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Safety and Efficacy of COBI-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

Primary Purpose

HIV, HIV Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
COBI
RTV
ATV
FTC/TDF
COBI placebo
RTV placebo
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV focused on measuring Treatment Naive, HIV 1 Infected

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
  • Plasma HIV-1 RNA levels ≥ 5,000 copies/mL at screening
  • No prior use of any approved or investigational antiretroviral drug for any length of time
  • Screening genotype report must show sensitivity to FTC, TDF and ATV
  • Normal ECG
  • Adequate renal function (eGFR calculated using the Cockcroft-Gault equation ≥ 70 mL/min)
  • Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
  • Adequate hematologic function
  • Serum amylase ≤ 5 x ULN
  • Males and females of childbearing potential must agree to utilize highly effective contraception methods from screening throughout the duration of study treatment and for 30 days following the last dose of study drug.
  • Age ≥ 18 years
  • Life expectancy ≥ 1 year

Exclusion Criteria:

  • A new AIDS-defining condition diagnosed within the 30 days prior to screening
  • Receiving drug treatment for Hepatitis C, or anticipated to receive treatment for Hepatitis C
  • Subjects experiencing decompensated cirrhosis
  • Females who are breastfeeding
  • Positive serum pregnancy test (female of childbearing potential)
  • Have an implanted defibrillator or pacemaker
  • Have an ECG PR interval ≥ 220 msec
  • Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance.
  • A history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma.
  • Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline.
  • Medications contraindicated for use with COBI, emtricitabine (FTC), tenofovir disoproxil fumarate (TDF), atazanavir (ATV), ritonavir (RTV) or subjects with any known allergies to the excipients of COBI tablets, Truvada tablets, atazanavir capsules or ritonavir tablets.
  • Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial.
  • Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements.

Sites / Locations

  • University of Alabama at Birmingham
  • Spectrum Medical Group
  • Health for Life Clinic PLLC
  • Living Hope Clinical Foundation
  • Kaiser Permanente
  • Los Angeles Gay and Lesbian Center DBA Jeffrey Goodman Special Care Clinic
  • Peter J Ruane, MD, Inc
  • Oasis Clinic
  • Anthony Mills MD Inc
  • University of California, Davis Medical Center
  • Kaiser Permanente Medical Group
  • La Playa Medical Group and Clinical Research
  • Metropolis Medical
  • Kaiser Permanente Medical Center, Clinical Trials Unit
  • Apex Research, LLC
  • Dupont Circle Physicians Group
  • Whitman-Walker Clinic
  • George Washington University Medical Faculty Associates
  • Therafirst Medical Center
  • Broward Health/Comprehensive Care Center
  • Midway Immunology and Research Center
  • Wohlfeiler, Piperato and Associates, LLC
  • The Kinder Medical Group
  • University of Miami School of Medicine
  • Orlando Immunology Center
  • Idocf/ Valuhealthmd, Llc
  • University of South Florida HIV Clinical Research Unit / Hillsborough County Health Department
  • Infectious Disease Research Institute Inc.
  • St. Joseph's Comprehensive Research Institute
  • Infectious Disease Specialists of Atlanta
  • Mercer University School of Medicine
  • Howard Brown Health Center
  • Johns Hopkins University School of Medicine
  • Community Research Initiative of New England
  • Be Well Medical Center
  • Henry Ford Health System
  • Hennepin County Medical Center
  • CentralWest Clinical Research
  • Saint Michaels Medical Center
  • South Jersey Infectious Disease
  • SouthWest CARE Center
  • Montefiore Medical Center - AIDS Center
  • North Shore University Hospital
  • Chelsea Village Medical, PC
  • Mt Sinai School of Medicine
  • Ricky K. Hsu, MD, PC
  • Carolinas Medical Center-Myers Park
  • Duke University Medical Center
  • East Carolina University, The Brody School of Medicine
  • Rosedale Infectious Diseases
  • Wake Forest University Health Sciences
  • University of Pennsylvania
  • Division of Infectious Diseases, Thomas Jefferson University
  • Philadelphia FIGHT
  • University of South Carolina
  • Southwest Infectious Disease Clinical Research, Inc.
  • Tarrant County Infectious Disease Associates
  • Garcia's Family Health Group
  • Therapeutic Concepts, PA
  • Gordon E. Crofoot MD PA
  • Research Access Network
  • DCOL Center for Clinical Research
  • Peter Shalit, M.D.
  • Medical College of Wisconsin
  • St Vincent's Hospital, Sydney
  • Taylor Square Private Clinic
  • Albion Street Centre
  • Holdsworth House Medical practice
  • Melbourne Sexual Health Centre
  • Alfred Hospital
  • Northside Clinic
  • LKH Graz West
  • Allgemeines Krankenhaus
  • Interne Lungenabteilung, SMZ Baumgartner Hoehe - Otto-Wagner-Spital
  • CHU Saint-Pierre University Hospital
  • Hôpital Universitaire Erasme - ULB
  • University of Ghent
  • Instituto De Pesquisa Clinica Evandro Chagas
  • URDIP Faculdade de Medicina do ABC
  • Universidade Estadual de Campinas
  • Instituto De Infectologia Emilo Ribas
  • Brasilmed Assistencia Medica E Pesquisas
  • Crt-Dst/Aids
  • Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg
  • Canadian Immunodeficiency Research Collaborative (CIRC) Inc.
  • University Health Network, Toronto General Hospital
  • Clinique medicale l'Actuel
  • Clinique Medicale du Quartier Latin
  • Immunodeficiency Service, McGill University Health Centre (MUHC) - Montreal Chest Institute
  • Project LORI
  • Rigshospitalet, Infektionsklinik 5112
  • Instituto Dominicano de Estudios Virologicos - IDEV
  • Service des Maladies Infectieuses, CHU de Caen
  • Hôpital de la Croix Rousse - Maladies Infectieuses et Tropicales
  • Hopital Sainte Marguerite Service d'Immuno-Hématologie Clinique -CISIH
  • CHU de Nantes Hopital de l'Hotel Dieu
  • Department of Infectious Diseases, Saint-Louis hospital
  • Hopital Saint Antoine, Service De Maladies Infectieuses
  • Bichat Hospital
  • Tenon Hospital, UPMC
  • Maladies Infectieuses Dpt
  • Centre François Magendie, Hôpital du Haut Lévêque
  • Centre Hospitalier de Tourcoing
  • EPIMED GmbH
  • Medizinische Universitätsklinik
  • Infektio Research GmbH / Infektiologikum Frankfurt
  • ICH Study Center Hamburg
  • University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit
  • University of Cologne, Department of Internal Medicine
  • Azienda Ospedaliera Luigi Sacco 1° Divisione Malattie Infettive
  • Fondazione Centro San Raffaele del Monte Tabor
  • Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
  • Dipartimento di Malattie Infettive
  • Unidad de VIH, Hospital Civil de Guadalajara, Fray Antonio Alcalde
  • Onze lieve vrouw gasthuis
  • Hospital de Santa Maria - CHLN
  • Serviço de Doenças Infecciosas, Hospital de São João
  • Instituto de Investigacion Clentifica del Sur
  • Clinical Research Puerto Rico
  • Hospital General Universitario Gregorio Marañon
  • Hospital Virgen del Rocio
  • CHUV
  • Universitätsklinik für Infektiologie, Universitätsspital Bern
  • Division of Infectious Diseases and Hospital Hygiene; University Hospital of Zurich
  • HIV-NAT, Thai Red Cross AIDS Research Center and Faculty of Medicine Chulalongkorn University
  • Ramathibodi Hospital, Mahidol University
  • Siriraj Hospital
  • Maharaj Nakorn Chiang Mai University, Faculty of Medicine, Department of Medicine
  • Khon Kaen University
  • Brighton and Sussex University Hospitals NHS Trust
  • Barts and the London NHS Trust
  • Homerton University Hospital
  • Guys and St. Thomas' NHS Trust
  • Courtyard Clinic, St. Georges Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ATV+COBI+FTC/TDF

ATV+RTV+FTC/TDF

Arm Description

COBI + RTV placebo + ATV + FTC/TDF once daily

RTV + COBI placebo + ATV + FTC/TDF once daily

Outcomes

Primary Outcome Measures

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the prespecified time point within an allowed window of time, along with study drug discontinuation status.

Secondary Outcome Measures

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 144 was analyzed using the snapshot algorithm.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 192
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 192 was analyzed using the snapshot algorithm.
Change From Baseline in CD4 Cell Count at Week 48
Change From Baseline in CD4 Cell Count at Week 96
Change From Baseline in CD4 Cell Count at Week 144
Change From Baseline in CD4 Cell Count at Week 192

Full Information

First Posted
April 20, 2010
Last Updated
April 15, 2016
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01108510
Brief Title
Safety and Efficacy of COBI-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Official Title
A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9350-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this study is to evaluate the safety and efficacy of a regimen containing cobicistat-boosted atazanavir (ATV+COBI) plus emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF) fixed-dose combination (FDC) versus ritonavir-boosted atazanavir (ATV+RTV) plus FTC/TDF FDC in HIV-1 infected, antiretroviral treatment-naive adults. Participants will be randomized in a 1:1 ratio. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL) at screening.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, HIV Infections
Keywords
Treatment Naive, HIV 1 Infected

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
698 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ATV+COBI+FTC/TDF
Arm Type
Experimental
Arm Description
COBI + RTV placebo + ATV + FTC/TDF once daily
Arm Title
ATV+RTV+FTC/TDF
Arm Type
Active Comparator
Arm Description
RTV + COBI placebo + ATV + FTC/TDF once daily
Intervention Type
Drug
Intervention Name(s)
COBI
Other Intervention Name(s)
Tybost®, GS-9350
Intervention Description
Cobicistat (COBI) 150 mg tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
RTV
Other Intervention Name(s)
Norvir®
Intervention Description
Ritonavir (RTV) 100 mg tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
ATV
Other Intervention Name(s)
Reyataz®
Intervention Description
Atazanavir (ATV) 300 mg capsule administered orally once daily
Intervention Type
Drug
Intervention Name(s)
FTC/TDF
Other Intervention Name(s)
Truvada®
Intervention Description
Emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
COBI placebo
Intervention Description
Placebo to match COBI administered orally once daily
Intervention Type
Drug
Intervention Name(s)
RTV placebo
Intervention Description
Placebo to match RTV administered orally once daily
Primary Outcome Measure Information:
Title
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
Description
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the prespecified time point within an allowed window of time, along with study drug discontinuation status.
Time Frame
Week 48
Secondary Outcome Measure Information:
Title
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
Description
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm.
Time Frame
Week 96
Title
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144
Description
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 144 was analyzed using the snapshot algorithm.
Time Frame
Week 144
Title
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 192
Description
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 192 was analyzed using the snapshot algorithm.
Time Frame
Week 192
Title
Change From Baseline in CD4 Cell Count at Week 48
Time Frame
Baseline to Week 48
Title
Change From Baseline in CD4 Cell Count at Week 96
Time Frame
Baseline to Week 96
Title
Change From Baseline in CD4 Cell Count at Week 144
Time Frame
Baseline to Week 144
Title
Change From Baseline in CD4 Cell Count at Week 192
Time Frame
Baseline to Week 192

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures Plasma HIV-1 RNA levels ≥ 5,000 copies/mL at screening No prior use of any approved or investigational antiretroviral drug for any length of time Screening genotype report must show sensitivity to FTC, TDF and ATV Normal ECG Adequate renal function (eGFR calculated using the Cockcroft-Gault equation ≥ 70 mL/min) Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN) Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin Adequate hematologic function Serum amylase ≤ 5 x ULN Males and females of childbearing potential must agree to utilize highly effective contraception methods from screening throughout the duration of study treatment and for 30 days following the last dose of study drug. Age ≥ 18 years Life expectancy ≥ 1 year Exclusion Criteria: A new AIDS-defining condition diagnosed within the 30 days prior to screening Receiving drug treatment for Hepatitis C, or anticipated to receive treatment for Hepatitis C Subjects experiencing decompensated cirrhosis Females who are breastfeeding Positive serum pregnancy test (female of childbearing potential) Have an implanted defibrillator or pacemaker Have an ECG PR interval ≥ 220 msec Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance. A history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline. Medications contraindicated for use with COBI, emtricitabine (FTC), tenofovir disoproxil fumarate (TDF), atazanavir (ATV), ritonavir (RTV) or subjects with any known allergies to the excipients of COBI tablets, Truvada tablets, atazanavir capsules or ritonavir tablets. Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial. Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huyen Cao, MD
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Spectrum Medical Group
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Health for Life Clinic PLLC
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72207
Country
United States
Facility Name
Living Hope Clinical Foundation
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Kaiser Permanente
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Los Angeles Gay and Lesbian Center DBA Jeffrey Goodman Special Care Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90028
Country
United States
Facility Name
Peter J Ruane, MD, Inc
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Oasis Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90059
Country
United States
Facility Name
Anthony Mills MD Inc
City
Los Angeles
State/Province
California
ZIP/Postal Code
90069
Country
United States
Facility Name
University of California, Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Kaiser Permanente Medical Group
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
La Playa Medical Group and Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Metropolis Medical
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Kaiser Permanente Medical Center, Clinical Trials Unit
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Apex Research, LLC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Dupont Circle Physicians Group
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20009
Country
United States
Facility Name
Whitman-Walker Clinic
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20009
Country
United States
Facility Name
George Washington University Medical Faculty Associates
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Therafirst Medical Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Broward Health/Comprehensive Care Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33311
Country
United States
Facility Name
Midway Immunology and Research Center
City
Fort Pierce
State/Province
Florida
ZIP/Postal Code
34982
Country
United States
Facility Name
Wohlfeiler, Piperato and Associates, LLC
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33139
Country
United States
Facility Name
The Kinder Medical Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
University of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Orlando Immunology Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Idocf/ Valuhealthmd, Llc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
University of South Florida HIV Clinical Research Unit / Hillsborough County Health Department
City
Tampa
State/Province
Florida
ZIP/Postal Code
33602
Country
United States
Facility Name
Infectious Disease Research Institute Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
St. Joseph's Comprehensive Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Facility Name
Infectious Disease Specialists of Atlanta
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Mercer University School of Medicine
City
Macon
State/Province
Georgia
ZIP/Postal Code
31210
Country
United States
Facility Name
Howard Brown Health Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60613
Country
United States
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Community Research Initiative of New England
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Be Well Medical Center
City
Berkley
State/Province
Michigan
ZIP/Postal Code
48072
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
CentralWest Clinical Research
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Saint Michaels Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Facility Name
South Jersey Infectious Disease
City
Somers Point
State/Province
New Jersey
ZIP/Postal Code
08244
Country
United States
Facility Name
SouthWest CARE Center
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
Facility Name
Montefiore Medical Center - AIDS Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Chelsea Village Medical, PC
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Mt Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Ricky K. Hsu, MD, PC
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Carolinas Medical Center-Myers Park
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
East Carolina University, The Brody School of Medicine
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Rosedale Infectious Diseases
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Division of Infectious Diseases, Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Philadelphia FIGHT
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Southwest Infectious Disease Clinical Research, Inc.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75204
Country
United States
Facility Name
Tarrant County Infectious Disease Associates
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Garcia's Family Health Group
City
Harlingen
State/Province
Texas
ZIP/Postal Code
78550
Country
United States
Facility Name
Therapeutic Concepts, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Gordon E. Crofoot MD PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Facility Name
Research Access Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Facility Name
DCOL Center for Clinical Research
City
Longview
State/Province
Texas
ZIP/Postal Code
75605
Country
United States
Facility Name
Peter Shalit, M.D.
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
St Vincent's Hospital, Sydney
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Taylor Square Private Clinic
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Albion Street Centre
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Holdsworth House Medical practice
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Melbourne Sexual Health Centre
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Northside Clinic
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3068
Country
Australia
Facility Name
LKH Graz West
City
Graz
ZIP/Postal Code
A-8010
Country
Austria
Facility Name
Allgemeines Krankenhaus
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Interne Lungenabteilung, SMZ Baumgartner Hoehe - Otto-Wagner-Spital
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Facility Name
CHU Saint-Pierre University Hospital
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Hôpital Universitaire Erasme - ULB
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
University of Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Instituto De Pesquisa Clinica Evandro Chagas
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
21040-900
Country
Brazil
Facility Name
URDIP Faculdade de Medicina do ABC
City
Santo Andre
State/Province
Sao Paulo
ZIP/Postal Code
09060-650
Country
Brazil
Facility Name
Universidade Estadual de Campinas
City
Campinas
ZIP/Postal Code
13083-970
Country
Brazil
Facility Name
Instituto De Infectologia Emilo Ribas
City
São Paulo
ZIP/Postal Code
01246-900
Country
Brazil
Facility Name
Brasilmed Assistencia Medica E Pesquisas
City
São Paulo
ZIP/Postal Code
01416-000
Country
Brazil
Facility Name
Crt-Dst/Aids
City
São Paulo
ZIP/Postal Code
04121-000
Country
Brazil
Facility Name
Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
Canadian Immunodeficiency Research Collaborative (CIRC) Inc.
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B1L6
Country
Canada
Facility Name
University Health Network, Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
Clinique medicale l'Actuel
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4P9
Country
Canada
Facility Name
Clinique Medicale du Quartier Latin
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 5B1
Country
Canada
Facility Name
Immunodeficiency Service, McGill University Health Centre (MUHC) - Montreal Chest Institute
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 2P4
Country
Canada
Facility Name
Project LORI
City
Montreal
ZIP/Postal Code
H3H 1V1
Country
Canada
Facility Name
Rigshospitalet, Infektionsklinik 5112
City
Copenhagen
ZIP/Postal Code
2000
Country
Denmark
Facility Name
Instituto Dominicano de Estudios Virologicos - IDEV
City
Santo Domingo
Country
Dominican Republic
Facility Name
Service des Maladies Infectieuses, CHU de Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Hôpital de la Croix Rousse - Maladies Infectieuses et Tropicales
City
Lyon
ZIP/Postal Code
69288
Country
France
Facility Name
Hopital Sainte Marguerite Service d'Immuno-Hématologie Clinique -CISIH
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
CHU de Nantes Hopital de l'Hotel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Department of Infectious Diseases, Saint-Louis hospital
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hopital Saint Antoine, Service De Maladies Infectieuses
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Bichat Hospital
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Tenon Hospital, UPMC
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Maladies Infectieuses Dpt
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Centre François Magendie, Hôpital du Haut Lévêque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Centre Hospitalier de Tourcoing
City
Tourcoing
ZIP/Postal Code
59208
Country
France
Facility Name
EPIMED GmbH
City
Berlin
ZIP/Postal Code
12157
Country
Germany
Facility Name
Medizinische Universitätsklinik
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Infektio Research GmbH / Infektiologikum Frankfurt
City
Frankfurt am Main
ZIP/Postal Code
60311
Country
Germany
Facility Name
ICH Study Center Hamburg
City
Hamburg
ZIP/Postal Code
20146
Country
Germany
Facility Name
University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
University of Cologne, Department of Internal Medicine
City
Koln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Azienda Ospedaliera Luigi Sacco 1° Divisione Malattie Infettive
City
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
Fondazione Centro San Raffaele del Monte Tabor
City
Milan
ZIP/Postal Code
20127
Country
Italy
Facility Name
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
City
Roma
ZIP/Postal Code
00149
Country
Italy
Facility Name
Dipartimento di Malattie Infettive
City
Torino
ZIP/Postal Code
10149
Country
Italy
Facility Name
Unidad de VIH, Hospital Civil de Guadalajara, Fray Antonio Alcalde
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Onze lieve vrouw gasthuis
City
Amsterdam
ZIP/Postal Code
1091 AC
Country
Netherlands
Facility Name
Hospital de Santa Maria - CHLN
City
Lisbon
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Serviço de Doenças Infecciosas, Hospital de São João
City
Porto
ZIP/Postal Code
4202-451
Country
Portugal
Facility Name
Instituto de Investigacion Clentifica del Sur
City
Ponce
ZIP/Postal Code
00731
Country
Puerto Rico
Facility Name
Clinical Research Puerto Rico
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
CHUV
City
Lausanne
State/Province
VD
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Universitätsklinik für Infektiologie, Universitätsspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Division of Infectious Diseases and Hospital Hygiene; University Hospital of Zurich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
HIV-NAT, Thai Red Cross AIDS Research Center and Faculty of Medicine Chulalongkorn University
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Ramathibodi Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Maharaj Nakorn Chiang Mai University, Faculty of Medicine, Department of Medicine
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Khon Kaen University
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Brighton and Sussex University Hospitals NHS Trust
City
Brighton
State/Province
East Sussex
ZIP/Postal Code
BN2 1ES
Country
United Kingdom
Facility Name
Barts and the London NHS Trust
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Homerton University Hospital
City
London
ZIP/Postal Code
E9 6SR
Country
United Kingdom
Facility Name
Guys and St. Thomas' NHS Trust
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
Courtyard Clinic, St. Georges Hospital
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23532097
Citation
Gallant JE, Koenig E, Andrade-Villanueva J, Chetchotisakd P, DeJesus E, Antunes F, Arasteh K, Moyle G, Rizzardini G, Fehr J, Liu Y, Zhong L, Callebaut C, Szwarcberg J, Rhee MS, Cheng AK. Cobicistat versus ritonavir as a pharmacoenhancer of atazanavir plus emtricitabine/tenofovir disoproxil fumarate in treatment-naive HIV type 1-infected patients: week 48 results. J Infect Dis. 2013 Jul;208(1):32-9. doi: 10.1093/infdis/jit122. Epub 2013 Mar 26.
Results Reference
result
PubMed Identifier
26181707
Citation
Gallant JE, Koenig E, Andrade-Villanueva JF, Chetchotisakd P, DeJesus E, Antunes F, Arasteh K, Rizzardini G, Fehr J, Liu HC, Abram ME, Cao H, Szwarcberg J. Brief Report: Cobicistat Compared With Ritonavir as a Pharmacoenhancer for Atazanavir in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate: Week 144 Results. J Acquir Immune Defic Syndr. 2015 Jul 1;69(3):338-40. doi: 10.1097/QAI.0000000000000598.
Results Reference
result
PubMed Identifier
27774892
Citation
Gallant J, Moyle G, Berenguer J, Shalit P, Cao H, Liu YP, Myers J, Rosenblatt L, Yang L, Szwarcberg J. Atazanavir Plus Cobicistat: Week 48 and Week 144 Subgroup Analyses of a Phase 3, Randomized, Double-Blind, Active-Controlled Trial. Curr HIV Res. 2017;15(3):216-224. doi: 10.2174/1570162X14666161021102728.
Results Reference
derived

Learn more about this trial

Safety and Efficacy of COBI-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

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