Switch Study to Evaluate F/TAF in HIV-1 Positive Participants Who Are Virologically Suppressed on Regimens Containing FTC/TDF

PHASE3CompletedINTERVENTIONAL
Enrollment

668

Participants

Timeline

Start Date

May 6, 2014

Primary Completion Date

August 12, 2015

Study Completion Date

March 1, 2019

Conditions
HIV-1 Infection
Interventions
DRUG

FTC/TDF

200/300 mg FDC tablets administered orally once daily

DRUG

F/TAF

Tablets administered orally once daily

DRUG

Allowed third antiretroviral agent

An allowed third antiretroviral agent of the participant's pre-existing regimen may include one of the following: ritonavir-boosted atazanavir (ATV/r), ritonavir-boosted lopinavir (LPV/r), ritonavir-boosted darunavir (DRV/r), efavirenz (EFV; Sustiva®), rilpivirine (RPV; Edurant®), nevirapine (NVP;Viramune®), raltegravir (RAL; Isentress®), dolutegravir (DTG;Tivicay®), and maraviroc (MVC; Selzentry®).

DRUG

FTC/TDF Placebo

Tablets administered orally once daily

DRUG

F/TAF Placebo

Tablets administered orally once daily

Trial Locations (78)

1000

CHU Saint-Pierre of Brussels, Brussels

10011

Ricky K. Hsu, MD, PC, New York

10461

Jacobi Medical Center, The Bronx

10467

Montefiore Medical Center, The Bronx

11030

North Shore University Hospital, Manhasset

11355

New York Hospital Queens, Flushing

20009

Dupont Circle Physician's Group, Washington D.C.

Whitman-Walker Health, Washington D.C.

20036

Capital Medical Associates, Washington D.C.

20037

Medical Faculty Associates, Washington D.C.

20127

IRCCS Ospedale San Raffaele, Centro San Luigi, Milan

24127

Azienda Ospedaliera Papa Giovanni XXIII, Bergamo

28209

Infectious Disease Consultants, PA, Charlotte

30309

Atlanta ID Group, Atlanta

30312

AIDS Research Consortium of Atlanta, Atlanta

31201

Mercer University School of Medicine, Macon

32803

Orlando Immunology Center, Orlando

32960

AIDS Research & Treatment Center of the Treasure Coast, Vero Beach

33133

Tarrant County Infectious Disease Associates, Miami

33139

AIDS Healthcare Foundation, Miami Beach

33308

TheraFirst Medical Center, Fort Lauderdale

33316

Gary J. Richmond,M.D.,P.A., Fort Lauderdale

33401

Triple O Research Institute PA, West Palm Beach

33602

AIDS Healthcare Foundation, Tampa

34295

University Hospital of Montpellier (CHU-Gui de Chauliac), Montpellier

34982

Midway Immunology and Research Center, Ft. Pierce

35294

University of Alabama at Birmingham, Birmingham

43210

Ohio State University Medical Center, Columbus

44093

CHU de Nantes Hopital de l'Hotel Dieu, Nantes

48072

Be Well Medical Center, Berkley

53226

Medical College of Wisconsin, Milwaukee

55415

Hennepin County Medical Center, Minneapolis

59208

Centre Hospitalier de Tourcoing, Tourcoing

63110

St. Louis University, St Louis

63139

Southampton Healthcare, Inc., St Louis

64111

The Kc Care Clinic Site 5580, Kansas City

75018

Hopital Bichat Claude Bernard, Paris

75020

Hôpital Tenon, Paris

75215

AIDS Arms, Inc, Dallas

75219

Southwest Infectious Disease Clinical Research, Inc, Dallas

75246

North Texas Infectious Diseases Consulants, Dallas

76104

AIDS Arms, Inc./Trinity Health & Wellness Center, Fort Worth

77004

Therapeutic Concepts, PA, Houston

77098

Gordon E. Crofoot MD PA, Houston

78705

Central Texas Clinical Research, Austin

80205

Kaiser Permanente Colorado, Denver

80206

National Jewish Health, Denver

80209

Apex Research LLC, Denver

85012

Spectrum Medical Group, Phoenix

87505

Southwest CARE Center, Santa Fe

90036

Tarrant County ID Associates, Los Angeles

90069

Southern California Men's Medical Group, Los Angeles

90211

Pacific Oaks Medical Group, Beverly Hills

90502

Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance

92103

La Playa Medical Group and Clinical Research, San Diego

94118

Kaiser Permanente Medical Group San Francisco, San Francisco

94545

Kaiser Permanente, Hayward

94602

Highland Hospital - Alameda Health System (formerly Alameda County medical Center), Oakland

95825

Kaiser Permanente Sacramento Medical Center, Sacramento

98104

Peter Shalit, MD, Seattle

99202

Premier Clinical Research, Spokane

02111

Community Research Initiative of New England, Boston

02115

Brigham and Women's Hospital, Boston

07102

Prime Healthcare Services - St Michael's LLC d/b/a Saint Michael's Medical Center, Newark

08244

South Jersey Infectious Disease, Somers Point

V6Z 2C7

Vancouver Infectious Disease Research and Care Centre, Vancouver

K1Y 4E9

Ottawa Hospital-General Campus, Ottawa

M5B 1L6

Maple Leaf Medical Clinic/Maple Leaf Research, Toronto

M5G 2N2

University Health Network/Toronto General Hospital, Toronto

00901

Hope Clinical Research, San Juan

00909

Clinical Research Puerto Rico Inc, San Juan

00935

University of Puerto Rico School of Medicine, San Juan

BN2 1ES

Brighton and Sussex University Hospitals, Brighton

E1 1BB

Barts Health NHS Trust, London

NW3 2QG

Royal Free London NHS Foundation Trust, London

SE5 9RJ

King's College Hospital, London

SW10 9TH

Chelsea and Westminster Hospital, London

M13 0FH

Manchester Centre for Sexual Health, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY