Safety and Efficacy of Cobicistat-boosted Atazanavir Compared to Ritonavir-boosted Atazanavir in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

PHASE2CompletedINTERVENTIONAL
Enrollment

85

Participants

Timeline

Start Date

May 31, 2009

Primary Completion Date

December 31, 2009

Study Completion Date

January 31, 2015

Conditions
HIV-1 Infection
Interventions
DRUG

COBI

Cobicistat (COBI) 150 mg tablet administered orally once daily

DRUG

RTV

Ritonavir (RTV) 100 mg soft gelatin capsule administered orally once daily

DRUG

ATV

Atazanavir (ATV) 300 mg capsule administered orally once daily

DRUG

FTC/TDF

Emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination tablet administered orally once daily

DRUG

COBI placebo

Placebo to match COBI administered orally once daily

DRUG

RTV placebo

Placebo to match RTV administered orally once daily

Trial Locations (31)

20009

Dupont Circle Physicians Group, Washington D.C.

Whitman Walker Clinic, Washington D.C.

20036

Capital Medical Associates PC, Washington D.C.

21201

Chase Brexton Health Services, Inc., Baltimore

28078

Rosedale Infectious Diseases, Huntersville

30033

Infectious Disease Specialists of Atlanta (IDSA), Decatur

30308

AIDS Research Consortium of Atlanta, Atlanta

32806

ValuehealthMD, LLC, Orlando

33139

Wohlfeiler, Piperato and Associates, LLC, Miami Beach

33316

Gary Richmond, MD, PA, Inc., Fort Lauderdale

33614

St. Joseph's Comprehensive Research Institute, Tampa

48072

Be Well Medical Center, Berkley

60657

Northstar Medical Center, Chicago

63108

Central West Healthcare, St Louis

63139

Southampton Healthcare, Inc., St Louis

72207

Health for Life Clinic, PLLC, Little Rock

75204

Nicholaos Bellos, MD, PA, Dallas

75215

AIDS Arms/ Peabody Health Center, Dallas

77098

Gordon E. Crofoot, MD, PA, Houston

77478

Therapeutic Concepts, P.A., Houston

80220

Denver Infectious Disease Consultants, PLLC, Denver

85006

Southwest Center for HIV/AIDS, Phoenix

87505

Southwest C.A.R.E. Center, Santa Fe

90036

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

90804

AIDS Healthcare Foundation-Research Center, Beverly Hills

90813

The Living Hope Foundation, Long Beach

92103

David J. Shamblaw, MD Inc., San Diego

92663

Orange Coast Medical Group, Newport Beach

94115

Metropolis Medical, San Francisco

98103

TribalMed, Seattle

07102

Saint Michael's Medical Center, Newark

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

NCT00892437 - Safety and Efficacy of Cobicistat-boosted Atazanavir Compared to Ritonavir-boosted Atazanavir in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults | Biotech Hunter | Biotech Hunter