Trial Outcomes & Findings for BRAVO: Background Regimen of Raltegravir on Virologic Outcome (NCT NCT00751530)

Results Overview

The HIV RNA (viral load) was measured using standard of care testing via local laboratories.

Recruitment status

COMPLETED

Target enrollment

442 participants

Primary outcome timeframe

12 Weeks

Results posted on

2017-07-02

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	332	110
Overall Study COMPLETED	332	110
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

BRAVO: Background Regimen of Raltegravir on Virologic Outcome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Protease Inhibitor Group n=254 Participants Subjects who required a protease inhibitor in their new ART regimen	Non-protease Inhibitor n=86 Participants Subjects who did not take a protease inhibitor in their regimen	Total n=340 Participants Total of all reporting groups
Age, Categorical <=18 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	247 Participants n=5 Participants	82 Participants n=7 Participants	329 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	13 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	229 Participants n=5 Participants	73 Participants n=7 Participants	302 Participants n=5 Participants
Region of Enrollment United States	254 participants n=5 Participants	86 participants n=7 Participants	340 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 Weeks

The HIV RNA (viral load) was measured using standard of care testing via local laboratories.

Outcome measures

Outcome measures
Measure	Protease Inhibitor Group n=254 Participants Subjects who required a protease inhibitor in their new ART regimen	Non-protease Inhibitor n=86 Participants Subjects who did not take a protease inhibitor in their regimen
Percentage of Participants With Viral Load < 400 Copies /mL at Week 12.	84 Percentage of Participants	86 Percentage of Participants

SECONDARY outcome

Timeframe: 12 weeks

The HIV RNA (viral load) was measured using standard of care testing via local laboratories.

Outcome measures

Outcome measures
Measure	Protease Inhibitor Group n=254 Participants Subjects who required a protease inhibitor in their new ART regimen	Non-protease Inhibitor n=86 Participants Subjects who did not take a protease inhibitor in their regimen
Percentage of Participants With Viral Load < 75 Copies/ mL at Week 12	84 Percentage of participants	86 Percentage of participants

SECONDARY outcome

Timeframe: baseline to 24 Weeks

CD4 cell counts were measured using standard of care testing via local laboratories.

Outcome measures

Outcome measures
Measure	Protease Inhibitor Group n=129 Participants Subjects who required a protease inhibitor in their new ART regimen	Non-protease Inhibitor n=44 Participants Subjects who did not take a protease inhibitor in their regimen
CD4 Cell Changes Among Participants in PI vs Non-PI Group	-96.6 cells/mm3 Full Range NA • Interval -310.0 to 768.0	-134.8 cells/mm3 Full Range NA • Interval -385.0 to 42.0

SECONDARY outcome

Timeframe: Baseline

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.

Outcome measures

Outcome measures
Measure	Protease Inhibitor Group n=254 Participants Subjects who required a protease inhibitor in their new ART regimen	Non-protease Inhibitor n=86 Participants Subjects who did not take a protease inhibitor in their regimen
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)	1.8 score Interval 0.0 to 5.4	1.7 score Interval 0.0 to 3.5

SECONDARY outcome

Timeframe: Background regimen (no specific time frame)

These results report the percent of participants using Etravirine in the background regimen.

Outcome measures

Outcome measures
Measure	Protease Inhibitor Group n=100 Participants Subjects who required a protease inhibitor in their new ART regimen	Non-protease Inhibitor n=58 Participants Subjects who did not take a protease inhibitor in their regimen
Percentage of Participants Using Etravirine in Background Regimen	33 Percentage of Participants	58 Percentage of Participants

Adverse Events

Protease Inhibitor Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-protease Inhibitor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Project Manager

Community Research Initiative

Phone: 617 502 1700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER