HIV InfectionsNCT00099684
Safety, Effectiveness, and Tolerability of Ezetimibe Combined With Statins for the Treatment of High Cholesterol in HIV Infected Adults
A study testing Ezetimibe in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 42 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Ezetimibe
- How many people
- 44 participants
- Where
- 42 sitesin 2 countries
- Study dates
- Nov 2005to May 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV infected
- On ART for at least 3 months prior to study entry, and on stable ART for at least 30 days prior to study entry
- Taking one of the study-recommended statins for at least 3 months prior to study entry, and on stable statin therapy for at least 30 days immediately prior to study entry
- On lipid-lowering diet and exercise program for at least 30 days prior to screening, and willing to continue both for the duration of the study
- LDL-c of 130 mg/dL or greater within 30 days prior to study entry
- Willing to use acceptable forms of contraception
- If on hormone replacement therapy, must be on a stable dose or dose-equivalent therapy for at least 30 days prior to study entry, and must be willing to continue the same dose for the duration of the study. People taking physiologic testosterone replacement therapy are not excluded.
- If taking oral contraceptives, must be on a stable dose or dose-equivalent therapy for at least 30 days prior to study entry, and must be willing to continue the same dose for the duration of the study
Who cannot join
- Active cancer or new diagnosis of cancer within the last 5 years. People with skin cancers, including Kaposi's sarcoma, that do not require systemic treatment are not excluded.
- Prior use of ezetimibe
- Known allergy or sensitivity to ezetimibe or its components
- Diabetes mellitus or use of any diabetic medications within 30 days prior to study entry
- History of coronary heart disease
- History of or current congestive heart failure (New York Heart Association Class III or IV)
Show all 22Show fewer
- Known atherosclerotic disease risk (e.g., history of myocardial infection, bypass surgery, angioplasty, angina pectoris with a positive stress test or angiographic documentation)
- Vascular abnormalities (e.g., cerebrovascular disease, peripheral vascular disease, abdominal aortic aneurysm, or leg artery blockages)
- Untreated or uncontrolled hypothyroidism
- Current drug or alcohol abuse that may interfere with the study
- Testosterone therapy beyond normal physiologic levels of the hormone within 3 months prior to study entry
- Initiation or change in physiologic testosterone replacement therapy within 3 months prior to study entry
- Hormonal anabolic therapies within 3 months prior to study entry
- Systemic cancer chemotherapy or immunomodulators (e.g., growth factors, immune globulin, interleukins, and interferons) within 60 days prior to study entry
- Lipid-lowering agents (except statins) within 30 days prior to study entry
- Any corticosteroid therapy above replacement levels within 30 days prior to study entry
- Untreated or uncontrolled hypertension
- Active AIDS-defining opportunistic infection (OI) within 30 days prior to study entry. People who have no evidence of active disease and are receiving maintenance therapy for AIDS-related OIs are not excluded.
- Acute illness that would interfere with the study within 30 days prior to study entry
- Investigational agents. People using expanded access investigational antiretroviral drugs are not excluded.
- Decreased mental capacity that may interfere with the study
- Pregnant or breastfeeding
Trial locations and contacts
42 sites in 2 countries.
42 sites in 2 countries
United States41 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35924-2050
SUNY - Buffalo (Rochester)
Buffalo, New York, 14215
Rush-Presbyterian/St. Lukes (Chicago)
Chicago, Illinois, 60611-3015
Cook County Hospital Core Center
Chicago, Illinois, 60612
Feinberg School of Medicine, HIV/ACTU
Chicago, 60611-3015, Illinois, 60611-3015
University of Cincinnati
Cincinnati, Ohio, 45267-0405
MetroHealth Medical Center
Cleveland, Ohio, 44109-1998
Ohio State University
Columbus, Ohio, 43210
Dallas VA Medical Center
Dallas, Texas, 75235-9173
Duke University Medical Center
Durham, North Carolina
University of Texas, Galveston
Galveston, Texas, 77555-0435
University of Hawaii
Honolulu, Hawaii, 96816-2396
Indiana University Hospital
Indianapolis, Indiana, 46202-5250
Wishard Hospital
Indianapolis, Indiana, 46202
UCLA School of Medicine
Los Angeles, California, 77555-0435
University of Southern California
Los Angeles, California, 90033-1079
University of Miami
Miami, Florida, 33136-1013
University of Minnesota
Minneapolis, Minnesota, 55455-0392
Comprehensive Care Clinic
Nashville, Tennessee, 37203
Beth Israel Medical Center
New York, New York, 10003
Chelsea Clinic
New York, New York, 10011
NYU/Bellevue
New York, New York, 10016-6481
The Cornell Clinical Trials Unit
New York, New York, 10021
Columbia University
New York, New York, 10032-3784
Nebraska Health System
Omaha, Nebraska, 68198-5130
Presbyterian Medical Center - Univ. of PA
Philadelphia, Pennsylvania, 19104
University of Pennsylvania, Philadelphia
Philadelphia, Pennsylvania, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213-2582
Rhode Island Hospital
Providence, Rhode Island, 02906
Stanley Street Treatment and Resource
Providence, Rhode Island, 02906
The Miriam Hospital
Providence, Rhode Island, 02906
Community Health Network, Inc.
Rochester, New York, 14642-0001
University of Rochester Medical Center
Rochester, New York, 14642-0001
University of California, San Diego Antiviral Research Center
San Diego, California, 92103
San Francisco General Hospital
San Francisco, California, 94110
University of Washington (Seattle)
Seattle, Washington, 98104
San Mateo County AIDS Program
Stanford, California, 94305-5107
Santa Clara Valley Medical Center
Stanford, California, 94305-5107
Stanford University
Stanford, California, 94305-5107
Willow Clinic
Stanford, California, 94305-5107
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
About this study
Official title: A Pilot Study of the Safety, Efficacy, and Tolerability of Ezetimibe (Zetia) in Combination With Statin Therapy for the Treatment of Elevated LDL Cholesterol in HIV-Infected Subjects
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.
Read the detailed description
Lipid metabolism abnormalities are common complications of HIV therapy, particularly with PIs. Statins and other lipid-lowering agents are often prescribed to control elevated cholesterol levels in both HIV infected and uninfected people. However, both antiretroviral therapy (ART) and lipid-lowering drugs may be associated with cardiovascular disease, so there is a clear need to find a lipid-lowering drug with low toxicity. This study will evaluate the safety, efficacy, and tolerability of ezetimibe, a lipid-controlling agent, in combination with ongoing statin therapy in HIV infected people currently on ART.
This study will last 28 weeks. All participants will be required to continue their current stable statin therapy and ART for the duration of the study.
Participants will be randomly assigned to one of two arms. Arm 1 participants will receive ezetimibe daily for 12 weeks, no treatment for 4 weeks, then placebo daily for 12 weeks. Arm 2 participants will receive placebo daily for 12 weeks, no treatment for 4 weeks, and then ezetimibe daily for 12 weeks. There will be 9 study visits; they will occur at study screening, at study entry, and every 4 weeks thereafter. Clinical assessment and blood collection will occur at all visits. Participants will be asked to complete an adherence questionnaire at Weeks 4, 12, 20, and 28, and will also be encouraged to coenroll in ACTG A5128 (Consent for Use of Stored Patient Specimens for Future Testing).
- Conditions
- HIV Infections
- Being tested
- Ezetimibe
- Keywords
- Treatment Experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EzetimibeDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in directly measured fasting LDL-c while receiving ezetimibe compared to change while receiving placebo
changes in clinical symptoms and safety labs while receiving ezetimibe compared to changes in clinical symptoms while receiving placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2004 (estimated)
- Study startNov 2005
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Susan Koletar, MD, Study chair, Division of Infectious Diseases, Ohio State UniversityDominic Chow, MD, MPH, Study chair, University of Hawaii, Hawaii AIDS Clinical Research Program, Leahi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00099684
- Sponsor's protocol ID
- ACTG A5209
- Status last verified
- Oct 2012
- First submitted
- 17 Dec 2004
- Last updated
- 29 Oct 2012
- Results posted
- No
Publications
Calza L, Manfredi R, Chiodo F. Dyslipidaemia associated with antiretroviral therapy in HIV-infected patients. J Antimicrob Chemother. 2004 Jan;53(1):10-4. doi: 10.1093/jac/dkh013. Epub 2003 Nov 25.
PubMed 14645323Colagreco JP. Cardiovascular considerations in patients treated with HIV protease inhibitors. J Assoc Nurses AIDS Care. 2004 Jan-Feb;15(1):30-41. doi: 10.1177/1055329003256922.
PubMed 14983559Martinez E, Tuset M, Milinkovic A, Miro JM, Gatell JM. Management of dyslipidaemia in HIV-infected patients receiving antiretroviral therapy. Antivir Ther. 2004 Oct;9(5):649-63.
PubMed 15535403Visnegarwala F, Maldonado M, Sajja P, Minihan JL, Rodriguez-Barradas MC, Ong O, Lahart CJ, Hasan MQ, Balasubramanyam A, White AC Jr. Lipid lowering effects of statins and fibrates in the management of HIV dyslipidemias associated with antiretroviral therapy in HIV clinical practice. J Infect. 2004 Nov;49(4):283-90. doi: 10.1016/j.jinf.2003.09.006.
PubMed 15474625
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Safety, Efficacy, and Tolerability of Ezetimibe (Zetia) in Combination With Statin Therapy for the Treatment of Elevated LDL Cholesterol in HIV-Infected Subjects
- ClinicalTrials.gov ID
- NCT00099684
- Acronym / sponsor ID
- ACTG A5209
- Conditions
- HIV Infections
- Keywords
- Treatment Experienced
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Nov 2005
- Study completion
- May 2007 (actual)
- First posted
- 20 Dec 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Lipid metabolism abnormalities are common complications of HIV therapy, particularly with PIs. Statins and other lipid-lowering agents are often prescribed to control elevated cholesterol levels in both HIV infected and uninfected people. However, both antiretroviral therapy (ART) and lipid-lowering drugs may be associated with cardiovascular disease, so there is a clear need to find a lipid-lowering drug with low toxicity. This study will evaluate the safety, efficacy, and tolerability of ezetimibe, a lipid-controlling agent, in combination with ongoing statin therapy in HIV infected people currently on ART.
This study will last 28 weeks. All participants will be required to continue their current stable statin therapy and ART for the duration of the study.
Participants will be randomly assigned to one of two arms. Arm 1 participants will receive ezetimibe daily for 12 weeks, no treatment for 4 weeks, then placebo daily for 12 weeks. Arm 2 participants will receive placebo daily for 12 weeks, no treatment for 4 weeks, and then ezetimibe daily for 12 weeks. There will be 9 study visits; they will occur at study screening, at study entry, and every 4 weeks thereafter. Clinical assessment and blood collection will occur at all visits. Participants will be asked to complete an adherence questionnaire at Weeks 4, 12, 20, and 28, and will also be encouraged to coenroll in ACTG A5128 (Consent for Use of Stored Patient Specimens for Future Testing).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- HIV infected
- On ART for at least 3 months prior to study entry, and on stable ART for at least 30 days prior to study entry
- Taking one of the study-recommended statins for at least 3 months prior to study entry, and on stable statin therapy for at least 30 days immediately prior to study entry
- On lipid-lowering diet and exercise program for at least 30 days prior to screening, and willing to continue both for the duration of the study
- LDL-c of 130 mg/dL or greater within 30 days prior to study entry
Key exclusion criteria (22 listed)
- Active cancer or new diagnosis of cancer within the last 5 years. People with skin cancers, including Kaposi's sarcoma, that do not require systemic treatment are not excluded.
- Prior use of ezetimibe
- Known allergy or sensitivity to ezetimibe or its components
- Diabetes mellitus or use of any diabetic medications within 30 days prior to study entry
- History of coronary heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ezetimibe | Drug | – |
Primary outcome
Change in directly measured fasting LDL-c while receiving ezetimibe compared to change while receiving placebo
changes in clinical symptoms and safety labs while receiving ezetimibe compared to changes in clinical symptoms while receiving placebo
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2012.
- Background: PubMed 14645323Calza L, Manfredi R, Chiodo F. Dyslipidaemia associated with antiretroviral therapy in HIV-infected patients. J Antimicrob Chemother. 2004 Jan;53(1):10-4. doi: 10.1093/jac/dkh013. Epub 2003 Nov 25.
- Background: PubMed 14983559Colagreco JP. Cardiovascular considerations in patients treated with HIV protease inhibitors. J Assoc Nurses AIDS Care. 2004 Jan-Feb;15(1):30-41. doi: 10.1177/1055329003256922.
- Background: PubMed 15535403Martinez E, Tuset M, Milinkovic A, Miro JM, Gatell JM. Management of dyslipidaemia in HIV-infected patients receiving antiretroviral therapy. Antivir Ther. 2004 Oct;9(5):649-63.
- Background: PubMed 15474625Visnegarwala F, Maldonado M, Sajja P, Minihan JL, Rodriguez-Barradas MC, Ong O, Lahart CJ, Hasan MQ, Balasubramanyam A, White AC Jr. Lipid lowering effects of statins and fibrates in the management of HIV dyslipidemias associated with antiretroviral therapy in HIV clinical practice. J Infect. 2004 Nov;49(4):283-90. doi: 10.1016/j.jinf.2003.09.006.
- Click here for more information about ACTG A5128Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Koletar, MD study chair
Division of Infectious Diseases, Ohio State University
Dominic Chow, MD, MPH study chair
University of Hawaii, Hawaii AIDS Clinical Research Program, Leahi Hospital
42 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ezetimibe in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 42 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in directly measured fasting LDL-c while receiving ezetimibe compared to change while receiving placebo. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00099684, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2012.