Trial Outcomes & Findings for High Intensity Lipid Lowering Following Acute Coronary Syndromes for Persons Living With HIV (NCT NCT02841774)

NCT ID: NCT02841774

Last Updated: 2022-10-18

Results Overview

Mean percent change in fasting LDL-cholesterol at Week 2 and Week 14

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 10 participants
• Primary outcome timeframe: Week 2 and Week 14
• Results posted on: 2022-10-18

Participant Flow

Participant milestones

Measure	Moderate Intensity Group pravastatin 40mg daily for 12 weeks Pravastatin: 40mg daily (Weeks 2 - 14)	High Intensity Group rosuvastatin 20 - 40 mg daily for 12 weeks Rosuvastatin: 20mg daily (Weeks 2 - 14); at Week 6, if AST, AST, and CK \<+1.5 x ULN, and LDL-c is \>60 and decreased by less than 25% compared with week 2, then dose will be increased to rosuvastatin 40mg daily
Overall Study STARTED	6	4
Overall Study COMPLETED	6	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

High Intensity Lipid Lowering Following Acute Coronary Syndromes for Persons Living With HIV

Baseline characteristics by cohort

Measure	Moderate Intensity Group n=6 Participants pravastatin 40mg daily for 12 weeks Pravastatin: 40mg daily (Weeks 2 - 14)	High Intensity Group n=4 Participants rosuvastatin 20 - 40 mg daily for 12 weeks Rosuvastatin: 20mg daily (Weeks 2 - 14); at Week 6, if AST, AST, and CK \<+1.5 x ULN, and LDL-c is \>60 and decreased by less than 25% compared with week 2, then dose will be increased to rosuvastatin 40mg daily	Total n=10 Participants Total of all reporting groups
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	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 2 and Week 14

Mean percent change in fasting LDL-cholesterol at Week 2 and Week 14

Outcome measures

Measure	Moderate Intensity Group n=6 Participants pravastatin 40mg daily for 12 weeks Pravastatin: 40mg daily (Weeks 2 - 14)	High Intensity Group n=4 Participants rosuvastatin 20 - 40 mg daily for 12 weeks Rosuvastatin: 20mg daily (Weeks 2 - 14); at Week 6, if AST, AST, and CK \<+1.5 x ULN, and LDL-c is \>60 and decreased by less than 25% compared with week 2, then dose will be increased to rosuvastatin 40mg daily
Mean Percent Change in Fasting LDL-cholesterol	15.0 Percent decrease Interval -9.0 to 30.1	41.6 Percent decrease Interval 35.7 to 47.7

PRIMARY outcome

Timeframe: 14 weeks

Number of Grade 3 or above adverse events

Outcome measures

Measure	Moderate Intensity Group n=6 Participants pravastatin 40mg daily for 12 weeks Pravastatin: 40mg daily (Weeks 2 - 14)	High Intensity Group n=4 Participants rosuvastatin 20 - 40 mg daily for 12 weeks Rosuvastatin: 20mg daily (Weeks 2 - 14); at Week 6, if AST, AST, and CK \<+1.5 x ULN, and LDL-c is \>60 and decreased by less than 25% compared with week 2, then dose will be increased to rosuvastatin 40mg daily
Treatment-emergent Adverse Events	0 Participants	0 Participants

Adverse Events

Moderate Intensity Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

High Intensity Group

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. Matthew Feinstein

Northwestern University

Phone: 3126643278

Email: matthewjfeinstein@northwestern.edu

Results disclosure agreements

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