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BRAVO: Background Regimen of Raltegravir on Virologic Outcome (BRAVO)

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ClinicalTrials.gov Identifier: NCT00751530
Recruitment Status : Completed
First Posted : September 12, 2008
Results First Posted : June 17, 2011
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Community Research Initiative of New England

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Condition HIV Infections
Intervention Drug: raltegravir
Enrollment 442
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Protease Inhibitor Group Non-protease Inhibitor
Hide Arm/Group Description Subjects who required a protease inhibitor in their new ART regimen Subjects who did not take a protease inhibitor in their regimen
Period Title: Overall Study
Started 332 110
Completed 332 110
Not Completed 0 0
Arm/Group Title Protease Inhibitor Group Non-protease Inhibitor Total
Hide Arm/Group Description Subjects who required a protease inhibitor in their new ART regimen Subjects who did not take a protease inhibitor in their regimen Total of all reporting groups
Overall Number of Baseline Participants 254 86 340
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 254 participants 86 participants 340 participants
<=18 years
2
   0.8%
1
   1.2%
3
   0.9%
Between 18 and 65 years
247
  97.2%
82
  95.3%
329
  96.8%
>=65 years
5
   2.0%
3
   3.5%
8
   2.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 254 participants 86 participants 340 participants
Female
25
   9.8%
13
  15.1%
38
  11.2%
Male
229
  90.2%
73
  84.9%
302
  88.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 254 participants 86 participants 340 participants
254 86 340
1.Primary Outcome
Title Percentage of Participants With Viral Load < 400 Copies /mL at Week 12.
Hide Description The HIV RNA (viral load) was measured using standard of care testing via local laboratories.
Time Frame 12 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Protease Inhibitor Group Non-protease Inhibitor
Hide Arm/Group Description:
Subjects who required a protease inhibitor in their new ART regimen
Subjects who did not take a protease inhibitor in their regimen
Overall Number of Participants Analyzed 254 86
Measure Type: Number
Unit of Measure: Percentage of Participants
84 86
2.Secondary Outcome
Title Percentage of Participants With Viral Load < 75 Copies/ mL at Week 12
Hide Description The HIV RNA (viral load) was measured using standard of care testing via local laboratories.
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Protease Inhibitor Group Non-protease Inhibitor
Hide Arm/Group Description:
Subjects who required a protease inhibitor in their new ART regimen
Subjects who did not take a protease inhibitor in their regimen
Overall Number of Participants Analyzed 254 86
Measure Type: Number
Unit of Measure: Percentage of participants
84 86
3.Secondary Outcome
Title CD4 Cell Changes Among Participants in PI vs Non-PI Group
Hide Description CD4 cell counts were measured using standard of care testing via local laboratories.
Time Frame baseline to 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Protease Inhibitor Group Non-protease Inhibitor
Hide Arm/Group Description:
Subjects who required a protease inhibitor in their new ART regimen
Subjects who did not take a protease inhibitor in their regimen
Overall Number of Participants Analyzed 129 44
Mean (Full Range)
Unit of Measure: cells/mm3
-96.6
(-310 to 768)
-134.8
(-385 to 42)
4.Secondary Outcome
Title 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)
Hide Description The baseline GSS is calculated by the sum of resistance scores for each drug in the regimen. For each drug in the regimen a resistance score of 0, 0.5 or 1 was assigned for high, low or no levels of resistance, respectfully. The resistance assignment was based on either the Stanford database interpretation or presence of primary IAS mutation levels of resistance. Inclusion of maraviroc or new use of enfuvirtide in the regimen was scored a 1.0. The sum of the scores of the active drugs, not including raltegravir, constituted the baseline GSS.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Protease Inhibitor Group Non-protease Inhibitor
Hide Arm/Group Description:
Subjects who required a protease inhibitor in their new ART regimen
Subjects who did not take a protease inhibitor in their regimen
Overall Number of Participants Analyzed 254 86
Mean (Full Range)
Unit of Measure: score
1.8
(0 to 5.4)
1.7
(0 to 3.5)
5.Secondary Outcome
Title Percentage of Participants Using Etravirine in Background Regimen
Hide Description These results report the percent of participants using Etravirine in the background regimen.
Time Frame Background regimen (no specific time frame)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Protease Inhibitor Group Non-protease Inhibitor
Hide Arm/Group Description:
Subjects who required a protease inhibitor in their new ART regimen
Subjects who did not take a protease inhibitor in their regimen
Overall Number of Participants Analyzed 100 58
Measure Type: Number
Unit of Measure: Percentage of Participants
33 58
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Protease Inhibitor Group Non-protease Inhibitor
Hide Arm/Group Description Subjects who required a protease inhibitor in their new ART regimen Subjects who did not take a protease inhibitor in their regimen
All-Cause Mortality
Protease Inhibitor Group Non-protease Inhibitor
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Protease Inhibitor Group Non-protease Inhibitor
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Protease Inhibitor Group Non-protease Inhibitor
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
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.
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.
Results Point of Contact
Name/Title: Project Manager
Organization: Community Research Initiative
Phone: 617 502 1700
Responsible Party: Community Research Initiative of New England
ClinicalTrials.gov Identifier: NCT00751530     History of Changes
Other Study ID Numbers: 07-11
First Submitted: September 11, 2008
First Posted: September 12, 2008
Results First Submitted: July 22, 2010
Results First Posted: June 17, 2011
Last Update Posted: July 2, 2017