) 
 51 
 (36 to 64) 
 50 
 (31 to 64) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      3  25.0%      2  16.7%      5  20.8% 
Male      9  75.0%      10  83.3%      19  79.2% 
Region of Enrollment 
[Units: Participants]
     
United States   12   12   24 


  Outcome Measures

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

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