Evaluating the Use of Pitavastatin to Reduce the Risk of Cardiovascular Disease in HIV-Infected Adults

PHASE3CompletedINTERVENTIONAL
Enrollment

7,769

Participants

Timeline

Start Date

March 26, 2015

Primary Completion Date

August 21, 2023

Study Completion Date

August 21, 2023

Conditions
HIVCardiovascular Diseases
Interventions
DRUG

Pitavastatin

One tablet (4 mg) taken once daily, orally with or without food

DRUG

Placebo

One tablet taken once daily, orally with or without food

Trial Locations (137)

1862

Soweto ACTG CRS, Johannesburg

2092

Wits Helen Joseph Hospital CRS (Wits HJH CRS), Johannesburg

4052

Durban International Clinical Research Site CRS, Durban

7505

Famcru Crs, Tygerberg

7700

University of Cape Town Lung Institute (UCTLI) CRS, Cape Town

10003

Mount Sinai Beth Israel CRS*, New York

10010

VA New York Harbor Healthcare System (NYHHS), NY Campus CRS, New York

Weill Cornell Chelsea CRS*, New York

10011

Mount Sinai Downtown CRS*, New York

10019

Mount Sinai West Samuels CRS*, New York

10025

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

10029

Infectious Disease Clinical and Translational Research Center (CTRC) CRS, New York

10065

Weill Cornell Uptown CRS*, New York

10330

Thai Red Cross AIDS Research Centre (TRC-ARC) CRS, Bangkok

10468

James J Peters VA Medical Center CRS, The Bronx

14642

University of Rochester Adult HIV Therapeutic Strategies Network CRS*, Rochester

15063

Barranco CRS, Lima

15212

Positive Health Clinic CRS, Pittsburgh

15213

University of Pittsburgh CRS*, Pittsburgh

19102

Division of Infectious Diseases Clinical Research Center- Drexel University CRS, Philadelphia

19104

Penn Therapeutics, CRS*, Philadelphia

19140

Center of Translational AIDS Research, Lewis Katz School of Medicine at Temple University CRS, Philadelphia

20005

Whitman-Walker Health CRS, Washington D.C.

20007

Georgetown University CRS (GU CRS), Washington D.C.

20036

Capital Medical Associates, PC CRS, Washington D.C.

20422

Infectious Diseases Clinic, Washington DC Veterans Affairs Medical Center CRS, Washington D.C.

21205

Johns Hopkins University CRS*, Baltimore

22042

Inova Heart and Vascular Institute CRS, Falls Church

23298

Virginia Commonwealth University CRS, Richmond

27157

Wake Forest Baptist Medical Center CRS, Winston-Salem

27401

Greensboro CRS*, Greensboro

27599

Chapel Hill CRS*, Chapel Hill

27710

Duke University Medical Center CRS, Durham

28007

Hospital Gregorio Universitario Maranon, Madrid

28034

Hospital Universitario Ramon y Cajal, Madrid

28040

Hospital Universitario Clinico San Carlos, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28046

Hospital Universitario La Paz, Madrid

29010

Hospital Universitario Virgen de la Victoria, Málaga

29209

Prisma Health CRS, Columbia

29425

Medical University of South Carolina: Division of Infectious Diseases CRS, Charleston

30912

Augusta University Research Institute, Inc. CRS, Augusta

32610

Malcom Randall VA Medical Center CRS, Gainesville

32803

Orlando Immunology Center CRS, Orlando

32960

AIDS Research and Treatment Center of the Treasure Coast CRS, Vero Beach

33133

AHF-The Kinder Medical Group CRS, Miami

33136

The University of Miami AIDS Clinical Research Unit (ACRU) CRS, Miami

University of Miami Infectious Disease Research Unit at Jackson Memorial Hospital CRS, Miami

33140

AHF - South Beach CRS, Miami

33602

Florida Department of Health - Hillsborough County, Tampa

34237

Community AIDS Network/Comprehensive Care Clinic CRS, Sarasota

35294

Alabama CRS*, Birmingham

37204

Vanderbilt Therapeutics (VT) CRS*, Nashville

39213

University of Mississippi Medical Center CRS, Jackson

40202

550 Clinic -University of Louisville CRS, Louisville

40536

Bluegrass Care Clinic/University of Kentucky Research Foundation CRS, Lexington

43210

Ohio State University CRS*, Columbus

43614

University of Toledo Medical Center CRS, Toledo

44106

Case Clinical Research Site*, Cleveland

45219

Cincinnati Clinical Research Site*, Cincinnati

46202

Indiana University Infectious Diseases Research CRS, Indianapolis

48013

Hospital Universitario de Basurto de Basurto, Bilbao

48075

St. John Newland Medical Associates CRS, Southfield

48202

Henry Ford Hosp. CRS, Detroit

50200

Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS, Chiang Mai

52242

Department of Internal Medicine, University of Iowa Hospitals & Clinics CRS, Iowa City

53226

Medical College of Wisconsin, Inc. CRS, Milwaukee

55407

Abbott Northwestern Hospital CRS, Minneapolis

60611

Northwestern University CRS*, Chicago

60612

Rush University CRS*, Chicago

UIC Project WISH CRS, Chicago

68106

Specialty Care Center CRS, Omaha

70112

Tulane - Louisiana Community AIDS Research Program (T-LaCARP) CRS, New Orleans

74127

Oklahoma State University Center for Health Sciences CRS, Tulsa

75208

Trinity Health and Wellness Center CRS, Dallas

75216

Dallas VA Medical Center CRS, Dallas

77030

Houston AIDS Research Team CRS*, Houston

Michael E. DeBakey VAMC REPRIEVE CRS, Houston

80045

University of Colorado Hospital CRS*, Aurora

80204

Denver Public Health CRS, Denver

85724

University of Arizona CRS, Tucson

90035

UCLA CARE Center CRS*, Los Angeles

90069

Mills Clinical Research CRS, Los Angeles

90073

VA West Los Angeles Medical Center CRS, Los Angeles

90232

Los Angeles LGBT Center CRS, Los Angeles

90502

Harbor-UCLA CRS*, Torrance

92103

UCSD Antiviral Research Center CRS*, San Diego

92264

Eisenhower Health Center at Rimrock CRS, Palm Springs

94110

Ucsf Hiv/Aids Crs*, San Francisco

411001

Byramjee Jeejeebhoy Medical College (BJMC) CRS, Pune

600113

Chennai Antiviral Research and Treatment (CART) CRS, Chennai

69040000

Tropical Medicine Foundation Dr. Heitor Vieira Dourado CRS, Manaus

90033-1079

University of Southern California CRS*, Los Angeles

94304-5350

Stanford AIDS Clinical Trials Unit CRS, Palo Alto

06510

Yale University CRS, New Haven

06516

VA Connecticut Healthcare System CRS, West Haven

30308-2012

The Ponce de Leon Center CRS, Atlanta

02111

Tufts Medical Center CRS, Boston

02114

Massachusetts General Hospital CRS (MGH CRS)*, Boston

02115

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

02118

Boston Medical Center CRS, Boston

01199

Baystate Infectious Diseases Clinical Research CRS, Springfield

63110-1010

Washington University Therapeutics (WT) CRS*, St Louis

08103

Cooper Univ. Hosp. CRS, Camden

07103

New Jersey Medical School Clinical Research Center CRS*, Newark

10032-3732

Columbia P&S CRS*, New York

02906

The Miriam Hospital Clinical Research Site (TMH CRS) CRS*, Providence

75235-9173

UT Southwestern HIV/ID Clinical Trials Unit CRS, Dallas

98104-9929

University of Washington AIDS CRS*, Seattle

Unknown

Gaborone CRS, Gaborone

Joint Clinical Research Centre (JCRC)/Kampala Clinical Research Site, Kampala

Milton Park CRS, Harare

30130-100

School of Medicine, Federal University of Minas Gerais CRS, Belo Horizonte

26030-380

HGNI HIV Family Care Clinic - HHFCC CRS, Nova Iguaçu

91350-200

Hospital Nossa Senhora da Conceicao CRS, Porto Alegre

04121-000

Centro de Referencia e Treinamento DST/AIDS CRS, São Paulo

20020-000

Projeto Praça Onze Pesquisa em Saúde CRS, Rio de Janeiro

20221-903

Hospital Federal dos Servidores do Estado CRS, Rio de Janeiro

21040-360

Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS, Rio de Janeiro

01246-900

Instituto de Infectologia Emilio Ribas CRS, São Paulo

05403-010

Centro de Pesquisas Clínicas IC-HCFMUSP CRS, São Paulo

V6Z 2C7

Vancouver ID Research & Care Centre Society CRS, Vancouver

L8S 1A4

Hamilton Health Sciences - Special Immunology Services Clinic CRS, Hamilton

M5G 1K2

Maple Leaf Research CRS, Toronto

M5G 2N2

Toronto General Hospital CRS, Toronto

H4A 3J1

Chronic Viral Illness Service CRS, Montreal

G1V 4G2

Centre hospitalier de l'Université Laval CRS, Québec

HT-6110

GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS, Port-au-Prince

Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS, Port-au-Prince

32 - 15088

San Miguel CRS, Lima

00935

Puerto Rico AIDS Clinical Trials Unit CRS*, San Juan

03010

Hospital General Universitario de Alicante, Alicante

080916

Hospital Germans Trias i Pujol, Badalona

08003

Hospital Universitario Valle d'Hebron, Barcelona

08036

Hospital Clinic de Barcelona, Barcelona

08907

Hospital Universitario de Bellvitge, Barcelona

03203

Hospital General Universitario De Elche, Elche

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

Kowa Pharmaceuticals America, Inc.

INDUSTRY

collaborator

Gilead Sciences

INDUSTRY

collaborator

Massachusetts General Hospital

OTHER

collaborator

NEAT ID Foundation

OTHER

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH