Trial Outcomes & Findings for Addition of Ezetimibe (Ezetrol®) to Ongoing Therapy With Rosuvastatin (Crestor®) in HIV Positive Patients Not Reaching Cholesterol Targets (NCT NCT00908011)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

43 participants

Primary outcome timeframe

3 months from baseline

Results posted on

2016-01-01

Participant Flow

Participant milestones

Participant milestones
Measure	Ezetimibe 10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day) Ezetimibe: 10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)- tablet, orally, 10mg/day for 12 weeks	Standard Care Increased dose of rosuvastatin to 20mg/day Rosuvastatin (standard care): Increased dose of rosuvastatin to 20mg/day
Overall Study STARTED	23	20
Overall Study COMPLETED	21	18
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Ezetimibe 10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day) Ezetimibe: 10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)- tablet, orally, 10mg/day for 12 weeks	Standard Care Increased dose of rosuvastatin to 20mg/day Rosuvastatin (standard care): Increased dose of rosuvastatin to 20mg/day
Overall Study Withdrawal by Subject	2	2

Baseline Characteristics

Addition of Ezetimibe (Ezetrol®) to Ongoing Therapy With Rosuvastatin (Crestor®) in HIV Positive Patients Not Reaching Cholesterol Targets

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ezetimibe n=23 Participants 10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day) Ezetimibe: 10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)- tablet, orally, 10mg/day for 12 weeks	Standard Care n=20 Participants Increased dose of rosuvastatin to 20mg/day Rosuvastatin (standard care): Increased dose of rosuvastatin to 20mg/day	Total n=43 Participants Total of all reporting groups
Region of Enrollment Canada	23 participants n=5 Participants	20 participants n=7 Participants	43 participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants	20 Participants n=7 Participants	43 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	56.5 Years STANDARD_DEVIATION 7.4 • n=5 Participants	57.0 Years STANDARD_DEVIATION 9.9 • n=7 Participants	57 Years STANDARD_DEVIATION 8.6 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	17 Participants n=7 Participants	39 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months from baseline

Outcome measures

Outcome measures
Measure	Ezetimibe n=21 Participants 10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day) Ezetimibe: 10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)- tablet, orally, 10mg/day for 12 weeks	Standard Care n=18 Participants Increased dose of rosuvastatin to 20mg/day Rosuvastatin (standard care): Increased dose of rosuvastatin to 20mg/day
The Primary Endpoint is the Difference in Final Value of Serum Apolipoprotein B Between Participants Treated With Rosuvastatin Versus Participants Treated With Both Rosuvastatin and Ezetimibe.	0.88 mmol/L Standard Deviation 0.22	0.89 mmol/L Standard Deviation 0.25

SECONDARY outcome

Timeframe: 3 months from baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months from baseline

Outcome measures

Outcome data not reported

Adverse Events

Ezetimibe

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Care

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

Dr. Greg Bondy

St. Paul's Hospital/University of B.C.

Phone: 604-806-8192

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place