Trial Outcomes & Findings for Study of Niacin on Endothelial Function in HIV-infected Subjects With Low High Density Lipoprotein Cholesterol Levels (NCT NCT00986986)

Results Overview

Brachial arterial flow-mediated dilation (FMD), assessed by high-resolution ultrasonography, reflects endothelium-dependent vasodilator function. The primary outcome is the change in FMD from baseline to study week 12.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Two time points (baseline and study week 12)

Results posted on

2012-12-18

Participant Flow

Recruitment was through the University of Hawaii, Hawaii Center for AIDS

Participant milestones

Participant milestones
Measure	Active Drug (Extended Release Niacin) Subjects in this arm will be given 12 weeks of extended release niacin	Observation Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin
Overall Study STARTED	10	10
Overall Study COMPLETED	10	9
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Active Drug (Extended Release Niacin) Subjects in this arm will be given 12 weeks of extended release niacin	Observation Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Study of Niacin on Endothelial Function in HIV-infected Subjects With Low High Density Lipoprotein Cholesterol Levels

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Drug (Extended Release Niacin) n=10 Participants Subjects in this arm will be given 12 weeks of extended release niacin	Observation n=10 Participants Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin	Total n=20 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	10 Participants n=5 Participants	10 Participants n=7 Participants	20 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	49.96 years STANDARD_DEVIATION 11.60 • n=5 Participants	47.72 years STANDARD_DEVIATION 10.81 • n=7 Participants	48.84 years STANDARD_DEVIATION 10.94 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Two time points (baseline and study week 12)

Population: HIV infected patients with HDL-C \< 40

Brachial arterial flow-mediated dilation (FMD), assessed by high-resolution ultrasonography, reflects endothelium-dependent vasodilator function. The primary outcome is the change in FMD from baseline to study week 12.

Outcome measures

Outcome measures
Measure	Extended Release Niacin n=10 Participants HIV infected individuals receiving extended release niacin	Observation n=9 Participants Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin
Change in Flow-mediated Vasodilation (FMD) From Baseline to Study Week 12	6.36 percentage change in FMD Interval 4.85 to 7.87	2.73 percentage change in FMD Interval 0.95 to 4.51

PRIMARY outcome

Timeframe: 12 weeks

Flow mediated vasodilation is a marker of endothelial function

Outcome measures

Outcome measures
Measure	Extended Release Niacin n=10 Participants HIV infected individuals receiving extended release niacin	Observation n=9 Participants Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin
Flow Mediated Vasodilation	4.51 percentage change in FMD Interval 4.46 to 8.32	3.25 percentage change in FMD Interval 1.95 to 4.85

SECONDARY outcome

Timeframe: Two time points (baseline and study week 12)

HDL, often referred to "Good cholesterol levels", will be obtained in both arms. HDL is a marker of coronary heart disease.

Outcome measures

Outcome measures
Measure	Extended Release Niacin n=10 Participants HIV infected individuals receiving extended release niacin	Observation n=9 Participants Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin
High-density Lipoprotein Cholesterol (HDL) Change From Baseline to Study Week 12	42.0 mg/dl Interval 39.3 to 43.5	27.0 mg/dl Interval 24.0 to 39.0

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome data not reported

Adverse Events

Active Drug (Extended Release Niacin)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Observation

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

Dominic Chow

University of Hawaii at Manoa

Phone: (808)737-2751

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place