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

PHASE2CompletedINTERVENTIONAL
Enrollment

99

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

October 31, 2013

Study Completion Date

October 31, 2013

Conditions
HIV-1 Infection
Interventions
DRUG

Niacin

Extended-release niacin will be given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)

DRUG

Aspirin

Aspirin 325 mg will be given by mouth in the evening with extended-release niacin through week 24.

DRUG

Fenofibrate

Fenofibrate will be administered as 200 mg by mouth once daily for 24 weeks.

Trial Locations (14)

10016

NY Univ. HIV/AIDS CRS (401), New York

27401

Moses H. Cone Memorial Hospital CRS (3203), Greensboro

27516

Unc Aids Crs (3201), Chapel Hill

27710

Duke Univ. Med. Ctr. Adult CRS (1601), Durham

35294

Alabama Therapeutics CRS (5801), Birmingham

44106

Case CRS (2501), Cleveland

45267

Univ. of Cincinnati CRS (2401), Cincinnati

60611

Northwestern University CRS (2701), Chicago

80045

University of Colorado Hospital CRS (6101), Aurora

90095

UCLA CARE Center CRS (601), Los Angeles

90502

Harbor-UCLA Med. Ctr. CRS (603), Torrance

98104

University of Washington AIDS CRS (1401), Seattle

90033-1079

University of Southern California (1201), Los Angeles

07103

New Jersey Medical School-Adult Clinical Research Ctr. CRS (31477), Newark

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

NETWORK

NCT01426438 - Endothelial Function, Lipoproteins, and Inflammation With Low HDL Cholesterol in HIV: ER Niacin Versus Fenofibrate | Biotech Hunter | Biotech Hunter