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

History of Changes

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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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 ]

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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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

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Site Investigators (PIs) agree not to individually publish the results of the study. They may participate in a joint publication of the study results with the sponsor.

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.

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

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