Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults

PHASE3CompletedINTERVENTIONAL
Enrollment

314

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

August 31, 2012

Study Completion Date

October 31, 2015

Conditions
Acquired Immunodeficiency SyndromeHIV Infections
Interventions
DRUG

COBI

150 mg tablet administered orally with food once daily

DRUG

DRV

800 mg (2 x 400 mg tablets) administered orally with food once daily

DRUG

NRTIs

Participants will receive 2 nucleoside analogue reverse transcriptase inhibitors (NRTIs) selected by the investigator after resistance testing at screening and administered according to prescribing information. NRTIs may include emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF), zidovudine+FTC/TDF, abacavir (ABC)+TDF, ABC+FTC/TDF, ABC+lamivudine (3TC), or didanosine (DDI)+FTC.

Trial Locations (49)

10003

Beth Israel Medical Center, New York

10550

Greiger Clinic, Mount Vernon

11030

North Shore University Hospital / Division of Infectious Diseases, Manhasset

19104

University of PA, Philadelphia

19107

Philadelphia FIGHT, Philadelphia

20009

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

Whitman-Walker Health, Washington D.C.

21093

Johns Hopkins University, Lutherville

22003

Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID), Annandale

27157

Wake Forest University Health Services, Winston-Salem

27710

Duke University Medical Center, Durham

28079

Carolinas Medical Center-Myer's Park Infectious Disease Clinic, Charlotte

30033

Infectious Disease Specialists of Atlanta, Decatur

30309

Atlanta ID group, Atlanta

31220

Mercer University, Macon

32803

Orlando Immunology Center, 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

34983

Midway Immunology and Research Center, Ft. Pierce

48072

Be Well Medical Center, Berkley

48202

Henry Ford Hospital, Detroit

55415

HIV Program Hennepin County Medical Center, Minneapolis

60613

Howard Brown Health Center, Chicago

60657

Northstar Medical Center, Chicago

63108

Central West Clinical Research Inc, Saint Louis

75208

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

75219

Southwest Infectious Disease Clinical Research, Inc., Dallas

75605

DCOL Center for Clinical Research, Longview

76104

Tarrant County Infectious Disease, Fort Worth

77004

Therapeutic Concepts, PA, Houston

77098

Gordon Crofoot MD, PA, Houston

78705

Central Texas Clinical Research, Austin

80220

Apex Research LLC, Denver

85012

Spectrum Medical Group, Phoenix

89104

Swedish Medical Center, Seattle

90036

Peter J Ruane MD Inc., Los Angeles

90069

Anthony Mills MD Inc, Los Angeles

90813

Long Beach Education and Research Consultants, PC, Long Beach

92103

La Playa Medical Group and Clinical Research, San Diego

94109

Metropolis Medical, San Francisco

94304

Stanford University, Palo Alto

95825

Kaiser Permanente Medical Group, Sacramento

96816

Hawaii Center for AIDS, University of Hawaii, Honolulu

02215

Community Research Initiative of New England, Boston

07102

Saint Michael's Medical Center, Newark

08244

South Jersey Infectious Disease, Somers Point

02906

Miriam Hospital, Providence

00909

Clinical Research Puerto Rico, San Juan

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Janssen Research & Development, LLC

INDUSTRY

lead

Gilead Sciences

INDUSTRY