Trial Outcomes & Findings for Bococizumab HIV Evaluation (B-HIVE) Study (NCT NCT02524106)
NCT ID: NCT02524106
Last Updated: 2019-06-19
Results Overview
The primary endpoint for the study is the percent change from baseline in fasting LDL-C at week 12.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
11 participants
Primary outcome timeframe
week 12
Results posted on
2019-06-19
Participant Flow
Participant milestones
| Measure |
Bococizumab
150 mg bococizumab injected subcutaneously every 2 weeks for a duration of 52 weeks
Bococizumab: PF-04950615 is a humanized monoclonal antibody against the proprotein convertase subtilisin kexin type 9 (PCSK9) enzyme responsible for the degradation of the low-density lipoprotein receptor (LDLR), being developed by Pfizer, Inc for the treatment of primary hyperlipidemia and mixed dyslipidemia.
|
Placebo
150 mg placebo injected subcutaneously every 2 weeks for a duration of 52 weeks
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
|
Overall Study
COMPLETED
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bococizumab HIV Evaluation (B-HIVE) Study
Baseline characteristics by cohort
| Measure |
Bococizumab
n=6 Participants
150 mg bococizumab injected subcutaneously every 2 weeks for a duration of 52 weeks
Bococizumab: PF-04950615 is a humanized monoclonal antibody against the proprotein convertase subtilisin kexin type 9 (PCSK9) enzyme responsible for the degradation of the low-density lipoprotein receptor (LDLR), being developed by Pfizer, Inc for the treatment of primary hyperlipidemia and mixed dyslipidemia.
|
Placebo
n=5 Participants
150 mg placebo injected subcutaneously every 2 weeks for a duration of 52 weeks
Placebo
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
|
Age, Continuous
|
64.83 years
n=39 Participants
|
55.4 years
n=41 Participants
|
56.5 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Caucasian
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · African-American
|
3 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=39 Participants
|
5 participants
n=41 Participants
|
11 participants
n=35 Participants
|
|
Absolute CD4 T cell
|
427 cells/mm3
n=39 Participants
|
834.8 cells/mm3
n=41 Participants
|
612.4 cells/mm3
n=35 Participants
|
PRIMARY outcome
Timeframe: week 12The primary endpoint for the study is the percent change from baseline in fasting LDL-C at week 12.
Outcome measures
| Measure |
Bococizumab
n=6 Participants
150 mg bococizumab injected subcutaneously every 2 weeks for a duration of 52 weeks
Bococizumab: PF-04950615 is a humanized monoclonal antibody against the proprotein convertase subtilisin kexin type 9 (PCSK9) enzyme responsible for the degradation of the low-density lipoprotein receptor (LDLR), being developed by Pfizer, Inc for the treatment of primary hyperlipidemia and mixed dyslipidemia.
|
Placebo
n=5 Participants
150 mg placebo injected subcutaneously every 2 weeks for a duration of 52 weeks
Placebo
|
|---|---|---|
|
Change of LDL-C From Baseline to Week 12
|
115.3 percentage change
Interval 75.0 to 170.0
|
90.3 percentage change
Interval 61.0 to 107.0
|
SECONDARY outcome
Timeframe: week 12Population: Patients living with well controlled HIV
The primary endpoint for the study is the percent change from baseline in fasting total Lp(a) at week 12.
Outcome measures
| Measure |
Bococizumab
n=6 Participants
150 mg bococizumab injected subcutaneously every 2 weeks for a duration of 52 weeks
Bococizumab: PF-04950615 is a humanized monoclonal antibody against the proprotein convertase subtilisin kexin type 9 (PCSK9) enzyme responsible for the degradation of the low-density lipoprotein receptor (LDLR), being developed by Pfizer, Inc for the treatment of primary hyperlipidemia and mixed dyslipidemia.
|
Placebo
n=5 Participants
150 mg placebo injected subcutaneously every 2 weeks for a duration of 52 weeks
Placebo
|
|---|---|---|
|
Change in Lp(a) From Entry to Week 12
|
327863.05 percentage change
Interval 54502.5 to 601223.6
|
344580.15 percentage change
Interval 49758.5 to 639401.8
|
Adverse Events
Bococizumab
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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
Priscilla Hsue, PI
University of California San Francisco
Phone: 415-206-8257
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place