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HIV InfectionsPhase 3NCT00006412

Safety and Effectiveness of Fenofibrate and Pravastatin in HIV-Positive Patients With Abnormal Blood Lipids

A Phase 3 study testing Pravastatin sodium and Fenofibrate in people with HIV Infections and Lipodystrophy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 58 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to compare the safety and effectiveness of fenofibrate and pravastatin in treating HIV-positive patients who have abnormal levels of fat (lipids) in the blood. Increased lipids in the blood associated with HIV infection and anti-HIV drugs is a growing problem. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections, Lipodystrophy
What is being tested?
Pravastatin sodium and Fenofibrate
How many people
630 participants
Where
58 sitesin 2 countries
Study dates
Start not givento May 2003
Phase
Phase 3
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

  • Patients may be eligible for this study if they:
  • Are HIV-positive.
  • Are at least 18 years old.
  • Are on a lipid-lowering diet based on the patient's statement and have been exercising for at least 30 days before being screened for the study. Patients will be asked if they were counseled by their health care provider. The lipid-lowering diet and exercise program do not have to be prescribed by a physician.
  • Have a triglyceride (TG) level of at least 200 mg/dl and low-density lipoprotein (LDL) level of at least 130 mg/dl after fasting for 8 to 12 hours.
  • Have been treated with anti-HIV drugs for more than 6 months. Patients must be taking the anti-HIV drugs regularly for at least 4 weeks before they enter the study. Patients must be taking anti-HIV drugs regularly for at least 8 weeks if they have changed from taking protease inhibitor (PI) anti-HIV drugs to non-PI anti-HIV drugs. Any combination without a PI must lower the patient's HIV viral levels, as determined by the patient's physician.
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  • Are willing, if able to become pregnant, to use 2 reliable types of birth control while taking the study drug(s) and for 1 month after stopping the drug(s).
  • Have a negative pregnancy test.
  • (This reflects a change in inclusion requirements.)

Who cannot join

  • Patients will not be eligible for the study if they:
  • Have a history of heart disease.
  • Have uncontrolled high blood pressure within 4 weeks of study entry.
  • Have liver disease.
  • Have gall bladder disease or symptoms within 3 months prior to study entry or symptoms of gallstones.
  • Had surgery to remove their gallbladder within 3 months prior to study entry.
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  • Have diabetes requiring drug treatment or diabetes not controlled by diet.
  • Have hypothyroidism (low thyroid activity).
  • Are allergic or sensitive to the study drug(s) or to other lipid-lowering drugs.
  • Have rhabdomyolysis (a muscle disease).
  • Have taken any prescription or non-prescription lipid-lowering drug within 14 days prior to study entry or for over 24 weeks in the past.
  • Take prescription lipid-lowering agents, other than those given by the study, and non-prescription lipid-lowering agents such as garlic supplements.
  • Have failed previous statin or fibrate therapy (after 24 weeks of treatment) or have had side effects from these drugs.
  • Receive or have received (within 14 days of study entry) treatment not approved by the FDA. Anti-HIV medications and immune-based treatments not approved by the FDA may be allowed on a case-by-case basis with the approval of the protocol team.
  • Were given systemic chemotherapy for cancer other than Kaposi's sarcoma (KS).
  • Were given radiation therapy within 30 days of study entry.
  • Take drugs that increase risk of muscle disease (such as cyclosporine, erythromycin, itraconazole, and ketoconazole), within 14 days of study entry.
  • Take or have taken levothyroxine and liothyronine for hypothyroidism.
  • Take high doses of testosterone.
  • Take creatine monophosphate or drugs that affect the immune system, within 30 days of study entry.
  • Abuse drugs or alcohol, and the doctor thinks this may interfere with the study.
  • Are pregnant or breast-feeding.
  • Had a scheduled anti-HIV treatment withdrawal prior to study entry.
  • (This reflects a change in exclusion requirements.)

Trial locations and contacts

58 sites in 2 countries.

58 sites in 2 countries

United States57 sites

  • Emory Univ

    Atlanta, Georgia, 30308

  • Johns Hopkins Hosp

    Baltimore, Maryland, 21287

  • Univ of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Harvard (Massachusetts Gen Hosp)

    Boston, Massachusetts, 02114

  • Boston Med Ctr

    Boston, Massachusetts, 02118

  • Beth Israel Deaconess - West Campus

    Boston, Massachusetts, 02215

  • Brigham and Women's Hosp

    Boston, Massachusetts, 02215

  • SUNY / Erie County Med Ctr at Buffalo

    Buffalo, New York, 14215

  • Univ of North Carolina

    Chapel Hill, North Carolina, 275997215

  • Carolinas Med Ctr

    Charlotte, North Carolina, 28203

  • Northwestern Univ Med School

    Chicago, Illinois, 60611

  • The CORE Ctr

    Chicago, Illinois, 60612

  • Univ of Cincinnati

    Cincinnati, Ohio, 452670405

  • Case Western Reserve Univ

    Cleveland, Ohio, 44106

  • MetroHealth Med Ctr

    Cleveland, Ohio, 441091998

  • Ohio State Univ Hosp Clinic

    Columbus, Ohio, 432101228

  • Univ of Texas, Southwestern Med Ctr of Dallas

    Dallas, Texas, 75390

  • Denver Dept of Health and Hosps

    Denver, Colorado, 80262

  • Univ of Colorado Health Sciences Ctr

    Denver, Colorado, 80262

  • Duke Univ Med Ctr

    Durham, North Carolina, 27710

  • Univ of Texas Galveston

    Galveston, Texas, 775550435

  • Moses H Cone Memorial Hosp

    Greensboro, North Carolina, 27401

  • Univ of Hawaii

    Honolulu, Hawaii, 96816

  • Indiana Univ Hosp

    Indianapolis, Indiana, 462025250

  • Methodist Hosp of Indiana / Life Care Clinic

    Indianapolis, Indiana, 46202

  • Wishard Hosp

    Indianapolis, Indiana, 46202

  • Univ of Southern California / LA County USC Med Ctr

    Los Angeles, California, 900331079

  • UCLA CARE Ctr

    Los Angeles, California, 90095

  • Willow Clinic

    Menlo Park, California, 94025

  • Univ of Miami School of Medicine

    Miami, Florida, 331361013

  • Univ of Minnesota

    Minneapolis, Minnesota, 55455

  • Vanderbilt Univ Med Ctr

    Nashville, Tennessee, 37203

  • Beth Israel Med Ctr

    New York, New York, 10003

  • Cornell Clinical Trials Unit - Chelsea Clinic

    New York, New York, 10011

  • Bellevue Hosp / New York Univ Med Ctr

    New York, New York, 10016

  • Cornell Univ Med Ctr

    New York, New York, 10021

  • Mount Sinai Med Ctr

    New York, New York, 10029

  • Columbia Presbyterian Med Ctr

    New York, New York, 10032

  • Univ of Nebraska Med Ctr

    Omaha, Nebraska, 681985130

  • Philadelphia Veterans Administration Med Ctr

    Philadelphia, Pennsylvania, 19104

  • Univ of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Univ of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Rhode Island Hosp / Brown Univ

    Providence, Rhode Island, 02903

  • Brown Univ / Miriam Hosp

    Providence, Rhode Island, 02906

  • Miriam Hosp / Brown Univ

    Providence, Rhode Island, 02906

  • Community Health Network Inc

    Rochester, New York, 14642

  • St Mary's Hosp (Univ of Rochester/Infectious Diseases)

    Rochester, New York, 14642

  • Univ of Rochester Medical Center

    Rochester, New York, 14642

  • Univ of California, San Diego

    San Diego, California, 92103

  • University of California San Francisco

    San Francisco, California, 941104206

  • Univ of California San Francisco

    San Francisco, California, 94110

  • Univ of Washington

    Seattle, Washington, 98104

  • San Mateo AIDS Program / Stanford Univ

    Stanford, California, 943055107

  • Stanford Univ Med Ctr

    Stanford, California, 943055107

  • Harbor UCLA Med Ctr

    Torrance, California, 90502

  • Tripler Army Med Ctr

    Tripler AMC, Hawaii, 96859

  • Julio Arroyo

    West Columbia, South Carolina, 29169

Other trials in United States

Puerto Rico1 site

  • Univ of Puerto Rico

    San Juan, 009365067

Other trials in Puerto Rico

About this study

Official title: A Prospective, Multicenter, Randomized Trial Comparing the Efficacy and Safety of Fenofibrate Versus Pravastatin in HIV-Infected Subjects With Lipid Abnormalities

The purpose of this study is to compare the safety and effectiveness of fenofibrate and pravastatin in treating HIV-positive patients who have abnormal levels of fat (lipids) in the blood.

Increased lipids in the blood associated with HIV infection and anti-HIV drugs is a growing problem. The drugs used in this study are known to reduce certain lipids, but little is known about their safety and effectiveness. This study will see if one of the drugs is safer and more effective than the other, or if combining the drugs is the safest and most effective way to lower lipids. This study has been changed. On June 26, 2001, this study was reviewed by the Data and Safety Monitoring Board (DSMB). The DSMB is an independent board monitoring the progress of the study. The review showed that neither pravastatin nor fenofibrate alone were effective in reaching all the cholesterol and triglyceride goals. There were no safety concerns. It is not known if the combination of fenofibrate and pravastatin is effective and safe. Therefore, it is important to continue this study.

Read the detailed description

Lipid disorders associated with HIV infection and antiretroviral therapy are of growing concern. There is little information available on the safety and efficacy of statins or fibrates in the treatment of HIV-associated hyperlipidemias. Fenofibrate and pravastatin both are able to reduce low-density lipoproteins (LDL) and triglycerides (TG), but it is unclear whether one therapy will be more effective than the other, or if combination therapy will be needed to achieve desirable reductions in both LDL and TG. [AS PER AMENDMENT 12/13/01: The NIAID HIV Therapeutic Trials Data and Safety Monitoring Board (DSMB) met June 26, 2001 to review the interim results. The interim monitoring plan for this study states that accrual into either single-agent therapy arm should stop if the response rate failed to meet a pre-specified minimum at the time of interim review. The DSMB found that this stopping criterion was met for each single-therapy arm. The DSMB recommended that patients currently on single-agent therapy be offered the opportunity to initiate dual-agent therapy, regardless of time on study. There were no safety concerns.]

Patients are randomized to either Arm A or Arm B and stratified by gender, TG level, and number of cardiovascular risk factors. Patients add daily fenofibrate (Arm A) or pravastatin (Arm B) to their antiretroviral therapy for 48 weeks. Evaluations at Week 12 determine LDL, TG, and high-density lipid (HDL) levels. Patients who achieve clinical goals for these levels stay on the drug for the rest of the study. Patients who do not achieve the goals by Week 12 receive a combination of pravastatin and fenofibrate for the rest of the study. At regular clinic visits, patients have physical exams and are questioned about their medications, diet, and exercise. Blood samples are drawn for clinical evaluations, including lipid profiles and HIV-1 RNA monitoring. [AS PER AMENDMENT 12/13/01: On June 26, 2001, the DSMB reviewed interim results and determined that the response rates for both arms met the stopping rule for futility. As a result, all patients who were currently on single-agent therapy were offered the opportunity to initiate dual-agent therapy regardless of time on study. No additional accrual was sought; however, exceptions were made for patients who were in screening at the time of the DSMB review. These patients were given the option of starting single- or dual-agent therapy. The DSMB recommended that all patients on dual-agent therapy be followed for 32 weeks to obtain additional safety and efficacy data. Further endpoints will be analyzed after Week 12 of single-agent therapy or Week 32 of dual-agent therapy.]

Being tested
Pravastatin sodium, Fenofibrate
Keywords
Hyperlipidemia, Procetofen, Pravastatin, Antilipemic Agents
Medical subject headings
HIV Infections, Lipodystrophy, Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pravastatin sodiumDrug

  • FenofibrateDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2001 (estimated)
  2. Study completionMay 2003

Resources

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 3
Primary purpose
Treatment
Enrolment
630 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00006412
Sponsor's protocol ID
A5087
Other IDs
10917, ACTG A5087, AACTG A5087
Status last verified
Oct 2021
First submitted
13 Oct 2000
Last updated
1 Nov 2021
Results posted
No

Publications

  • Aberg JA, Zackin RA, Brobst SW, Evans SR, Alston BL, Henry WK, Glesby MJ, Torriani FJ, Yang Y, Owens SI, Fichtenbaum CJ; ACTG 5087 Study Team. A randomized trial of the efficacy and safety of fenofibrate versus pravastatin in HIV-infected subjects with lipid abnormalities: AIDS Clinical Trials Group Study 5087. AIDS Res Hum Retroviruses. 2005 Sep;21(9):757-67. doi: 10.1089/aid.2005.21.757.

    PubMed 16218799

  • Evans SR, Fichtenbaum CJ, Aberg JA; A5087 Study Team. Comparison of direct and indirect measurement of LDL-C in HIV-infected individuals: ACTG 5087. HIV Clin Trials. 2007 Jan-Feb;8(1):45-52. doi: 10.1310/hct0801-45.

    PubMed 17434848

  • Fichtenbaum CJ, Yeh TM, Evans SR, Aberg JA. Treatment with pravastatin and fenofibrate improves atherogenic lipid profiles but not inflammatory markers in ACTG 5087. J Clin Lipidol. 2010 Jul-Aug;4(4):279-87. doi: 10.1016/j.jacl.2010.04.003.

    PubMed 20824151

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pravastatin sodium and Fenofibrate in people with HIV Infections and Lipodystrophy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 58 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 9 inclusion and 24 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 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00006412, which also lists 3 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 1 Nov 2021.

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