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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

Sponsor
Gilead Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT01108510
Collaborator
(none)
698
Enrollment
134
Locations
2
Arms
60
Duration (Months)
5.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
698 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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 Start Date :
Apr 1, 2010
Actual Primary Completion Date :
Nov 1, 2011
Actual Study Completion Date :
Apr 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: ATV+COBI+FTC/TDF

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

Drug: COBI
Cobicistat (COBI) 150 mg tablet administered orally once daily
Other Names:
  • Tybost®
  • GS-9350

    • Drug: ATV
    Atazanavir (ATV) 300 mg capsule administered orally once daily
    Other Names:
  • Reyataz®

    • Drug: FTC/TDF
    Emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination tablet administered orally once daily
    Other Names:
  • Truvada®

    • Drug: RTV placebo
    Placebo to match RTV administered orally once daily
    Active Comparator: ATV+RTV+FTC/TDF

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

    Drug: RTV
    Ritonavir (RTV) 100 mg tablet administered orally once daily
    Other Names:
  • Norvir®

    • Drug: ATV
    Atazanavir (ATV) 300 mg capsule administered orally once daily
    Other Names:
  • Reyataz®

    • Drug: FTC/TDF
    Emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination tablet administered orally once daily
    Other Names:
  • Truvada®

    • Drug: COBI placebo
    Placebo to match COBI administered orally once daily

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 [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

    1. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 [Week 96]

      The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm.

    2. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144 [Week 144]

      The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 144 was analyzed using the snapshot algorithm.

    3. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 192 [Week 192]

      The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 192 was analyzed using the snapshot algorithm.

    4. Change From Baseline in CD4 Cell Count at Week 48 [Baseline to Week 48]

    5. Change From Baseline in CD4 Cell Count at Week 96 [Baseline to Week 96]

    6. Change From Baseline in CD4 Cell Count at Week 144 [Baseline to Week 144]

    7. Change From Baseline in CD4 Cell Count at Week 192 [Baseline to Week 192]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35294
    2 Spectrum Medical Group Phoenix Arizona United States 85012
    3 Health for Life Clinic PLLC Little Rock Arkansas United States 72207
    4 Living Hope Clinical Foundation Long Beach California United States 90813
    5 Kaiser Permanente Los Angeles California United States 90027
    6 Los Angeles Gay and Lesbian Center DBA Jeffrey Goodman Special Care Clinic Los Angeles California United States 90028
    7 Peter J Ruane, MD, Inc Los Angeles California United States 90036
    8 Oasis Clinic Los Angeles California United States 90059
    9 Anthony Mills MD Inc Los Angeles California United States 90069
    10 University of California, Davis Medical Center Sacramento California United States 95817
    11 Kaiser Permanente Medical Group Sacramento California United States 95825
    12 La Playa Medical Group and Clinical Research San Diego California United States 92103
    13 Metropolis Medical San Francisco California United States 94115
    14 Kaiser Permanente Medical Center, Clinical Trials Unit San Francisco California United States 94118
    15 Apex Research, LLC Denver Colorado United States 80220
    16 Dupont Circle Physicians Group Washington District of Columbia United States 20009
    17 Whitman-Walker Clinic Washington District of Columbia United States 20009
    18 George Washington University Medical Faculty Associates Washington District of Columbia United States 20037
    19 Therafirst Medical Center Fort Lauderdale Florida United States 33308
    20 Broward Health/Comprehensive Care Center Fort Lauderdale Florida United States 33311
    21 Midway Immunology and Research Center Fort Pierce Florida United States 34982
    22 Wohlfeiler, Piperato and Associates, LLC Miami Beach Florida United States 33139
    23 The Kinder Medical Group Miami Florida United States 33133
    24 University of Miami School of Medicine Miami Florida United States 33136
    25 Orlando Immunology Center Orlando Florida United States 32803
    26 Idocf/ Valuhealthmd, Llc Orlando Florida United States 32806
    27 University of South Florida HIV Clinical Research Unit / Hillsborough County Health Department Tampa Florida United States 33602
    28 Infectious Disease Research Institute Inc. Tampa Florida United States 33614
    29 St. Joseph's Comprehensive Research Institute Tampa Florida United States 33615
    30 Infectious Disease Specialists of Atlanta Decatur Georgia United States 30033
    31 Mercer University School of Medicine Macon Georgia United States 31210
    32 Howard Brown Health Center Chicago Illinois United States 60613
    33 Johns Hopkins University School of Medicine Baltimore Maryland United States 21205
    34 Community Research Initiative of New England Boston Massachusetts United States 02215
    35 Be Well Medical Center Berkley Michigan United States 48072
    36 Henry Ford Health System Detroit Michigan United States 48202
    37 Hennepin County Medical Center Minneapolis Minnesota United States 55415
    38 CentralWest Clinical Research St. Louis Missouri United States 63108
    39 Saint Michaels Medical Center Newark New Jersey United States 07102
    40 South Jersey Infectious Disease Somers Point New Jersey United States 08244
    41 SouthWest CARE Center Santa Fe New Mexico United States 87505
    42 Montefiore Medical Center - AIDS Center Bronx New York United States 10467
    43 North Shore University Hospital Manhasset New York United States 11030
    44 Chelsea Village Medical, PC New York New York United States 10011
    45 Mt Sinai School of Medicine New York New York United States 10011
    46 Ricky K. Hsu, MD, PC New York New York United States 10011
    47 Carolinas Medical Center-Myers Park Charlotte North Carolina United States 28207
    48 Duke University Medical Center Durham North Carolina United States 27710
    49 East Carolina University, The Brody School of Medicine Greenville North Carolina United States 27834
    50 Rosedale Infectious Diseases Huntersville North Carolina United States 28078
    51 Wake Forest University Health Sciences Winston Salem North Carolina United States 27157
    52 University of Pennsylvania Philadelphia Pennsylvania United States 19104
    53 Division of Infectious Diseases, Thomas Jefferson University Philadelphia Pennsylvania United States 19107
    54 Philadelphia FIGHT Philadelphia Pennsylvania United States 19107
    55 University of South Carolina Columbia South Carolina United States 29203
    56 Southwest Infectious Disease Clinical Research, Inc. Dallas Texas United States 75204
    57 Tarrant County Infectious Disease Associates Fort Worth Texas United States 76104
    58 Garcia's Family Health Group Harlingen Texas United States 78550
    59 Therapeutic Concepts, PA Houston Texas United States 77004
    60 Gordon E. Crofoot MD PA Houston Texas United States 77098
    61 Research Access Network Houston Texas United States 77098
    62 DCOL Center for Clinical Research Longview Texas United States 75605
    63 Peter Shalit, M.D. Seattle Washington United States 98104
    64 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    65 St Vincent's Hospital, Sydney Darlinghurst New South Wales Australia 2010
    66 Taylor Square Private Clinic Darlinghurst New South Wales Australia 2010
    67 Albion Street Centre Sydney New South Wales Australia 2010
    68 Holdsworth House Medical practice Sydney New South Wales Australia 2010
    69 Melbourne Sexual Health Centre Carlton Victoria Australia 3053
    70 Alfred Hospital Melbourne Victoria Australia 3004
    71 Northside Clinic Melbourne Victoria Australia 3068
    72 LKH Graz West Graz Austria A-8010
    73 Allgemeines Krankenhaus Vienna Austria 1090
    74 Interne Lungenabteilung, SMZ Baumgartner Hoehe - Otto-Wagner-Spital Vienna Austria 1140
    75 CHU Saint-Pierre University Hospital Brussels Belgium 1000
    76 Hôpital Universitaire Erasme - ULB Brussels Belgium 1070
    77 University of Ghent Ghent Belgium 9000
    78 Instituto De Pesquisa Clinica Evandro Chagas Rio de Janeiro RJ Brazil 21040-900
    79 URDIP Faculdade de Medicina do ABC Santo Andre Sao Paulo Brazil 09060-650
    80 Universidade Estadual de Campinas Campinas Brazil 13083-970
    81 Instituto De Infectologia Emilo Ribas São Paulo Brazil 01246-900
    82 Brasilmed Assistencia Medica E Pesquisas São Paulo Brazil 01416-000
    83 Crt-Dst/Aids São Paulo Brazil 04121-000
    84 Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg Winnipeg Manitoba Canada R3A 1R9
    85 Canadian Immunodeficiency Research Collaborative (CIRC) Inc. Toronto Ontario Canada M5B1L6
    86 University Health Network, Toronto General Hospital Toronto Ontario Canada M5G 2N2
    87 Clinique medicale l'Actuel Montreal Quebec Canada H2L 4P9
    88 Clinique Medicale du Quartier Latin Montreal Quebec Canada H2L 5B1
    89 Immunodeficiency Service, McGill University Health Centre (MUHC) - Montreal Chest Institute Montréal Quebec Canada H2X 2P4
    90 Project LORI Montreal Canada H3H 1V1
    91 Rigshospitalet, Infektionsklinik 5112 Copenhagen Denmark 2000
    92 Instituto Dominicano de Estudios Virologicos - IDEV Santo Domingo Dominican Republic
    93 Service des Maladies Infectieuses, CHU de Caen Caen France 14033
    94 Hôpital de la Croix Rousse - Maladies Infectieuses et Tropicales Lyon France 69288
    95 Hopital Sainte Marguerite Service d'Immuno-Hématologie Clinique -CISIH Marseille France 13009
    96 CHU de Nantes Hopital de l'Hotel Dieu Nantes France 44093
    97 Department of Infectious Diseases, Saint-Louis hospital Paris France 75010
    98 Hopital Saint Antoine, Service De Maladies Infectieuses Paris France 75012
    99 Bichat Hospital Paris France 75018
    100 Tenon Hospital, UPMC Paris France 75020
    101 Maladies Infectieuses Dpt Paris France 75651
    102 Centre François Magendie, Hôpital du Haut Lévêque Pessac France 33604
    103 Centre Hospitalier de Tourcoing Tourcoing France 59208
    104 EPIMED GmbH Berlin Germany 12157
    105 Medizinische Universitätsklinik Bonn Germany 53127
    106 Infektio Research GmbH / Infektiologikum Frankfurt Frankfurt am Main Germany 60311
    107 ICH Study Center Hamburg Hamburg Germany 20146
    108 University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit Hamburg Germany 20246
    109 University of Cologne, Department of Internal Medicine Koln Germany 50937
    110 Azienda Ospedaliera Luigi Sacco 1° Divisione Malattie Infettive Milano Italy 20157
    111 Fondazione Centro San Raffaele del Monte Tabor Milan Italy 20127
    112 Istituto Nazionale Malattie Infettive Lazzaro Spallanzani Roma Italy 00149
    113 Dipartimento di Malattie Infettive Torino Italy 10149
    114 Unidad de VIH, Hospital Civil de Guadalajara, Fray Antonio Alcalde Guadalajara Jalisco Mexico 44280
    115 Onze lieve vrouw gasthuis Amsterdam Netherlands 1091 AC
    116 Hospital de Santa Maria - CHLN Lisbon Portugal 1649-035
    117 Serviço de Doenças Infecciosas, Hospital de São João Porto Portugal 4202-451
    118 Instituto de Investigacion Clentifica del Sur Ponce Puerto Rico 00731
    119 Clinical Research Puerto Rico San Juan Puerto Rico 00909
    120 Hospital General Universitario Gregorio Marañon Madrid Spain 28007
    121 Hospital Virgen del Rocio Sevilla Spain 41013
    122 CHUV Lausanne VD Switzerland 1011
    123 Universitätsklinik für Infektiologie, Universitätsspital Bern Bern Switzerland 3010
    124 Division of Infectious Diseases and Hospital Hygiene; University Hospital of Zurich Zürich Switzerland 8091
    125 HIV-NAT, Thai Red Cross AIDS Research Center and Faculty of Medicine Chulalongkorn University Bangkok Thailand 10330
    126 Ramathibodi Hospital, Mahidol University Bangkok Thailand 10400
    127 Siriraj Hospital Bangkok Thailand 10700
    128 Maharaj Nakorn Chiang Mai University, Faculty of Medicine, Department of Medicine Chiang Mai Thailand 50200
    129 Khon Kaen University Khon Kaen Thailand 40002
    130 Brighton and Sussex University Hospitals NHS Trust Brighton East Sussex United Kingdom BN2 1ES
    131 Barts and the London NHS Trust London United Kingdom E1 1BB
    132 Homerton University Hospital London United Kingdom E9 6SR
    133 Guys and St. Thomas' NHS Trust London United Kingdom SE1 7EH
    134 Courtyard Clinic, St. Georges Hospital London United Kingdom SW17 0QT

    Sponsors and Collaborators

    • Gilead Sciences

    Investigators

    • Study Director: Huyen Cao, MD, Gilead Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT01108510
    Other Study ID Numbers:
    • GS-US-216-0114
    • 2009-016759-22
    First Posted:
    Apr 22, 2010
    Last Update Posted:
    May 23, 2016
    Last Verified:
    Apr 1, 2016
    Keywords provided by Gilead Sciences
    Treatment Naive
    HIV 1 Infected
    Additional relevant MeSH terms:
    HIV Infections
    Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
    Atazanavir Sulfate
    Cobicistat

    Study Results

    Participant Flow

    Recruitment Details Participants were enrolled in a total of 144 study sites in Asia, Australia, Europe, and South and North America. The last study visit occurred on 17 April 2015.
    Pre-assignment Detail 867 participants were screened.
    Arm/Group Title ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF
    Arm/Group Description Cobicistat (COBI) 150 mg + ritonavir (RTV) placebo + atazanavir (ATV) 300 mg + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg) once daily RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
    Period Title: Overall Study
    STARTED 349 349
    COMPLETED 70 81
    NOT COMPLETED 279 268

    Baseline Characteristics

    Arm/Group Title ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF Total
    Arm/Group Description COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily Total of all reporting groups
    Overall Participants 344 348 692
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    37
    (9.8)
    38
    (9.6)
    37
    (9.7)
    Sex: Female, Male (Count of Participants)
    Female
    57
    16.6%
    61
    17.5%
    118
    17.1%
    Male
    287
    83.4%
    287
    82.5%
    574
    82.9%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    97
    28.2%
    92
    26.4%
    189
    27.3%
    Not Hispanic or Latino
    245
    71.2%
    253
    72.7%
    498
    72%
    Unknown or Not Reported
    2
    0.6%
    3
    0.9%
    5
    0.7%
    Race/Ethnicity, Customized (participants) [Number]
    American Indian or Alaska Native
    1
    0.3%
    2
    0.6%
    3
    0.4%
    Asian
    44
    12.8%
    37
    10.6%
    81
    11.7%
    Black or African Heritage
    65
    18.9%
    63
    18.1%
    128
    18.5%
    Native Hawaiian or Pacific Islander
    1
    0.3%
    1
    0.3%
    2
    0.3%
    White
    198
    57.6%
    215
    61.8%
    413
    59.7%
    Not Permitted
    2
    0.6%
    3
    0.9%
    5
    0.7%
    Other
    33
    9.6%
    27
    7.8%
    60
    8.7%
    Region of Enrollment (participants) [Number]
    Australia
    7
    2%
    8
    2.3%
    15
    2.2%
    Austria
    13
    3.8%
    5
    1.4%
    18
    2.6%
    Belgium
    7
    2%
    11
    3.2%
    18
    2.6%
    Brazil
    18
    5.2%
    17
    4.9%
    35
    5.1%
    Canada
    26
    7.6%
    18
    5.2%
    44
    6.4%
    Denmark
    0
    0%
    2
    0.6%
    2
    0.3%
    Dominican Republic
    27
    7.8%
    31
    8.9%
    58
    8.4%
    France
    12
    3.5%
    19
    5.5%
    31
    4.5%
    Germany
    17
    4.9%
    21
    6%
    38
    5.5%
    Italy
    6
    1.7%
    15
    4.3%
    21
    3%
    Mexico
    18
    5.2%
    17
    4.9%
    35
    5.1%
    Netherlands
    0
    0%
    1
    0.3%
    1
    0.1%
    Portugal
    9
    2.6%
    5
    1.4%
    14
    2%
    Spain
    3
    0.9%
    4
    1.1%
    7
    1%
    Switzerland
    3
    0.9%
    12
    3.4%
    15
    2.2%
    Thailand
    35
    10.2%
    31
    8.9%
    66
    9.5%
    United Kingdom
    14
    4.1%
    18
    5.2%
    32
    4.6%
    United States
    134
    39%
    114
    32.8%
    248
    35.8%
    HIV-1 RNA (log10 copies/mL) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [log10 copies/mL]
    4.81
    (0.585)
    4.84
    (0.594)
    4.83
    (0.589)
    HIV-1 RNA Category (participants) [Number]
    ≤ 100,000 copies/mL
    212
    61.6%
    205
    58.9%
    417
    60.3%
    > 100,000 copies/mL
    132
    38.4%
    143
    41.1%
    275
    39.7%
    Cluster of differentiation (CD4) Cell Count (cells/µL) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [cells/µL]
    353
    (170.5)
    351
    (175.5)
    352
    (172.9)
    CD4 Cell Count Category (participants) [Number]
    ≤ 50 cells/μL
    11
    (3.2) 3.2%
    12
    3.4%
    23
    3.3%
    51 to ≤ 200 cells/μL
    49
    14.2%
    45
    12.9%
    94
    13.6%
    201 to ≤ 350 cells/μL
    114
    33.1%
    126
    36.2%
    240
    34.7%
    351 to ≤ 500 cells/μL
    123
    35.8%
    117
    33.6%
    240
    34.7%
    > 500 cells/μL
    47
    13.7%
    48
    13.8%
    95
    13.7%
    HIV Disease Status (participants) [Number]
    Asymptomatic
    285
    82.8%
    292
    83.9%
    577
    83.4%
    Symptomatic HIV Infections
    31
    9%
    32
    9.2%
    63
    9.1%
    AIDS
    28
    8.1%
    24
    6.9%
    52
    7.5%
    Hepatitis B Surface Antigen Status (participants) [Number]
    Positive
    16
    4.7%
    9
    2.6%
    25
    3.6%
    Negative
    328
    95.3%
    339
    97.4%
    667
    96.4%
    Hepatitis C Antibody Status (participants) [Number]
    Positive
    21
    6.1%
    16
    4.6%
    37
    5.3%
    Negative
    323
    93.9%
    331
    95.1%
    654
    94.5%
    Indeterminate
    0
    0%
    1
    0.3%
    1
    0.1%

    Outcome Measures

    1. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    Intent-to-Treat (ITT) Analysis Set: participants who were randomized and received at least one dose of study drug
    Arm/Group Title ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF
    Arm/Group Description COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
    Measure Participants 344 348
    Number [percentage of participants]
    85.2
    24.8%
    87.4
    25.1%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ATV+COBI+FTC/TDF, ATV+RTV+FTC/TDF
    Comments 700 planned subjects had 95% power to evaluate noninferiority assuming a response rate of 79.5% for both arms and a noninferiority margin of 12%.
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments Null hypothesis: ATV+COBI+FTC/TDF group was at least 12% worse than the ATV+RTV+FTC/TDF group; alternative hypothesis: ATV+COBI+FTC/TDF group was less than 12% worse than the ATV+RTV+FTC/TDF group. ATV+COBI+FTC/TDF was noninferior if the lower bound of the 2-sided 95.2% confidence interval (CI) (COBI group - RTV group) was > -12%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentages
    Estimated Value -2.2
    Confidence Interval (2-Sided) 95.2%
    -7.4 to 3.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments Difference in percentages of success and its 95.2% confidence interval (CI) were calculated based on baseline HIV-1 RNA stratum-adjusted Mantel-Haenszel (MH) proportion.
    2. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    ITT Analysis Set
    Arm/Group Title ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF
    Arm/Group Description COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
    Measure Participants 344 348
    Number [percentage of participants]
    77.9
    22.6%
    79.3
    22.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ATV+COBI+FTC/TDF, ATV+RTV+FTC/TDF
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments The null hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was at least 12% worse than the response rate in ATV+RTV+FTC/TDF group; the alternative hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was less than 12% worse than that in the ATV+RTV+FTC/TDF group.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentages
    Estimated Value -1.4
    Confidence Interval (2-Sided) 95%
    -7.6 to 4.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments Difference in percentages of success and its 95% CI were calculated based on baseline HIV-1 RNA stratum-adjusted MH proportion.
    3. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    ITT Analysis Set
    Arm/Group Title ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF
    Arm/Group Description COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
    Measure Participants 344 348
    Number [percentage of participants]
    72.1
    21%
    74.1
    21.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ATV+COBI+FTC/TDF, ATV+RTV+FTC/TDF
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments The null hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was at least 12% worse than the response rate in ATV+RTV+FTC/TDF group; the alternative hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was less than 12% worse than that in the ATV+RTV+FTC/TDF group.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentages
    Estimated Value -2.1
    Confidence Interval (2-Sided) 95%
    -8.7 to 4.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments Difference in percentages of success and its 95% CI were calculated based on baseline HIV-1 RNA stratum-adjusted MH proportion.
    4. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    Week 192 Modified ITT Analysis Set: includes participants in the ITT analysis set excluding those who either (1) transferred to other Gilead-sponsored studies after completing their Week 144 visit and before the lower limit of the Week 192 analysis window, or (2) prematurely discontinued study drug prior to the Week 144 visit.
    Arm/Group Title ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF
    Arm/Group Description COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
    Measure Participants 74 69
    Number [percentage of participants]
    71.6
    20.8%
    79.7
    22.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ATV+COBI+FTC/TDF, ATV+RTV+FTC/TDF
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments The null hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was at least 12% worse than the response rate in ATV+RTV+FTC/TDF group; the alternative hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was less than 12% worse than that in the ATV+RTV+FTC/TDF group.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentages
    Estimated Value -8.0
    Confidence Interval (2-Sided) 95%
    -22.2 to 6.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments Difference in percentages of success and its 95% CI were calculated based on baseline HIV-1 RNA stratum-adjusted MH proportion.
    5. Secondary Outcome
    Title Change From Baseline in CD4 Cell Count at Week 48
    Description
    Time Frame Baseline to Week 48

    Outcome Measure Data

    Analysis Population Description
    Participants in the ITT Analysis Set with available change data at Week 48 were analyzed.
    Arm/Group Title ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF
    Arm/Group Description COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
    Measure Participants 313 324
    Mean (Standard Deviation) [cells/μL]
    213
    (151.0)
    219
    (150.4)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ATV+COBI+FTC/TDF, ATV+RTV+FTC/TDF
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.67
    Comments P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter Difference in least squares mean (LSM)
    Estimated Value -5
    Confidence Interval (2-Sided) 95%
    -28 to 18
    Parameter Dispersion Type:
    Value:
    Estimation Comments The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.
    6. Secondary Outcome
    Title Change From Baseline in CD4 Cell Count at Week 96
    Description
    Time Frame Baseline to Week 96

    Outcome Measure Data

    Analysis Population Description
    Participants in the ITT Analysis Set with available change data at Week 96 were analyzed.
    Arm/Group Title ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF
    Arm/Group Description COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
    Measure Participants 300 311
    Mean (Standard Deviation) [cells/μL]
    277
    (176.8)
    287
    (181.5)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ATV+COBI+FTC/TDF, ATV+RTV+FTC/TDF
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.51
    Comments P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LSM
    Estimated Value -10
    Confidence Interval (2-Sided) 95%
    -38 to 19
    Parameter Dispersion Type:
    Value:
    Estimation Comments The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.
    7. Secondary Outcome
    Title Change From Baseline in CD4 Cell Count at Week 144
    Description
    Time Frame Baseline to Week 144

    Outcome Measure Data

    Analysis Population Description
    Participants in the ITT Analysis Set with available change data at Week 144 were analyzed.
    Arm/Group Title ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF
    Arm/Group Description COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
    Measure Participants 275 288
    Mean (Standard Deviation) [cells/μL]
    310
    (188.0)
    332
    (199.8)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ATV+COBI+FTC/TDF, ATV+RTV+FTC/TDF
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.18
    Comments P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LSM
    Estimated Value -22
    Confidence Interval (2-Sided) 95%
    -54 to 10
    Parameter Dispersion Type:
    Value:
    Estimation Comments The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.
    8. Secondary Outcome
    Title Change From Baseline in CD4 Cell Count at Week 192
    Description
    Time Frame Baseline to Week 192

    Outcome Measure Data

    Analysis Population Description
    Participants in the ITT Analysis Set with available change data at Week 192 were analyzed.
    Arm/Group Title ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF
    Arm/Group Description COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
    Measure Participants 73 83
    Mean (Standard Deviation) [cells/μL]
    350
    (191.3)
    343
    (190.7)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ATV+COBI+FTC/TDF, ATV+RTV+FTC/TDF
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.84
    Comments P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LSM
    Estimated Value 6
    Confidence Interval (2-Sided) 95%
    -55 to 67
    Parameter Dispersion Type:
    Value:
    Estimation Comments The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.

    Adverse Events

    Time Frame Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
    Adverse Event Reporting Description Safety Analysis Set: participants who were randomized and received at least one dose of study drug
    Arm/Group Title ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF
    Arm/Group Description COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
    All Cause Mortality
    ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 64/344 (18.6%) 50/348 (14.4%)
    Blood and lymphatic system disorders
    Anaemia 1/344 (0.3%) 1/348 (0.3%)
    Coagulopathy 1/344 (0.3%) 0/348 (0%)
    Leukocytosis 1/344 (0.3%) 0/348 (0%)
    Thrombocytopenia 1/344 (0.3%) 0/348 (0%)
    Cardiac disorders
    Arrhythmia 0/344 (0%) 1/348 (0.3%)
    Atrial tachycardia 1/344 (0.3%) 0/348 (0%)
    Bradycardia 0/344 (0%) 1/348 (0.3%)
    Palpitations 1/344 (0.3%) 1/348 (0.3%)
    Ear and labyrinth disorders
    Deafness unilateral 0/344 (0%) 1/348 (0.3%)
    Tinnitus 0/344 (0%) 1/348 (0.3%)
    Vertigo 0/344 (0%) 1/348 (0.3%)
    Gastrointestinal disorders
    Abdominal mass 1/344 (0.3%) 0/348 (0%)
    Abdominal pain 1/344 (0.3%) 0/348 (0%)
    Abdominal pain upper 1/344 (0.3%) 0/348 (0%)
    Colitis 2/344 (0.6%) 0/348 (0%)
    Crohn's disease 1/344 (0.3%) 0/348 (0%)
    Diarrhoea 1/344 (0.3%) 0/348 (0%)
    Enteritis 1/344 (0.3%) 0/348 (0%)
    Food poisoning 1/344 (0.3%) 0/348 (0%)
    Gastric ulcer 1/344 (0.3%) 0/348 (0%)
    Gastritis erosive 1/344 (0.3%) 0/348 (0%)
    Gastroduodenal ulcer 0/344 (0%) 1/348 (0.3%)
    Haematemesis 1/344 (0.3%) 0/348 (0%)
    Haematochezia 1/344 (0.3%) 0/348 (0%)
    Haemorrhoidal haemorrhage 1/344 (0.3%) 0/348 (0%)
    General disorders
    Chest pain 3/344 (0.9%) 3/348 (0.9%)
    General physical health deterioration 1/344 (0.3%) 0/348 (0%)
    Oedema peripheral 1/344 (0.3%) 0/348 (0%)
    Pyrexia 3/344 (0.9%) 3/348 (0.9%)
    Immune system disorders
    Immune reconstitution inflammatory syndrome 0/344 (0%) 1/348 (0.3%)
    Infections and infestations
    Abdominal wall abscess 1/344 (0.3%) 0/348 (0%)
    Abscess limb 1/344 (0.3%) 2/348 (0.6%)
    Abscess neck 1/344 (0.3%) 0/348 (0%)
    Anal abscess 1/344 (0.3%) 0/348 (0%)
    Appendicitis 0/344 (0%) 1/348 (0.3%)
    Appendicitis perforated 1/344 (0.3%) 0/348 (0%)
    Bacteraemia 1/344 (0.3%) 0/348 (0%)
    Bronchopneumonia 0/344 (0%) 1/348 (0.3%)
    Cellulitis 2/344 (0.6%) 2/348 (0.6%)
    Chancroid 1/344 (0.3%) 0/348 (0%)
    Dengue fever 1/344 (0.3%) 0/348 (0%)
    Diverticulitis 0/344 (0%) 1/348 (0.3%)
    Enterobacter sepsis 1/344 (0.3%) 0/348 (0%)
    Gastroenteritis 1/344 (0.3%) 3/348 (0.9%)
    Gastroenteritis salmonella 0/344 (0%) 1/348 (0.3%)
    Gastroenteritis shigella 0/344 (0%) 1/348 (0.3%)
    Genital abscess 0/344 (0%) 1/348 (0.3%)
    Gonorrhoea 1/344 (0.3%) 0/348 (0%)
    Groin abscess 1/344 (0.3%) 0/348 (0%)
    Herpes zoster 3/344 (0.9%) 0/348 (0%)
    Infected dermal cyst 0/344 (0%) 1/348 (0.3%)
    Infectious colitis 0/344 (0%) 1/348 (0.3%)
    Influenza 2/344 (0.6%) 0/348 (0%)
    Meningitis toxoplasmal 0/344 (0%) 1/348 (0.3%)
    Meningitis viral 1/344 (0.3%) 0/348 (0%)
    Oesophageal candidiasis 1/344 (0.3%) 0/348 (0%)
    Orchitis 1/344 (0.3%) 0/348 (0%)
    Osteomyelitis 0/344 (0%) 1/348 (0.3%)
    Osteomyelitis acute 0/344 (0%) 1/348 (0.3%)
    Otitis media chronic 1/344 (0.3%) 0/348 (0%)
    Perineal abscess 1/344 (0.3%) 0/348 (0%)
    Peritonitis 0/344 (0%) 1/348 (0.3%)
    Pharyngitis streptococcal 0/344 (0%) 1/348 (0.3%)
    Pneumocystis jirovecii pneumonia 1/344 (0.3%) 1/348 (0.3%)
    Pneumonia 2/344 (0.6%) 2/348 (0.6%)
    Pneumonia bacterial 0/344 (0%) 1/348 (0.3%)
    Pneumonia mycoplasmal 1/344 (0.3%) 0/348 (0%)
    Post procedural infection 1/344 (0.3%) 0/348 (0%)
    Pulmonary tuberculosis 1/344 (0.3%) 0/348 (0%)
    Pyelonephritis 1/344 (0.3%) 0/348 (0%)
    Scrotal abscess 1/344 (0.3%) 0/348 (0%)
    Sepsis 2/344 (0.6%) 2/348 (0.6%)
    Skin infection 1/344 (0.3%) 0/348 (0%)
    Subcutaneous abscess 4/344 (1.2%) 0/348 (0%)
    Tuberculosis 0/344 (0%) 1/348 (0.3%)
    Urinary tract infection 0/344 (0%) 1/348 (0.3%)
    Injury, poisoning and procedural complications
    Ankle fracture 1/344 (0.3%) 0/348 (0%)
    Carbon monoxide poisoning 0/344 (0%) 1/348 (0.3%)
    Clavicle fracture 1/344 (0.3%) 0/348 (0%)
    Femur fracture 0/344 (0%) 1/348 (0.3%)
    Hand fracture 0/344 (0%) 1/348 (0.3%)
    Ligament rupture 1/344 (0.3%) 0/348 (0%)
    Lumbar vertebral fracture 0/344 (0%) 1/348 (0.3%)
    Overdose 0/344 (0%) 1/348 (0.3%)
    Renal haematoma 1/344 (0.3%) 0/348 (0%)
    Tendon rupture 0/344 (0%) 1/348 (0.3%)
    Thoracic vertebral fracture 0/344 (0%) 1/348 (0.3%)
    Upper limb fracture 1/344 (0.3%) 0/348 (0%)
    Wrist fracture 0/344 (0%) 1/348 (0.3%)
    Investigations
    Blood creatine phosphokinase increased 1/344 (0.3%) 0/348 (0%)
    Coma scale abnormal 1/344 (0.3%) 0/348 (0%)
    Gamma-glutamyltransferase increased 0/344 (0%) 1/348 (0.3%)
    Hepatic enzyme increased 1/344 (0.3%) 0/348 (0%)
    White blood cell count increased 1/344 (0.3%) 0/348 (0%)
    Metabolism and nutrition disorders
    Dehydration 1/344 (0.3%) 1/348 (0.3%)
    Diabetes mellitus 2/344 (0.6%) 0/348 (0%)
    Diabetic ketoacidosis 0/344 (0%) 1/348 (0.3%)
    Hyperglycaemia 1/344 (0.3%) 0/348 (0%)
    Hypertriglyceridaemia 1/344 (0.3%) 0/348 (0%)
    Hypoglycaemia 0/344 (0%) 1/348 (0.3%)
    Malnutrition 1/344 (0.3%) 0/348 (0%)
    Metabolic acidosis 0/344 (0%) 1/348 (0.3%)
    Type 2 diabetes mellitus 0/344 (0%) 1/348 (0.3%)
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion 1/344 (0.3%) 0/348 (0%)
    Muscular weakness 1/344 (0.3%) 0/348 (0%)
    Rhabdomyolysis 1/344 (0.3%) 0/348 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anogenital warts 1/344 (0.3%) 0/348 (0%)
    Burkitt's lymphoma 1/344 (0.3%) 0/348 (0%)
    Hodgkin's disease 0/344 (0%) 1/348 (0.3%)
    Uterine leiomyoma 1/344 (0.3%) 1/348 (0.3%)
    Nervous system disorders
    Ataxia 1/344 (0.3%) 0/348 (0%)
    Guillain-Barre syndrome 0/344 (0%) 1/348 (0.3%)
    Headache 1/344 (0.3%) 0/348 (0%)
    Migraine 1/344 (0.3%) 0/348 (0%)
    Subarachnoid haemorrhage 1/344 (0.3%) 0/348 (0%)
    Syncope 1/344 (0.3%) 0/348 (0%)
    Transient global amnesia 0/344 (0%) 1/348 (0.3%)
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous 2/344 (0.6%) 1/348 (0.3%)
    Psychiatric disorders
    Alcohol withdrawal syndrome 1/344 (0.3%) 0/348 (0%)
    Alcoholism 0/344 (0%) 1/348 (0.3%)
    Anxiety disorder 0/344 (0%) 2/348 (0.6%)
    Confusional state 0/344 (0%) 1/348 (0.3%)
    Depression 3/344 (0.9%) 1/348 (0.3%)
    Drug dependence 2/344 (0.6%) 0/348 (0%)
    Post-traumatic stress disorder 1/344 (0.3%) 0/348 (0%)
    Schizophrenia 1/344 (0.3%) 0/348 (0%)
    Substance-induced psychotic disorder 1/344 (0.3%) 0/348 (0%)
    Suicidal ideation 1/344 (0.3%) 0/348 (0%)
    Suicide attempt 0/344 (0%) 1/348 (0.3%)
    Renal and urinary disorders
    Calculus ureteric 2/344 (0.6%) 2/348 (0.6%)
    Fanconi syndrome acquired 1/344 (0.3%) 1/348 (0.3%)
    Nephritis 0/344 (0%) 1/348 (0.3%)
    Nephrolithiasis 1/344 (0.3%) 0/348 (0%)
    Nephropathy 1/344 (0.3%) 0/348 (0%)
    Renal colic 1/344 (0.3%) 0/348 (0%)
    Renal failure 0/344 (0%) 1/348 (0.3%)
    Renal failure acute 1/344 (0.3%) 4/348 (1.1%)
    Renal tubular acidosis 0/344 (0%) 1/348 (0.3%)
    Renal tubular necrosis 0/344 (0%) 1/348 (0.3%)
    Reproductive system and breast disorders
    Cervical dysplasia 2/344 (0.6%) 1/348 (0.3%)
    Colpocele 0/344 (0%) 1/348 (0.3%)
    Ovarian cyst 1/344 (0.3%) 0/348 (0%)
    Priapism 0/344 (0%) 2/348 (0.6%)
    Respiratory, thoracic and mediastinal disorders
    Asthma 1/344 (0.3%) 0/348 (0%)
    Chronic obstructive pulmonary disease 2/344 (0.6%) 0/348 (0%)
    Pneumonia aspiration 1/344 (0.3%) 0/348 (0%)
    Skin and subcutaneous tissue disorders
    Angioedema 1/344 (0.3%) 0/348 (0%)
    Rash 0/344 (0%) 1/348 (0.3%)
    Rash papular 1/344 (0.3%) 0/348 (0%)
    Skin abrasion 1/344 (0.3%) 0/348 (0%)
    Vasculitic rash 1/344 (0.3%) 0/348 (0%)
    Vascular disorders
    Hypovolaemic shock 0/344 (0%) 1/348 (0.3%)
    Other (Not Including Serious) Adverse Events
    ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 311/344 (90.4%) 312/348 (89.7%)
    Blood and lymphatic system disorders
    Lymphadenopathy 18/344 (5.2%) 26/348 (7.5%)
    Eye disorders
    Ocular icterus 69/344 (20.1%) 79/348 (22.7%)
    Gastrointestinal disorders
    Abdominal distension 16/344 (4.7%) 19/348 (5.5%)
    Abdominal pain 22/344 (6.4%) 26/348 (7.5%)
    Abdominal pain upper 19/344 (5.5%) 23/348 (6.6%)
    Diarrhoea 76/344 (22.1%) 96/348 (27.6%)
    Dyspepsia 15/344 (4.4%) 21/348 (6%)
    Flatulence 28/344 (8.1%) 10/348 (2.9%)
    Haemorrhoids 23/344 (6.7%) 21/348 (6%)
    Nausea 66/344 (19.2%) 66/348 (19%)
    Vomiting 34/344 (9.9%) 25/348 (7.2%)
    General disorders
    Fatigue 38/344 (11%) 34/348 (9.8%)
    Pyrexia 36/344 (10.5%) 30/348 (8.6%)
    Hepatobiliary disorders
    Hyperbilirubinaemia 42/344 (12.2%) 39/348 (11.2%)
    Jaundice 76/344 (22.1%) 61/348 (17.5%)
    Infections and infestations
    Bronchitis 33/344 (9.6%) 33/348 (9.5%)
    Folliculitis 18/344 (5.2%) 7/348 (2%)
    Gastroenteritis 12/344 (3.5%) 20/348 (5.7%)
    Influenza 25/344 (7.3%) 19/348 (5.5%)
    Nasopharyngitis 59/344 (17.2%) 79/348 (22.7%)
    Oral candidiasis 21/344 (6.1%) 19/348 (5.5%)
    Pharyngitis 17/344 (4.9%) 27/348 (7.8%)
    Sinusitis 28/344 (8.1%) 28/348 (8%)
    Syphilis 23/344 (6.7%) 26/348 (7.5%)
    Tinea pedis 18/344 (5.2%) 11/348 (3.2%)
    Upper respiratory tract infection 67/344 (19.5%) 65/348 (18.7%)
    Urinary tract infection 25/344 (7.3%) 25/348 (7.2%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 19/344 (5.5%) 19/348 (5.5%)
    Back pain 34/344 (9.9%) 42/348 (12.1%)
    Myalgia 18/344 (5.2%) 20/348 (5.7%)
    Pain in extremity 18/344 (5.2%) 15/348 (4.3%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anogenital warts 24/344 (7%) 16/348 (4.6%)
    Nervous system disorders
    Dizziness 32/344 (9.3%) 28/348 (8%)
    Headache 57/344 (16.6%) 73/348 (21%)
    Psychiatric disorders
    Anxiety 19/344 (5.5%) 16/348 (4.6%)
    Depression 25/344 (7.3%) 28/348 (8%)
    Insomnia 26/344 (7.6%) 29/348 (8.3%)
    Respiratory, thoracic and mediastinal disorders
    Cough 36/344 (10.5%) 29/348 (8.3%)
    Nasal congestion 15/344 (4.4%) 29/348 (8.3%)
    Oropharyngeal pain 20/344 (5.8%) 24/348 (6.9%)
    Skin and subcutaneous tissue disorders
    Rash 26/344 (7.6%) 31/348 (8.9%)
    Vascular disorders
    Hypertension 18/344 (5.2%) 23/348 (6.6%)

    Limitations/Caveats

    There were no limitations affecting the analysis or results.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or The study has been completed at all study sites for at least 2 years

    Results Point of Contact

    Name/Title Clinical Trial Disclosures
    Organization Gilead Sciences, Inc.
    Phone
    Email ClinicalTrialDisclosures@gilead.com
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT01108510
    Other Study ID Numbers:
    • GS-US-216-0114
    • 2009-016759-22
    First Posted:
    Apr 22, 2010
    Last Update Posted:
    May 23, 2016
    Last Verified:
    Apr 1, 2016