D/C/F/TAF Versus COBI-boosted DRV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment Naive Adults

PHASE2CompletedINTERVENTIONAL
Enrollment

153

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

January 31, 2013

Study Completion Date

February 28, 2014

Conditions
Acquired Immunodeficiency SyndromeHIV Infections
Interventions
DRUG

D/C/F/TAF

DRV 800 mg/COBI 150 mg/FTC 200 mg/TAF 10 mg FDC tablet administered orally once daily

DRUG

DRV

DRV 800 mg (2 × 400 mg tablets) administered orally once daily

DRUG

COBI

COBI 150 mg tablet administered orally once daily

DRUG

FTC/TDF

FTC 200 mg/TDF 300 mg FDC tablet administered orally once daily

DRUG

D/C/F/TAF Placebo

D/C/F/TAF placebo tablet administered orally once daily

DRUG

DRV Placebo

DRV placebo tablet administered orally once daily

DRUG

COBI Placebo

COBI placebo tablet administered orally once daily

DRUG

FTC/TDF Placebo

FTC/TDF placebo tablet administered orally once daily

Trial Locations (44)

10011

Weill Cornell Medical College, New York

11030

North Shore University Hospital / Division of Infectious Diseases, Manhasset

20009

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

Whitman-Walker Health, Washington D.C.

20036

Capital Medical Associates, PC, Washington D.C.

22003

CARE-ID, Annandale

27710

Duke University Medical Center, Durham

28209

ID Consultants, P.A., Charlotte

29203

University of South Carolina School of Medicine Division of Infectious Disease, Columbia

30033

Infectious Disease Specialists of Atlanta, Decatur

31201

Mercer University Mercer Medicine, Macon

32803

Orlando Immunology Center, Orlando

32806

IDOCF/ValuhealthMD, LLC, Orlando

33139

Wohlfeiler, Piperato and Associates, LLC, Miami Beach

33316

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

33614

St. Joseph's Comprehensive Research Institute, Tampa

35294

University of Alabama at Birmingham, Birmingham

48072

Be Well Medical Center, Berkley

48202

Henry Ford Health System, Detroit

55415

Hennepin County Medical Center, Minneapolis

60613

Howard Brown Health Center, Chicago

63108

Central West Clinical Research Inc, St Louis

75219

Southwest Infectious Disease Clinical Research Inc, Dallas

75605

DCOL Center for Clinical Research, Longview

76104

Tarrant County Infectious Disease Associates, Fort Worth

77004

Therapeutic Concepts, PA, Houston

77098

Gordon E. Crofoot, MD., PA, Houston

80209

Apex Research, Denver

80220

Denver Infectious Disease Consultants, PLLC, Denver

90027

Kaiser Permanente, Los Angeles

90036

Peter J. Ruane, MD, Inc., Los Angeles

90069

Anthony Mills MD, Inc, Los Angeles

90211

AHF Research Center, Beverly Hills

92103

La Playa Medical Group and Clinical Research, San Diego

92663

Orange Coast Medical Group, Newport Beach

94118

Kasier Permanente Medical Center, San Francisco

TPMG--Clinical Trials Unit, San Francisco

94304

Stanford University, Palo Alto

94609

Alta Bates Summit Medical Center, East Bay AIDS Center, Oakland

95825

Kaiser Permanente Medical Group, Sacramento

98104

Peter Shalit, M.D., Seattle

02115

Brigham and Women's Hospital, Boston

02215

Community Research Initiative (CRI), Boston

00909

Clinical Research Puerto Rico, San Juan

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY