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HIVPhase 3NCT01108510

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

A Phase 3 study testing COBI, RTV and ATV in people with HIV and HIV Infections, run by Gilead Sciences at 134 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV, HIV Infections
What is being tested?
COBI, RTV and ATV
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
698 participants
Where
134 sitesin 19 countries
Study dates
Apr 2010to Apr 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 13Show fewer
  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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.

Trial locations and contacts

134 sites in 19 countries.

134 sites in 19 countries

United States64 sites

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21205

  • Be Well Medical Center

    Berkley, Michigan, 48072

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Community Research Initiative of New England

    Boston, Massachusetts, 02215

  • Carolinas Medical Center-Myers Park

    Charlotte, North Carolina, 28207

  • Howard Brown Health Center

    Chicago, Illinois, 60613

  • University of South Carolina

    Columbia, South Carolina, 29203

  • Southwest Infectious Disease Clinical Research, Inc.

    Dallas, Texas, 75204

  • Infectious Disease Specialists of Atlanta

    Decatur, Georgia, 30033

  • Apex Research, LLC

    Denver, Colorado, 80220

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Therafirst Medical Center

    Fort Lauderdale, Florida, 33308

  • Broward Health/Comprehensive Care Center

    Fort Lauderdale, Florida, 33311

  • Tarrant County Infectious Disease Associates

    Fort Worth, Texas, 76104

  • Midway Immunology and Research Center

    Ft. Pierce, Florida, 34982

  • East Carolina University, The Brody School of Medicine

    Greenville, North Carolina, 27834

  • Garcia's Family Health Group

    Harlingen, Texas, 78550

  • Therapeutic Concepts, PA

    Houston, Texas, 77004

  • Gordon E. Crofoot MD PA

    Houston, Texas, 77098

  • Research Access Network

    Houston, Texas, 77098

  • Rosedale Infectious Diseases

    Huntersville, North Carolina, 28078

  • Health for Life Clinic PLLC

    Little Rock, Arkansas, 72207

  • Living Hope Clinical Foundation

    Long Beach, California, 90813

  • DCOL Center for Clinical Research

    Longview, Texas, 75605

  • Kaiser Permanente

    Los Angeles, California, 90027

  • Los Angeles Gay and Lesbian Center DBA Jeffrey Goodman Special Care Clinic

    Los Angeles, California, 90028

  • Peter J Ruane, MD, Inc

    Los Angeles, California, 90036

  • Oasis Clinic

    Los Angeles, California, 90059

  • Anthony Mills MD Inc

    Los Angeles, California, 90069

  • Mercer University School of Medicine

    Macon, Georgia, 31210

  • North Shore University Hospital

    Manhasset, New York, 11030

  • The Kinder Medical Group

    Miami, Florida, 33133

  • University of Miami School of Medicine

    Miami, Florida, 33136

  • Wohlfeiler, Piperato and Associates, LLC

    Miami Beach, Florida, 33139

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Chelsea Village Medical, PC

    New York, New York, 10011

  • Mt Sinai School of Medicine

    New York, New York, 10011

  • Ricky K. Hsu, MD, PC

    New York, New York, 10011

  • Saint Michaels Medical Center

    Newark, New Jersey, 07102

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • Idocf/ Valuhealthmd, Llc

    Orlando, Florida, 32806

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Division of Infectious Diseases, Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Philadelphia FIGHT

    Philadelphia, Pennsylvania, 19107

  • Spectrum Medical Group

    Phoenix, Arizona, 85012

  • University of California, Davis Medical Center

    Sacramento, California, 95817

  • Kaiser Permanente Medical Group

    Sacramento, California, 95825

  • La Playa Medical Group and Clinical Research

    San Diego, California, 92103

  • Metropolis Medical

    San Francisco, California, 94115

  • Kaiser Permanente Medical Center, Clinical Trials Unit

    San Francisco, California, 94118

  • SouthWest CARE Center

    Santa Fe, New Mexico, 87505

  • Peter Shalit, M.D.

    Seattle, Washington, 98104

  • South Jersey Infectious Disease

    Somers Point, New Jersey, 08244

  • CentralWest Clinical Research

    St Louis, Missouri, 63108

  • University of South Florida HIV Clinical Research Unit / Hillsborough County Health Department

    Tampa, Florida, 33602

  • Infectious Disease Research Institute Inc.

    Tampa, Florida, 33614

  • St. Joseph's Comprehensive Research Institute

    Tampa, Florida, 33615

  • Montefiore Medical Center - AIDS Center

    The Bronx, New York, 10467

  • Dupont Circle Physicians Group

    Washington D.C., District of Columbia, 20009

  • Whitman-Walker Clinic

    Washington D.C., District of Columbia, 20009

  • George Washington University Medical Faculty Associates

    Washington D.C., District of Columbia, 20037

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

France11 sites

  • Service des Maladies Infectieuses, CHU de Caen

    Caen, 14033

  • Hôpital de la Croix Rousse - Maladies Infectieuses et Tropicales

    Lyon, 69288

  • Hopital Sainte Marguerite Service d'Immuno-Hématologie Clinique -CISIH

    Marseille, 13009

  • CHU de Nantes Hopital de l'Hotel Dieu

    Nantes, 44093

  • Department of Infectious Diseases, Saint-Louis hospital

    Paris, 75010

  • Hopital Saint Antoine, Service De Maladies Infectieuses

    Paris, 75012

  • Bichat Hospital

    Paris, 75018

  • Tenon Hospital, UPMC

    Paris, 75020

  • Maladies Infectieuses Dpt

    Paris, 75651

  • Centre François Magendie, Hôpital du Haut Lévêque

    Pessac, 33604

  • Centre Hospitalier de Tourcoing

    Tourcoing, 59208

Other trials in France

Australia7 sites

  • Melbourne Sexual Health Centre

    Carlton, Victoria, 3053

  • St Vincent's Hospital, Sydney

    Darlinghurst, New South Wales, 2010

  • Taylor Square Private Clinic

    Darlinghurst, New South Wales, 2010

  • Alfred Hospital

    Melbourne, Victoria, 3004

  • Northside Clinic

    Melbourne, Victoria, 3068

  • Albion Street Centre

    Sydney, New South Wales, 2010

  • Holdsworth House Medical practice

    Sydney, New South Wales, 2010

Other trials in Australia

Canada7 sites

  • Clinique medicale l'Actuel

    Montreal, Quebec, H2L 4P9

  • Clinique Medicale du Quartier Latin

    Montreal, Quebec, H2L 5B1

  • Immunodeficiency Service, McGill University Health Centre (MUHC) - Montreal Chest Institute

    Montreal, Quebec, H2X 2P4

  • Project LORI

    Montreal, H3H 1V1

  • Canadian Immunodeficiency Research Collaborative (CIRC) Inc.

    Toronto, Ontario, M5B1L6

  • University Health Network, Toronto General Hospital

    Toronto, Ontario, M5G 2N2

  • Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

Brazil6 sites

  • Universidade Estadual de Campinas

    Campinas, 13083-970

  • Instituto De Pesquisa Clinica Evandro Chagas

    Rio de Janeiro, Rio de Janeiro, 21040-900

  • URDIP Faculdade de Medicina do ABC

    Santo André, São Paulo, 09060-650

  • Instituto De Infectologia Emilo Ribas

    São Paulo, São Paulo, 01246-900

  • Brasilmed Assistencia Medica E Pesquisas

    São Paulo, São Paulo, 01416-000

  • Crt-Dst/Aids

    São Paulo, São Paulo, 04121-000

Other trials in Brazil

Germany6 sites

  • EPIMED GmbH

    Berlin, 12157

  • Medizinische Universitätsklinik

    Bonn, 53127

  • University of Cologne, Department of Internal Medicine

    Cologne, 50937

  • Infektio Research GmbH / Infektiologikum Frankfurt

    Frankfurt am Main, 60311

  • ICH Study Center Hamburg

    Hamburg, 20146

  • University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit

    Hamburg, 20246

Other trials in Germany

Thailand5 sites

  • HIV-NAT, Thai Red Cross AIDS Research Center and Faculty of Medicine Chulalongkorn University

    Bangkok, 10330

  • Ramathibodi Hospital, Mahidol University

    Bangkok, 10400

  • Siriraj Hospital

    Bangkok, 10700

  • Maharaj Nakorn Chiang Mai University, Faculty of Medicine, Department of Medicine

    Chiang Mai, 50200

  • Khon Kaen University

    Khon Kaen, 40002

Other trials in Thailand

United Kingdom5 sites

  • Brighton and Sussex University Hospitals NHS Trust

    Brighton, East Sussex, BN2 1ES

  • Barts and the London NHS Trust

    London, E1 1BB

  • Homerton University Hospital

    London, E9 6SR

  • Guys and St. Thomas' NHS Trust

    London, SE1 7EH

  • Courtyard Clinic, St. Georges Hospital

    London, SW17 0QT

Other trials in United Kingdom

Italy4 sites

  • Fondazione Centro San Raffaele del Monte Tabor

    Milan, 20127

  • Azienda Ospedaliera Luigi Sacco 1° Divisione Malattie Infettive

    Milan, 20157

  • Istituto Nazionale Malattie Infettive Lazzaro Spallanzani

    Roma, 00149

  • Dipartimento di Malattie Infettive

    Torino, 10149

Other trials in Italy

Austria3 sites

  • LKH Graz West

    Graz, A-8010

  • Allgemeines Krankenhaus

    Vienna, 1090

  • Interne Lungenabteilung, SMZ Baumgartner Hoehe - Otto-Wagner-Spital

    Vienna, 1140

Other trials in Austria

Belgium3 sites

  • CHU Saint-Pierre University Hospital

    Brussels, 1000

  • Hôpital Universitaire Erasme - ULB

    Brussels, 1070

  • University of Ghent

    Ghent, 9000

Other trials in Belgium

Switzerland3 sites

  • Universitätsklinik für Infektiologie, Universitätsspital Bern

    Bern, 3010

  • CHUV

    Lausanne, Canton of Vaud, 1011

  • Division of Infectious Diseases and Hospital Hygiene; University Hospital of Zurich

    Zurich, 8091

Other trials in Switzerland

Portugal2 sites

  • Hospital de Santa Maria - CHLN

    Lisbon, 1649-035

  • Serviço de Doenças Infecciosas, Hospital de São João

    Porto, 4202-451

Other trials in Portugal

Puerto Rico2 sites

  • Instituto de Investigacion Clentifica del Sur

    Ponce, 00731

  • Clinical Research Puerto Rico

    San Juan, 00909

Other trials in Puerto Rico

Spain2 sites

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Hospital Virgen del Rocio

    Seville, 41013

Other trials in Spain

Denmark1 site

  • Rigshospitalet, Infektionsklinik 5112

    Copenhagen, 2000

Other trials in Denmark

Dominican Republic1 site

  • Instituto Dominicano de Estudios Virologicos - IDEV

    Santo Domingo

Other trials in Dominican Republic

Mexico1 site

  • Unidad de VIH, Hospital Civil de Guadalajara, Fray Antonio Alcalde

    Guadalajara, Jalisco, 44280

Other trials in Mexico

Netherlands1 site

  • Onze lieve vrouw gasthuis

    Amsterdam, 1091 AC

Other trials in Netherlands

About this study

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

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.

Conditions
HIV, HIV Infections
Being tested
COBI, RTV, ATV, FTC/TDF, COBI placebo
Keywords
Treatment Naive, HIV 1 Infected
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • COBIDrug

    Also called Tybost®, GS-9350

    Cobicistat (COBI) 150 mg tablet administered orally once daily

  • RTVDrug

    Also called Norvir®

    Ritonavir (RTV) 100 mg tablet administered orally once daily

  • ATVDrug

    Also called Reyataz®

    Atazanavir (ATV) 300 mg capsule administered orally once daily

  • FTC/TDFDrug

    Also called Truvada®

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

  • COBI placeboDrug

    Placebo to match COBI administered orally once daily

  • RTV placeboDrug

    Placebo to match RTV administered orally once daily

Study groups in NCT01108510
Study groupRoleWhat they receive
ATV+COBI+FTC/TDFExperimentalCOBI + RTV placebo + ATV + FTC/TDF once daily
Receives: Drug: COBI; Drug: ATV; Drug: FTC/TDF; Drug: RTV placebo
ATV+RTV+FTC/TDFActive comparatorRTV + COBI placebo + ATV + FTC/TDF once daily
Receives: Drug: RTV; Drug: ATV; Drug: FTC/TDF; Drug: COBI placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 48

Secondary outcomes (7)

  1. 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.

    Measured: Week 96

  2. 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.

    Measured: Week 144

  3. 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.

    Measured: Week 192

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

    Measured: Baseline to Week 48

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

    Measured: Baseline to Week 96

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

    Measured: Baseline to Week 144

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

    Measured: Baseline to Week 192

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionNov 2011
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
698 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01108510
Sponsor's protocol ID
GS-US-216-0114
Other IDs
2009-016759-22, 2009
Status last verified
Apr 2016
First submitted
20 Apr 2010
Last updated
23 May 2016
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23532097

  • 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.

    PubMed 26181707

  • 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.

    PubMed 27774892

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing COBI, RTV and ATV in people with HIV and HIV Infections, run by Gilead Sciences at 134 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 134 sites in United States, France, Australia, Canada, Brazil and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 (time frame: Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01108510, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2016.

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