HIV heart risk: statin pill could save lives

NCT ID NCT02344290

Prevention Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This large phase 3 trial tested whether a daily statin (pitavastatin) can reduce the risk of heart attacks, strokes, and other cardiovascular events in adults with HIV who are on antiretroviral therapy. Over 7,700 participants from multiple countries took either the statin or a placebo. The study aimed to see if this simple prevention strategy could lower the added heart disease risk seen in people living with HIV.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Pitavastatin (a statin drug)
What this could lead to: If successful, this could establish a simple daily pill to prevent heart attacks and strokes in people with HIV, potentially becoming a standard part of HIV care.
What could go wrong: The trial is complete, but statins have side effects like muscle pain and increased blood sugar. Results may not apply to all HIV populations or regions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

7,769 people

The number who actually took part.

Started

Mar 2015

Finished

Aug 2023

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Individual with HIV-1 * Combination antiretroviral therapy (ART) for at least 180 days prior to study entry * CD4+ cell count greater than 100 cells/mm\^3 * Acceptable screening laboratories including: * Fasting low-density lipoprotein (LDL) cholesterol as follows: * If ASCVD risk score was less than 7.5%, LDL cholesterol must have been less than 190 mg/dL. * If ASCVD risk score was greater than or equal to 7.5% and less than or equal to 10%, LDL must have been less than 160 mg/dL. * If ASCVD risk score was greater than 10% and less than or equal to 15%, LDL must have been less than 130 mg/dL. * Participants with LDL less than 70 mg/dL were eligible regardless of the 10-year ASCVD risk score, in line with the ACC/AHA 2013 Prevention Guidelines. * Fasting triglycerides less than 500 mg/dL * Hemoglobin greater than or equal to 8 g/dL for female participants and greater than or equal to 9 g/dL for male participants * Glomerular filtration rate (GFR) greater than or equal to 60 mL/min/1.73m\^2 or creatinine clearance (CrCl) greater than or equal to 60 mL/min * Alanine aminotransferase (ALT) less than or equal to 2.5 x the upper limit of normal (ULN) * For persons with known chronic active hepatitis B or C, calculated fibrosis 4 score (FIB-4) must have been less than or equal to 3.25 * Ability and willingness of participant or legal representative to provide written informed consent Exclusion Criteria: * Clinical ASCVD, as defined by 2013 American College of Cardiology (ACC)/American Heart Association (AHA) guidelines, including a previous diagnosis of any of the following: * Acute myocardial infarction (AMI) * Acute coronary syndromes * Stable or unstable angina * Coronary or other arterial revascularization * Stroke * Transient ischemic attack (TIA) * Peripheral arterial disease presumed to be of atherosclerotic origin * Current diabetes mellitus with LDL greater than or equal to 70 mg/dL * 10-year ASCVD risk score estimated by Pooled Cohort Equations greater than 15% * Active cancer within 12 months prior to study entry, except successfully treated non-melanomatous skin cancer and Kaposi sarcoma without visceral organ involvement * Known decompensated cirrhosis * History of myositis or myopathy with active disease in the 180 days prior to study entry * Known untreated symptomatic thyroid disease * History of allergy or severe adverse reaction to statins * Use of specific immunosuppressants or immunomodulatory agents including but not limited to tacrolimus, sirolimus, rapamycin, mycophenolate, cyclosporine, tumor necrosis factor (TNF)-alpha blockers or antagonists, azathioprine, interferon, growth factors, or intravenous immunoglobulin (IVIG) in the 30 days prior to study entry. * Current use of erythromycin, colchicine, or rifampin * Use of any statin drugs, gemfibrozil, or PCSK9 inhibitors in the 90 days prior to study entry * Current use of an investigational new drug that would be contraindicated * Serious illness or trauma requiring systemic treatment or hospitalization in the 30 days prior to study entry * Current pregnancy or breastfeeding * Alcohol or drug use that, in the opinion of the site investigator, would interfere with completion of study procedures * Other medical, psychiatric, or psychological condition that, in the opinion of the site investigator, would interfere with completion of study procedures and or adherence to study drug

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Conditions

The condition(s) this trial relates to.

COVID-19 HIV infectious disease Inflammation myocardial infarction cardiovascular disorder prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiovascular diseases HIV

Contacts and locations

Locations

550 Clinic -University of Louisville CRS

Louisville, Kentucky, 40202, United States
AHF - South Beach CRS

Miami, Florida, 33140, United States
AHF-The Kinder Medical Group CRS

Miami, Florida, 33133, United States
AIDS Research and Treatment Center of the Treasure Coast CRS

Vero Beach, Florida, 32960, United States
Abbott Northwestern Hospital CRS

Minneapolis, Minnesota, 55407, United States
Alabama CRS*

Birmingham, Alabama, 35294, United States
Augusta University Research Institute, Inc. CRS

Augusta, Georgia, 30912, United States
Barranco CRS

Lima, 15063, Peru
Baystate Infectious Diseases Clinical Research CRS

Springfield, Massachusetts, 01199, United States
Bluegrass Care Clinic/University of Kentucky Research Foundation CRS

Lexington, Kentucky, 40536, United States
Boston Medical Center CRS

Boston, Massachusetts, 02118, United States
Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS*

Boston, Massachusetts, 02115, United States
Byramjee Jeejeebhoy Medical College (BJMC) CRS

Pune, Maharashtra, 411001, India
Capital Medical Associates, PC CRS

Washington D.C., District of Columbia, 20036, United States
Case Clinical Research Site*

Cleveland, Ohio, 44106, United States
Center of Translational AIDS Research, Lewis Katz School of Medicine at Temple University CRS

Philadelphia, Pennsylvania, 19140, United States
Centre hospitalier de l'Université Laval CRS

Québec, Quebec, G1V 4G2, Canada
Centro de Pesquisas Clínicas IC-HCFMUSP CRS

São Paulo, 05403-010, Brazil
Centro de Referencia e Treinamento DST/AIDS CRS

São Paulo, São Paulo, 04121-000, Brazil
Chapel Hill CRS*

Chapel Hill, North Carolina, 27599, United States
Chennai Antiviral Research and Treatment (CART) CRS

Chennai, Tamil Nadu, 600113, India
Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS

Chiang Mai, 50200, Thailand
Chronic Viral Illness Service CRS

Montreal, Quebec, H4A 3J1, Canada
Cincinnati Clinical Research Site*

Cincinnati, Ohio, 45219, United States
Columbia P&S CRS*

New York, New York, 10032-3732, United States
Community AIDS Network/Comprehensive Care Clinic CRS

Sarasota, Florida, 34237, United States
Cooper Univ. Hosp. CRS

Camden, New Jersey, 08103, United States
Dallas VA Medical Center CRS

Dallas, Texas, 75216, United States
Denver Public Health CRS

Denver, Colorado, 80204, United States
Department of Internal Medicine, University of Iowa Hospitals & Clinics CRS

Iowa City, Iowa, 52242, United States
Division of Infectious Diseases Clinical Research Center- Drexel University CRS

Philadelphia, Pennsylvania, 19102, United States
Duke University Medical Center CRS

Durham, North Carolina, 27710, United States
Durban International Clinical Research Site CRS

Durban, KwaZulu-Natal, 4052, South Africa
Eisenhower Health Center at Rimrock CRS

Palm Springs, California, 92264, United States
Famcru Crs

Tygerberg, Western Cape, 7505, South Africa
Florida Department of Health - Hillsborough County

Tampa, Florida, 33602, United States
GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS

Port-au-Prince, HT-6110, Haiti
Gaborone CRS

Gaborone, South-East District, Botswana
Georgetown University CRS (GU CRS)

Washington D.C., District of Columbia, 20007, United States
Greensboro CRS*

Greensboro, North Carolina, 27401, United States
HGNI HIV Family Care Clinic - HHFCC CRS

Nova Iguaçu, Rio de Janeiro, 26030-380, Brazil
Hamilton Health Sciences - Special Immunology Services Clinic CRS

Hamilton, Ontario, L8S 1A4, Canada
Harbor-UCLA CRS*

Torrance, California, 90502, United States
Henry Ford Hosp. CRS

Detroit, Michigan, 48202, United States
Hospital Clinic de Barcelona

Barcelona, 08036, Spain
Hospital Federal dos Servidores do Estado CRS

Rio de Janeiro, 20221-903, Brazil
Hospital General Universitario De Elche

Elche, 03203, Spain
Hospital General Universitario de Alicante

Alicante, 03010, Spain
Hospital Germans Trias i Pujol

Badalona, 080916, Spain
Hospital Gregorio Universitario Maranon

Madrid, 28007, Spain
Hospital Nossa Senhora da Conceicao CRS

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil
Hospital Universitario 12 de Octubre

Madrid, 28041, Spain
Hospital Universitario Clinico San Carlos

Madrid, 28040, Spain
Hospital Universitario La Paz

Madrid, 28046, Spain
Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain
Hospital Universitario Valle d'Hebron

Barcelona, 08003, Spain
Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain
Hospital Universitario de Basurto de Basurto

Bilbao, 48013, Spain
Hospital Universitario de Bellvitge

Barcelona, 08907, Spain
Houston AIDS Research Team CRS*

Houston, Texas, 77030, United States
Indiana University Infectious Diseases Research CRS

Indianapolis, Indiana, 46202, United States
Infectious Disease Clinical and Translational Research Center (CTRC) CRS

New York, New York, 10029, United States
Infectious Diseases Clinic, Washington DC Veterans Affairs Medical Center CRS

Washington D.C., District of Columbia, 20422, United States
Inova Heart and Vascular Institute CRS

Falls Church, Virginia, 22042, United States
Instituto de Infectologia Emilio Ribas CRS

São Paulo, 01246-900, Brazil
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS

Rio de Janeiro, 21040-360, Brazil
James J Peters VA Medical Center CRS

The Bronx, New York, 10468, United States
Johns Hopkins University CRS*

Baltimore, Maryland, 21205, United States
Joint Clinical Research Centre (JCRC)/Kampala Clinical Research Site

Kampala, Uganda
Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS

Port-au-Prince, HT-6110, Haiti
Los Angeles LGBT Center CRS

Los Angeles, California, 90232, United States
Malcom Randall VA Medical Center CRS

Gainesville, Florida, 32610, United States
Maple Leaf Research CRS

Toronto, Ontario, M5G 1K2, Canada
Massachusetts General Hospital CRS (MGH CRS)*

Boston, Massachusetts, 02114, United States
Medical College of Wisconsin, Inc. CRS

Milwaukee, Wisconsin, 53226, United States
Medical University of South Carolina: Division of Infectious Diseases CRS

Charleston, South Carolina, 29425, United States
Michael E. DeBakey VAMC REPRIEVE CRS

Houston, Texas, 77030, United States
Mills Clinical Research CRS

Los Angeles, California, 90069, United States
Milton Park CRS

Harare, Zimbabwe
Mount Sinai Beth Israel CRS*

New York, New York, 10003, United States
Mount Sinai Downtown CRS*

New York, New York, 10011, United States
Mount Sinai St. Luke's Morningside CRS*

New York, New York, 10025, United States
Mount Sinai West Samuels CRS*

New York, New York, 10019, United States
New Jersey Medical School Clinical Research Center CRS*

Newark, New Jersey, 07103, United States
Northwestern University CRS*

Chicago, Illinois, 60611, United States
Ohio State University CRS*

Columbus, Ohio, 43210, United States
Oklahoma State University Center for Health Sciences CRS

Tulsa, Oklahoma, 74127, United States
Orlando Immunology Center CRS

Orlando, Florida, 32803, United States
Penn Therapeutics, CRS*

Philadelphia, Pennsylvania, 19104, United States
Positive Health Clinic CRS

Pittsburgh, Pennsylvania, 15212, United States
Prisma Health CRS

Columbia, South Carolina, 29209, United States
Projeto Praça Onze Pesquisa em Saúde CRS

Rio de Janeiro, 20020-000, Brazil
Puerto Rico AIDS Clinical Trials Unit CRS*

San Juan, PR, 00935, Puerto Rico
Rush University CRS*

Chicago, Illinois, 60612, United States
San Miguel CRS

Lima, 32 - 15088, Peru
School of Medicine, Federal University of Minas Gerais CRS

Belo Horizonte, Minas Gerais, 30130-100, Brazil
Soweto ACTG CRS

Johannesburg, Gauteng, 1862, South Africa
Specialty Care Center CRS

Omaha, Nebraska, 68106, United States
St. John Newland Medical Associates CRS

Southfield, Michigan, 48075, United States
Stanford AIDS Clinical Trials Unit CRS

Palo Alto, California, 94304-5350, United States
Thai Red Cross AIDS Research Centre (TRC-ARC) CRS

Bangkok, 10330, Thailand
The Miriam Hospital Clinical Research Site (TMH CRS) CRS*

Providence, Rhode Island, 02906, United States
The Ponce de Leon Center CRS

Atlanta, Georgia, 30308-2012, United States
The University of Miami AIDS Clinical Research Unit (ACRU) CRS

Miami, Florida, 33136, United States
Toronto General Hospital CRS

Toronto, Ontario, M5G 2N2, Canada
Trinity Health and Wellness Center CRS

Dallas, Texas, 75208, United States
Tropical Medicine Foundation Dr. Heitor Vieira Dourado CRS

Manaus, Amazonas, 69040000, Brazil
Tufts Medical Center CRS

Boston, Massachusetts, 02111, United States
Tulane - Louisiana Community AIDS Research Program (T-LaCARP) CRS

New Orleans, Louisiana, 70112, United States
UCLA CARE Center CRS*

Los Angeles, California, 90035, United States
UCSD Antiviral Research Center CRS*

San Diego, California, 92103, United States
UIC Project WISH CRS

Chicago, Illinois, 60612, United States
UT Southwestern HIV/ID Clinical Trials Unit CRS

Dallas, Texas, 75235-9173, United States
Ucsf Hiv/Aids Crs*

San Francisco, California, 94110, United States
University of Arizona CRS

Tucson, Arizona, 85724, United States
University of Cape Town Lung Institute (UCTLI) CRS

Cape Town, Western Cape, 7700, South Africa
University of Colorado Hospital CRS*

Aurora, Colorado, 80045, United States
University of Miami Infectious Disease Research Unit at Jackson Memorial Hospital CRS

Miami, Florida, 33136, United States
University of Mississippi Medical Center CRS

Jackson, Mississippi, 39213, United States
University of Pittsburgh CRS*

Pittsburgh, Pennsylvania, 15213, United States
University of Rochester Adult HIV Therapeutic Strategies Network CRS*

Rochester, New York, 14642, United States
University of Southern California CRS*

Los Angeles, California, 90033-1079, United States
University of Toledo Medical Center CRS

Toledo, Ohio, 43614, United States
University of Washington AIDS CRS*

Seattle, Washington, 98104-9929, United States
VA Connecticut Healthcare System CRS

West Haven, Connecticut, 06516, United States
VA New York Harbor Healthcare System (NYHHS), NY Campus CRS

New York, New York, 10010, United States
VA West Los Angeles Medical Center CRS

Los Angeles, California, 90073, United States
Vancouver ID Research & Care Centre Society CRS

Vancouver, British Columbia, V6Z 2C7, Canada
Vanderbilt Therapeutics (VT) CRS*

Nashville, Tennessee, 37204, United States
Virginia Commonwealth University CRS

Richmond, Virginia, 23298, United States
Wake Forest Baptist Medical Center CRS

Winston-Salem, North Carolina, 27157, United States
Washington University Therapeutics (WT) CRS*

St Louis, Missouri, 63110-1010, United States
Weill Cornell Chelsea CRS*

New York, New York, 10010, United States
Weill Cornell Uptown CRS*

New York, New York, 10065, United States
Whitman-Walker Health CRS

Washington D.C., District of Columbia, 20005, United States
Wits Helen Joseph Hospital CRS (Wits HJH CRS)

Johannesburg, Gauteng, 2092, South Africa
Yale University CRS

New Haven, Connecticut, 06510, United States

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