DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Gilead Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV; HIV Infections

Intervention: COBI (Drug); RTV (Drug); ATV (Drug); FTC/TDF (Drug); Placebo to match COBI (Drug); Placebo to match RTV (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Gilead Sciences

Official(s) and/or principal investigator(s):
Huyen Cao, MD, Study Director, Affiliation: Gilead Sciences

Summary

This study is designed to evaluate the safety and efficacy of a regimen containing Cobicistat (COBI)-boosted atazanavir (ATV/co) plus emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus ritonavir (RTV)-boosted atazanavir (ATV/r) plus FTC/TDF in HIV-1-infected, antiretroviral treatment-naive adults. Development of COBI as a "pharmacoenhancer" could provide a beneficial alternative to RTV for use in combination with protease inhibitors.

Clinical Details

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-Nave Adults

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48

Secondary outcome: Change From Baseline in CD4 Cell Count at Week 48

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 day s 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.

Locations and Contacts

LKH Graz West, Graz A-8010, Austria

Allgemeines Krankenhaus, Vienna 1090, Austria

Interne Lungenabteilung, SMZ Baumgartner Hoehe - Otto-Wagner-Spital, Vienna 1140, Austria

CHU Saint-Pierre University Hospital, Brussels 1000, Belgium

Hôpital Universitaire Erasme - ULB, Brussels 1070, Belgium

University of Ghent, Ghent 9000, Belgium

Universidade Estadual de Campinas, Campinas 13083-970, Brazil

Brasilmed Assistencia Medica E Pesquisas, São Paulo 01416-000, Brazil

Crt-Dst/Aids, São Paulo 04121-000, Brazil

Instituto De Infectologia Emilo Ribas, São Paulo 01246-900, Brazil

Project LORI, Montreal H3H 1V1, Canada

Rigshospitalet, Infektionsklinik 5112, Copenhagen 2000, Denmark

Instituto Dominicano de Estudios Virologicos - IDEV, Santo Domingo, Dominican Republic

Service des Maladies Infectieuses, CHU de Caen, Caen 14033, France

Hôpital de la Croix Rousse - Maladies Infectieuses et Tropicales, Lyon 69288, France

Hopital Sainte Marguerite Service d'Immuno-Hématologie Clinique -CISIH, Marseille 13009, France

CHU de Nantes Hopital de l'Hotel Dieu, Nantes 44093, France

Bichat Hospital, Paris 75018, France

Department of Infectious Diseases, Saint-Louis hospital, Paris 75010, France

Hopital Saint Antoine, Service De Maladies Infectieuses, Paris 75012, France

Maladies Infectieuses Dpt, Paris 75651, France

Tenon Hospital, UPMC, Paris 75020, France

Centre François Magendie, Hôpital du Haut Lévêque, Pessac 33604, France

Centre Hospitalier de Tourcoing, Tourcoing 59208, France

EPIMED GmbH, Berlin 12157, Germany

Medizinische Universitätsklinik, Bonn 53127, Germany

Infektio Research GmbH / Infektiologikum Frankfurt, Frankfurt am Main 60311, Germany

ICH Study Center Hamburg, Hamburg 20146, Germany

University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit, Hamburg 20246, Germany

University of Cologne, Department of Internal Medicine, Koln 50937, Germany

Azienda Ospedaliera Luigi Sacco 1° Divisione Malattie Infettive, Milano 20157, Italy

Fondazione Centro San Raffaele del Monte Tabor, Milan 20127, Italy

Istituto Nazionale Malattie Infettive Lazzaro Spallanzani, Roma 00149, Italy

Dipartimento di Malattie Infettive, Torino 10149, Italy

Onze lieve vrouw gasthuis, Amsterdam 1091 AC, Netherlands

Hospital de Santa Maria - CHLN, Lisbon 1649-035, Portugal

Serviço de Doenças Infecciosas, Hospital de São João, Porto 4202-451, Portugal

Instituto de Investigacion Clentifica del Sur, Ponce 00731, Puerto Rico

Clinical Research Puerto Rico, San Juan 00909, Puerto Rico

Hospital General Universitario Gregorio Marañon, Madrid 28007, Spain

Hospital Virgen del Rocio, Sevilla 41013, Spain

Universitätsklinik für Infektiologie, Universitätsspital Bern, Bern 3010, Switzerland

Division of Infectious Diseases and Hospital Hygiene; University Hospital of Zurich, Zürich 8091, Switzerland

HIV-NAT, Thai Red Cross AIDS Research Center and Faculty of Medicine Chulalongkorn University, Bangkok 10330, Thailand

Ramathibodi Hospital, Mahidol University, Bangkok 10400, Thailand

Siriraj Hospital, Bangkok 10700, Thailand

Maharaj Nakorn Chiang Mai University, Faculty of Medicine, Department of Medicine, Chiang Mai 50200, Thailand

Khon Kaen University, Khon Kaen 40002, Thailand

Barts and the London NHS Trust, London E1 1BB, United Kingdom

Courtyard Clinic, St. Georges Hospital, London SW17 0QT, United Kingdom

Guys and St. Thomas' NHS Trust, London SE1 7EH, United Kingdom

Homerton University Hospital, London E9 6SR, United Kingdom

University of Alabama at Birmingham, Birmingham, Alabama 35294, United States

Spectrum Medical Group, Phoenix, Arizona 85012, United States

Health for Life Clinic PLLC, Little Rock, Arkansas 72207, United States

Living Hope Clinical Foundation, Long Beach, California 90813, United States

Anthony Mills MD Inc, Los Angeles, California 90069, United States

Kaiser Permanente, Los Angeles, California 90027, United States

Los Angeles Gay and Lesbian Center DBA Jeffrey Goodman Special Care Clinic, Los Angeles, California 90028, United States

Oasis Clinic, Los Angeles, California 90059, United States

Peter J Ruane, MD, Inc, Los Angeles, California 90036, United States

Kaiser Permanente Medical Group, Sacramento, California 95825, United States

University of California, Davis Medical Center, Sacramento, California 95817, United States

La Playa Medical Group and Clinical Research, San Diego, California 92103, United States

Kaiser Permanente Medical Center, Clinical Trials Unit, San Francisco, California 94118, United States

Metropolis Medical, San Francisco, California 94115, United States

Apex Research, LLC, Denver, Colorado 80220, United States

Dupont Circle Physicians Group, Washington, District of Columbia 20009, United States

George Washington University Medical Faculty Associates, Washington, District of Columbia 20037, United States

Whitman-Walker Clinic, Washington, District of Columbia 20009, United States

Brighton and Sussex University Hospitals NHS Trust, Brighton, East Sussex BN2 1ES, United Kingdom

Broward Health/Comprehensive Care Center, Fort Lauderdale, Florida 33311, United States

Therafirst Medical Center, Fort Lauderdale, Florida 33308, United States

Midway Immunology and Research Center, Fort Pierce, Florida 34982, United States

Wohlfeiler, Piperato and Associates, LLC, Miami Beach, Florida 33139, United States

The Kinder Medical Group, Miami, Florida 33133, United States

University of Miami School of Medicine, Miami, Florida 33136, United States

Idocf/ Valuhealthmd, Llc, Orlando, Florida 32806, United States

Orlando Immunology Center, Orlando, Florida 32803, United States

Infectious Disease Research Institute Inc., Tampa, Florida 33614, United States

St. Joseph's Comprehensive Research Institute, Tampa, Florida 33615, United States

University of South Florida HIV Clinical Research Unit / Hillsborough County Health Department, Tampa, Florida 33602, United States

Infectious Disease Specialists of Atlanta, Decatur, Georgia 30033, United States

Mercer University School of Medicine, Macon, Georgia 31210, United States

Howard Brown Health Center, Chicago, Illinois 60613, United States

Unidad de VIH, Hospital Civil de Guadalajara, Fray Antonio Alcalde, Guadalajara, Jalisco 44280, Mexico

Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg, Winnipeg, Manitoba R3A 1R9, Canada

Johns Hopkins University School of Medicine, Baltimore, Maryland 21205, United States

Community Research Initiative of New England, Boston, Massachusetts 02215, United States

Be Well Medical Center, Berkley, Michigan 48072, United States

Henry Ford Health System, Detroit, Michigan 48202, United States

Hennepin County Medical Center, Minneapolis, Minnesota 55415, United States

CentralWest Clinical Research, St. Louis, Missouri 63108, United States

Saint Michaels Medical Center, Newark, New Jersey 07102, United States

South Jersey Infectious Disease, Somers Point, New Jersey 08244, United States

SouthWest CARE Center, Santa Fe, New Mexico 87505, United States

St Vincent's Hospital, Sydney, Darlinghurst, New South Wales 2010, Australia

Taylor Square Private Clinic, Darlinghurst, New South Wales 2010, Australia

Albion Street Centre, Sydney, New South Wales 2010, Australia

Holdsworth House Medical practice, Sydney, New South Wales 2010, Australia

Montefiore Medical Center - AIDS Center, Bronx, New York 10467, United States

North Shore University Hospital, Manhasset, New York 11030, United States

Chelsea Village Medical, PC, New York, New York 10011, United States

Mt Sinai School of Medicine, New York, New York 10011, United States

Ricky K. Hsu, MD, PC, New York, New York 10011, United States

Carolinas Medical Center-Myers Park, Charlotte, North Carolina 28207, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

East Carolina University, The Brody School of Medicine, Greenville, North Carolina 27834, United States

Rosedale Infectious Diseases, Huntersville, North Carolina 28078, United States

Wake Forest University Health Sciences, Winston Salem, North Carolina 27157, United States

Canadian Immunodeficiency Research Collaborative (CIRC) Inc., Toronto, Ontario M5B1L6, Canada

University Health Network, Toronto General Hospital, Toronto, Ontario M5G 2N2, Canada

Division of Infectious Diseases, Thomas Jefferson University, Philadelphia, Pennsylvania 19107, United States

Philadelphia FIGHT, Philadelphia, Pennsylvania 19107, United States

University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States

Clinique Medicale du Quartier Latin, Montreal, Quebec H2L 5B1, Canada

Clinique medicale l'Actuel, Montreal, Quebec H2L 4P9, Canada

Immunodeficiency Service, McGill University Health Centre (MUHC) - Montreal Chest Institute, Montréal, Quebec H2X 2P4, Canada

Instituto De Pesquisa Clinica Evandro Chagas, Rio de Janeiro, RJ 21040-900, Brazil

URDIP Faculdade de Medicina do ABC, Santo Andre, Sao Paulo 09060-650, Brazil

University of South Carolina, Columbia, South Carolina 29203, United States

Southwest Infectious Disease Clinical Research, Inc., Dallas, Texas 75204, United States

Tarrant County Infectious Disease Associates, Fort Worth, Texas 76104, United States

Garcia's Family Health Group, Harlingen, Texas 78550, United States

Gordon E. Crofoot MD PA, Houston, Texas 77098, United States

Research Access Network, Houston, Texas 77098, United States

Therapeutic Concepts, PA, Houston, Texas 77004, United States

DCOL Center for Clinical Research, Longview, Texas 75605, United States

CHUV, Lausanne, VD 1011, Switzerland

Melbourne Sexual Health Centre, Carlton, Victoria 3053, Australia

Alfred Hospital, Melbourne, Victoria 3004, Australia

Northside Clinic, Melbourne, Victoria 3068, Australia

Peter Shalit, M.D., Seattle, Washington 98104, United States

Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States

Additional Information

Starting date: April 2010
Last updated: May 8, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017