Safety and Efficacy of E/C/F/TDF Versus RTV-Boosted ATV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment-Naive Women

PHASE3CompletedINTERVENTIONAL
Enrollment

583

Participants

Timeline

Start Date

October 24, 2012

Primary Completion Date

February 9, 2015

Study Completion Date

September 6, 2018

Conditions
Acquired Immunodeficiency SyndromeHIV Infections
Interventions
DRUG

E/C/F/TDF

150/150/200/300 mg FDC tablet administered orally with food once daily

DRUG

ATV

300 mg capsule administered orally with food once daily

DRUG

RTV

100 mg tablet administered orally with food once daily

DRUG

FTC/TDF

200/300 mg tablet administered orally with food once daily

DRUG

E/C/F/TDF Placebo

Tablet administered orally with food once daily

DRUG

ATV Placebo

Tablet administered orally with food once daily

DRUG

RTV Placebo

Capsule administered orally with food once daily

DRUG

FTC/TDF Placebo

Tablet administered orally with food once daily

DRUG

E/C/F/TAF

150/150/200/10 mg FDC tablet administered orally with food once daily

Trial Locations (99)

1000

Saint-Pierre University Hospital, Brussels

1050

Hôpitaux IRIS SUD, Brussels

2000

Institute of Tropical Medicine, Antwerp

10040

Montefiore Medical Center, The Bronx

10330

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Bangkok

10400

Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok

10514

Instituto Dominicano de Estudio Virologicos - IDEV, Santo Domingo

Salvador B Gautier Hospital, Infectious Diseases Department, Santo Domingo

10700

Department of Preventive and Social Medicine, Faculty of Medicine, Siriraj Hospital, Bangkok

11000

Bamrasnaradura lnfectious Disease Institute, Nonthaburi

14000

Intituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City

14642

University of Rochester, Rochester

18102

Lehigh Valley Health Network, Allentown

19107

Philadelphia FIGHT, Philadelphia

Thomas Jefferson University, Philadelphia

19140

Temple University Hospital- Internal General Medicine, Philadelphia

20009

Whitman-Walker Health, Washington D.C.

20037

George Washington University Medical Faculty Associates, Washington D.C.

20142

Department of Health Sciences - University of Milan - San Paolo Hospital, Milan

20157

Luigi Sacco Hospital, Milan, Milan

27157

Wake Forest University Health Sciences, Winston-Salem

27599

University of North Carolina AIDS Clinical Trials Unit, Chapel Hill

27710

Duke University Medical Center, Durham

27834

East Carolina University The Brody School of Medicine Div. of Infectious Diseases, Greenville

29425

Medical University of South Carolina, Charleston

30033

Infectious Disease Specialists of Atlanta, Decatur

30308

AIDS Research Consortium of Atlanta, Atlanta

Emory HIV/AIDS Clinical Trials Unit, Atlanta

31201

Mercer University Mercer Medicine, Macon

31401

Chatham County Health Daprtment, Savannah

32803

Orlando Immunology Center, Orlando

32806

IDOCF/ValuhealthMD, Orlando

33136

University of Miami, Miami

33401

Triple O Research Institute, P.A., West Palm Beach

33614

St. Joseph's Hospital Comprehensive Research Institute, Tampa

34982

Midway Immunology and Research Center, Ft. Pierce

40202

University of Louisville, Louisville

41124

Clinica Malattie Infettive, Azienda Ospedaliero Universitaria, Modena

43210

Wexner Medical Center at the Ohio State University, Columbus

43614

The University of Toledo Medical Center, Toledo

44280

Hospital Civil de Guadalajara, Guadalajara

44340

Hospital Civil de Guadalajara Dr Juan I Menchaca, Guadalajara

50200

Chiang Mai University, Chiang Mai

67091

Hopitaux Universitaires Strasbourg, Strasbourg

70119

LSUHSC HIV Out-Patient Clinic Research, New Orleans

75018

Hôpital Bichat Claude Bernard, Paris

75020

Hopital Tenon, Paris

75208

AIDS Arms, Inc./Trinity Health & Wellness Center, Dallas

North Texas Infectious Diseases Consultants, PA, Dallas

75651

Maladies Infectieuses Dpt, Paris

77004

Therapeutic Concepts, PA, Houston

77401

UT - Physicians, Bellaire

78705

Central Texas Clinical Research, Austin

90033

University of Southern California AIDS Clinical Trials Group, Los Angeles

95817

University of California, Davis Medical Center, Sacramento

105275

Infectious Hospital 2, Moscow

State Healthcare Institution Infectious Clinical Hospital #2 of Moscow City Healthcare Department, Moscow

129110

"GKUZ MO Center for Prevention and Treatment of AIDS and Infectious Diseases (Moscow Regional AIDS Center)", Moscow

190020

St.Petersburg Center for Prevention and Control of AIDS and Infectious Diseases, In-patient Department, Saint Petersburg

190103

"St.Petersburg GUZ Center for Prevention and Control of AIDS and Infectious Diseases, Out-patient Department", Saint Petersburg

191167

"Saint-Petersburg GUZ Clinical Infectious Hospital named after S.P.Botkin", Saint Petersburg

196645

"Federal State Budgetary Institution Republic Clinical Infectious Hospital", Saint Petersburg

302040

"Budgetary Medical Facility of the Orel Region Orel Regional Center for Prevention and Control of AIDS and Infectious Diseases", Oryol

350015

"State Budget Healthcare Institution Clinical Centre for AIDS and Infectious Diseases Fight and Prevention of Krasnodar regio Department for Healthcare", Krasnodar

394065

"GUZ Voronezh Regional Center for Prevention and Control of AIDS and Infectious Diseases", Voronezh

398043

"GUZ Lipetsk Regional Center for Prevention and Control of AIDS and Infectious Diseases", Lipetsk

400040

Volgograd Regional Center for Prevention and Control of AIDS and Infectious Diseases, Volgograd

410009

Saratov Regional Centre for Treatment and Prevention of AIDS and Infectious Diseases, Saratov

603950

"State Budget Health Institution of Nizhniy Novgorod Nizhniy Novgorod Regional Center of prophylaxis and treatment of AIDS and Infectious Diseases", Nizhny Novgorod

614000

Perm Regional Center for Prevention and Control of AIDS and Infectious Diseases, Perm

620102

Sverdlovsk Regional Center for Prevention and control of AIDS and Infectious Diseases, Yekaterinburg

630559

"Infectious Diseases Center, LLC", Koltsovo

656010

Republic of Altay Center for Prevention and Control of AIDS and Infectious Diseases, Barnaul

660049

"GUZ Krasnoyarsk Territorial Center for Prevention and Control of AIDS and Infectious Diseases", Krasnoyarsk

664043

"GUZ Irkutsk Regional Center for Prevention and Control of AIDS and Infectious Diseases", Irkutsk

680031

Khabarovsk Territorial Center for Prevention and Control of AIDS and Infectious Diseases, Khabarovsk

02115

Brigham and Women's Hospital, Boston

01105

The Research Institute, Springfield

07102

Saint Michael's Medical Center, Newark

07103

New Jersey Medical School, Newark

01135

New York Hospital Queens, Flushing

02906

The Miriam Hospital, Providence

2720-276

Hospital Fernando Fonseca, Amadora

1200-110

Hospital Dos Capuchos, Centro Hospitalar De Lisboa Central, Lisbon

1649-035

Hospital de Santa Maria - Serviço de Doenças Infecciosas, Lisbon

4200-319

centro Hospitalar S. João, Porto

4369-004

Centro Hospitalar do Porto - Hospital Joaquim Urbano, Porto

2005-177

Hospital de Santarém, Santarém

00936

Maternal Infants Studies Center (CEMI), San Juan

Unknown

Joint Clinical Research Centre, Kampala

E11BB

Barts Healthe NHS Trust, London

E96SR

Homerton University Hospital NHS Foundation Trust, London

NW32QG

Royal Free London NHS Foundation Trust, London

SE18 4QH

Queen Elizabeth Hospital, South London Healthcare NHS Trust, London

SE59RJ

Kings College London, London

SW17 0QT

St George's Healthcare NHS Trust, London

W21NY

Imperial College Healthcare NHS Trust, London

WC1E 6JB

Mortimer Market Centre and Central and North West London NHS Foundation Trust, London

RG1 5LE

Royal Berkshire NHS Foundation Trust, Reading

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

NCT01705574 - Safety and Efficacy of E/C/F/TDF Versus RTV-Boosted ATV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment-Naive Women | Biotech Hunter | Biotech Hunter