BRAVO: Background Regimen of Raltegravir on Virologic Outcome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daniel Skiest, MD, Community Research Initiative of New England
ClinicalTrials.gov Identifier:
NCT00751530
First received: September 11, 2008
Last updated: July 31, 2012
Last verified: July 2012
Results First Received: July 22, 2010  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Retrospective
Condition: HIV Infections
Intervention: Drug: raltegravir

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Protease Inhibitor Group Subjects who required a protease inhibitor in their new ART regimen
Non-protease Inhibitor Subjects who did not take a protease inhibitor in their regimen

Participant Flow:   Overall Study
    Protease Inhibitor Group     Non-protease Inhibitor  
STARTED     332     110  
COMPLETED     332     110  
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.
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Reporting Groups
  Description
Protease Inhibitor Group Subjects who required a protease inhibitor in their new ART regimen
Non-protease Inhibitor Subjects who did not take a protease inhibitor in their regimen
Total Total of all reporting groups

Baseline Measures
    Protease Inhibitor Group     Non-protease Inhibitor     Total  
Number of Participants  
[units: participants]
  254     86     340  
Age  
[units: participants]
     
<=18 years     2     1     3  
Between 18 and 65 years     247     82     329  
>=65 years     5     3     8  
Gender  
[units: participants]
     
Female     25     13     38  
Male     229     73     302  
Region of Enrollment  
[units: participants]
     
United States     254     86     340  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Viral Load < 400 Copies /mL at Week 12.   [ Time Frame: 12 Weeks ]

2.  Secondary:   Percentage of Participants With Viral Load < 75 Copies/ mL at Week 12   [ Time Frame: 12 weeks ]

3.  Secondary:   CD4 Cell Changes Among Participants in PI vs Non-PI Group   [ Time Frame: baseline to 24 Weeks ]

4.  Secondary:   Baseline Genotypic Sensitivity Score (GSS). The Minimal Value Was 0 and the Maximum Values Was 5.4. (0 = Minimal to no Activity in Regimen and 5.4 = High to Maximal Activity in Regimen)   [ Time Frame: Baseline ]

5.  Secondary:   Percentage of Participants Using Etravirine in Background Regimen   [ Time Frame: Background regimen (no specific time frame) ]


  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
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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:
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: Project Manager
Organization: Community Research Initiative
phone: 617 502 1700
e-mail: pmacht@crine.org


No publications provided


Responsible Party: Daniel Skiest, MD, Community Research Initiative of New England
ClinicalTrials.gov Identifier: NCT00751530     History of Changes
Other Study ID Numbers: 07-11
Study First Received: September 11, 2008
Results First Received: July 22, 2010
Last Updated: July 31, 2012
Health Authority: United States: Institutional Review Board