Trial · NCT01426438

Endothelial Function, Lipoproteins, and Inflammation With Low HDL Cholesterol in HIV: ER Niacin Versus Fenofibrate

NCT01426438, Phase 2, Completed, Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections; results first posted 2014-10-21

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Endothelial Function, Lipoproteins, and Inflammation With Low HDL Cholesterol in HIV: ER Niacin Versus Fenofibrate. Trials, record NCT01426438. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01426438

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Endothelial Function, Lipoproteins, and Inflammation With Low HDL Cholesterol in HIV: ER Niacin Versus Fenofibrate
NCT number: NCT01426438
Status: Completed
Phases: Phase 2
Enrollment: 99 participants, actual
Lead sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Conditions: HIV-1 Infection
Interventions: Niacin, Aspirin, Fenofibrate
First posted: 2011-08-31
Last updated: 2016-02-03
Results first posted: 2014-10-21

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Absolute Change in Relative FMD (%)	0 and 24 weeks	The absolute change in maximum relative flow mediated dilation (FMD) (%) of the brachial artery from baseline to week 24.
Secondary	Change in Cholesterol	0 and 24 weeks	Absolute change in total cholesterol from week 0 to week 24.
Secondary	Change in Triglycerides	0 and 24 weeks	Change in Triglycerides (mg/dL) from week 0 to week 24.
Secondary	Men: Change in HDL Cholesterol	0 and 24 weeks	Among men, change in HDL Cholesterol (mg/dL) from week 0 to week 24.
Secondary	Women: Change in HDL Cholesterol	0 and 24 weeks	Among women, change in HDL cholesterol (mg/dL) from week 0 to week 24.
Secondary	Change in HDL Particles	0 and 24 weeks	Change in total HDL particles from week 0 to week 24
Secondary	Change in Non-HDL Cholesterol	0 and 24 weeks	Change in non-HDL Cholesterol (mg/dL) from week 0 to week 24.
Secondary	Change in LDL Cholesterol	0 and 24 weeks	Change in LDL cholesterol (mg/dL) from week 0 to week 24.
Secondary	Change in Small LDL Particles	0 and 24 weeks	Change in Small LDL particles from week 0 to week 24.
Secondary	Change in Large HDL Particles	0 and 24 weeks	Change in Large HDL Particles from week 0 to week 24

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Absolute Change in Relative FMD (%)	0 and 24 weeks	This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.	% FMD	MEDIAN
SECONDARY	Change in Cholesterol	0 and 24 weeks	This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan and had lipid panels at weeks 0 and 24.	mg/dL	MEDIAN
SECONDARY	Change in Triglycerides	0 and 24 weeks	This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.	mg/dL	MEDIAN
SECONDARY	Men: Change in HDL Cholesterol	0 and 24 weeks	Men in the as-treated analysis population, limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.	mg/dL	MEDIAN
SECONDARY	Women: Change in HDL Cholesterol	0 and 24 weeks	Women in the as-treated analysis population, limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.	mg/dL	MEDIAN
SECONDARY	Change in HDL Particles	0 and 24 weeks	This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.	nmol/L	MEDIAN
SECONDARY	Change in Non-HDL Cholesterol	0 and 24 weeks	This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.	mg/dL	MEDIAN
SECONDARY	Change in LDL Cholesterol	0 and 24 weeks	This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.	mg/dL	MEDIAN
SECONDARY	Change in Small LDL Particles	0 and 24 weeks	This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.	nmol/L	MEDIAN
SECONDARY	Change in Large HDL Particles	0 and 24 weeks	This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.	nmol/L	MEDIAN

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group28

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Absolute Change in Relative FMD (%)	Arm A: Extended-release Niacin With Aspirin	0.60	Inter-Quartile Range -1.58 to 2.28	% FMD
Absolute Change in Relative FMD (%)	Arm B: Fenofibrate	0.50	Inter-Quartile Range -0.97 to 2.98	% FMD
Change in Cholesterol	Arm A: Extended-release Niacin With Aspirin	-9	Inter-Quartile Range -26 to 3	mg/dL
Change in Cholesterol	Arm B: Fenofibrate	-2	Inter-Quartile Range -28 to 25	mg/dL
Change in Triglycerides	Arm A: Extended-release Niacin With Aspirin	-65	Inter-Quartile Range -163 to 8	mg/dL
Change in Triglycerides	Arm B: Fenofibrate	-54	Inter-Quartile Range -113 to -10	mg/dL
Men: Change in HDL Cholesterol	Arm A: Extended-release Niacin With Aspirin	3	Inter-Quartile Range 0 to 9	mg/dL
Men: Change in HDL Cholesterol	Arm B: Fenofibrate	6.5	Inter-Quartile Range 0 to 12	mg/dL
Women: Change in HDL Cholesterol	Arm A: Extended-release Niacin With Aspirin	16	Inter-Quartile Range -1 to 22	mg/dL
Women: Change in HDL Cholesterol	Arm B: Fenofibrate	8	Inter-Quartile Range 5 to 13	mg/dL

1 to 10 of 28Source ClinicalTrials.gov

See all 28 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm A: Extended-release Niacin With Aspirin	50
Overall Study	STARTED	Arm B: Fenofibrate	49
Overall Study	COMPLETED	Arm A: Extended-release Niacin With Aspirin	35
Overall Study	COMPLETED	Arm B: Fenofibrate	39
Overall Study	NOT COMPLETED	Arm A: Extended-release Niacin With Aspirin	15
Overall Study	NOT COMPLETED	Arm B: Fenofibrate	10

Source ClinicalTrials.gov

Adverse events46

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal pain	Gastrointestinal disorders	Arm A: Extended-release Niacin With Aspirin	3	50
other	Abdominal pain	Gastrointestinal disorders	Arm B: Fenofibrate	1	49
other	Diarrhoea	Gastrointestinal disorders	Arm A: Extended-release Niacin With Aspirin	3	50
other	Diarrhoea	Gastrointestinal disorders	Arm B: Fenofibrate	0	49
other	Nausea	Gastrointestinal disorders	Arm A: Extended-release Niacin With Aspirin	7	50
other	Nausea	Gastrointestinal disorders	Arm B: Fenofibrate	2	49
other	Vomiting	Gastrointestinal disorders	Arm A: Extended-release Niacin With Aspirin	4	50
other	Vomiting	Gastrointestinal disorders	Arm B: Fenofibrate	1	49
other	Fatigue	General disorders	Arm A: Extended-release Niacin With Aspirin	3	50
other	Fatigue	General disorders	Arm B: Fenofibrate	0	49

1 to 10 of 46Source ClinicalTrials.gov

See all 46 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm A: Extended-release Niacin With Aspirin
Total, all-cause mortality	Arm B: Fenofibrate
Total, other adverse events	Arm A: Extended-release Niacin With Aspirin	47	50
Total, other adverse events	Arm B: Fenofibrate	34	49
Total, serious adverse events	Arm A: Extended-release Niacin With Aspirin	1	50
Total, serious adverse events	Arm B: Fenofibrate	0	49

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25979307	DERIVED	PubMed
30535188	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01AI068636	AIDS Clinical Trials Group Network	KURITZKES, DANIEL R.	SOCIAL AND SCIENTIFIC SYSTEMS, INC.	NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES	2006 to 2010

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Arm A: Extended-release Niacin With Aspirin vs Arm B: Fenofibrate: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

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