Clinical trialNCT00099684CompletedInterventional

Safety, Effectiveness, and Tolerability of Ezetimibe Combined With Statins for the Treatment of High Cholesterol in HIV Infected Adults

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment44HIV Infections

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Anti-HIV drugs, especially protease inhibitors (PIs), have been linked to lipid metabolism problems, including elevations in low density lipoprotein cholesterol (LDL-c), triglycerides, and total cholesterol. Ezetimibe is a lipid-controlling drug; statins are part of another class of lipid-lowering drugs popularly prescribed to people with high cholesterol. The purpose of this study is to determine the safety, effectiveness, and tolerability of ezetimibe in combination with statin therapy in adults who are taking anti-HIV drugs and have high cholesterol. Study hypothesis: In HIV infected adults, ezetimibe in combination with statin therapy will result in significantly lower LDL-c compared to statin therapy alone.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Dominic Chow, MD, MPH
University of Hawaii, Hawaii AIDS Clinical Research Program, Leahi Hospital
Study Chair
clinicaltrials.gov ↗
Susan Koletar, MD
Division of Infectious Diseases, Ohio State University
Study Chair
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

42 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Puerto Rico

University of Puerto Rico
San Juan, Puerto Rico

United States

University of Alabama at Birmingham
Birmingham, Alabama, United States
Ucla School of Medicine
Los Angeles, California, United States
University of Southern California
Los Angeles, California, United States
University of California, San Diego Antiviral Research Center
San Diego, California, United States
San Francisco General Hospital
San Francisco, California, United States
San Mateo County Aids Program
Stanford, California, United States
Santa Clara Valley Medical Center
Stanford, California, United States
Stanford University
Stanford, California, United States
Willow Clinic
Stanford, California, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
University of Miami
Miami, Florida, United States
University of Hawaii
Honolulu, Hawaii, United States
Cook County Hospital Core Center
Chicago, Illinois, United States
Rush-Presbyterian/st. Lukes (chicago)
Chicago, Illinois, United States
Feinberg School of Medicine, Hiv/actu
Chicago, 60611-3015, Illinois, United States
Indiana University Hospital
Indianapolis, Indiana, United States
Wishard Hospital
Indianapolis, Indiana, United States
University of Minnesota
Minneapolis, Minnesota, United States
Nebraska Health System
Omaha, Nebraska, United States
Suny - Buffalo (rochester)
Buffalo, New York, United States
Beth Israel Medical Center
New York, New York, United States
Chelsea Clinic
New York, New York, United States
Columbia University
New York, New York, United States
Nyu/bellevue
New York, New York, United States
the Cornell Clinical Trials Unit
New York, New York, United States
Community Health Network, Inc.
Rochester, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Metrohealth Medical Center
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Presbyterian Medical Center - Univ. of Pa
Philadelphia, Pennsylvania, United States
University of Pennsylvania, Philadelphia
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Stanley Street Treatment and Resource
Providence, Rhode Island, United States
the Miriam Hospital
Providence, Rhode Island, United States
Comprehensive Care Clinic
Nashville, Tennessee, United States
Dallas Va Medical Center
Dallas, Texas, United States

2 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Ezetimibe →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 30 Nov 2005
Primary completion: —
Completion: 31 May 2007
Last update posted: 29 Oct 2012
Registered enrollment: 44
Registry id: NCT00099684

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.