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-Naïve Adults

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Gilead Sciences.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01108510
First received: April 20, 2010
Last updated: June 7, 2012
Last verified: June 2012
  Purpose

To evaluate the safety and efficacy of a regimen containing GS-9350-boosted atazanavir plus emtricitabine/tenofovir disoproxil fumarate versus ritonavir-boosted atazanavir plus emtricitabine/tenofovir disoproxil fumarate in HIV 1 infected, antiretroviral treatment-naïve adults. Development of GS-9350 as a "pharmacoenhancer" could provide a beneficial alternative to ritonavir for use in combination with protease inhibitors.


Condition Intervention Phase
HIV
HIV Infections
Drug: GS-9350 + atazanavir + emtricitabine/tenofovir DF
Drug: Comparator: ritonavir + atazanavir + emtricitabine/tenofovir DF
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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-Naïve Adults

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • The primary efficacy endpoint is the proportion of subjects that achieve HIV-1 RNA < 50 copies/mL at Week 48 [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The proportion of subjects with HIV-1 RNA < 50 copies/mL at Week 96 [ Time Frame: 96 Weeks ] [ Designated as safety issue: No ]
  • The change from baseline in CD4+ cell count at Week 48 [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
  • The change from baseline in CD4+ cell count at Week 96 [ Time Frame: 96 Weeks ] [ Designated as safety issue: No ]

Enrollment: 692
Study Start Date: April 2010
Estimated Study Completion Date: September 2014
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GS-9350 + atazanavir + emtricitabine/tenofovir DF
GS-9350 + atazanavir + emtricitabine/tenofovir disoproxil fumarate + Placebo to match ritonavir QD (n = 350)
Drug: GS-9350 + atazanavir + emtricitabine/tenofovir DF
GS-9350 150 mg + atazanavir 300 mg + emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg + Placebo to match ritonavir 100 mg QD (n = 350)
Active Comparator: ritonavir + atazanavir + emtricitabine/tenofovir DF
ritonavir + atazanavir + emtricitabine/tenofovir disoproxil fumarate + Placebo to match GS-9350 QD (n = 350)
Drug: Comparator: ritonavir + atazanavir + emtricitabine/tenofovir DF
ritonavir 100 mg + atazanavir 300 mg + emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg + Placebo to match GS-9350 150 mg QD (n = 350)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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 GS-9350, emtricitabine (FTC), tenofovir disoproxil fumarate (TDF), atazanavir (ATV), ritonavir (RTV) or subjects with any known allergies to the excipients of GS-9350 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01108510

  Hide Study Locations
Locations
United States, Arizona
Spectrum Medical Group
Phoenix, Arizona, United States, 85012
United States, Arkansas
Health for Life Clinic PLLC
Little Rock, Arkansas, United States, 72207
United States, California
Kaiser Permanente Hospital
Hayward, California, United States, 94545
Living Hope Clinical Foundation
Long Beach, California, United States, 90813
Los Angeles Gay and Lesbian Center DBA Jeffrey Goodman Special Care Clinic
Los Angeles, California, United States, 90028
Oasis Clinic
Los Angeles, California, United States, 90059
Anthony Mills MD Inc
Los Angeles, California, United States, 90069
Kenmar Research Institute, LLC
Los Angeles, California, United States, 90057
Kaiser Permanente
Los Angeles, California, United States, 90027
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Peter J Ruane, MD, Inc
Los Angeles, California, United States, 90036
Orange Coast Medical Group
Newport Beach, California, United States, 92663
East Bay AIDS Center
Oakland, California, United States, 94609
Alameda County Medical Center
Oakland, California, United States, 94602
Stanford University
Palo Alto, California, United States, 94303
University of California, Davis Medical Center
Sacramento, California, United States, 95817
Kaiser Permanente Medical Group
Sacramento, California, United States, 95825
La Playa Medical Group and Clinical Research
San Diego, California, United States, 92103
San Francisco General Hospital, University of California, San Francisco
San Francisco, California, United States, 94110
Dr. Fritz, PLC
San Francisco, California, United States, 94115
Kaiser Permanente Medical Center, Clinical Trials Unit
San Francisco, California, United States, 94118
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
National Jewish Health
Denver, Colorado, United States, 80206
Denver Infectious Disease Consultants, PLLC
Denver, Colorado, United States, 80220
United States, Connecticut
Yale University HIV Clinical Trials Program
New Haven, Connecticut, United States, 06033
The Stamford Hospital
Stamford, Connecticut, United States, 06902
United States, District of Columbia
Whitman-Walker Clinic
Washington, District of Columbia, United States, 20009
Dupont Circle Physicians Group
Washington, District of Columbia, United States, 20009
George Washington University Medical Faculty Associates
Washington, District of Columbia, United States, 20037
Capital Medical Associates, PC
Washington, District of Columbia, United States, 20036
United States, Florida
Therafirst Medical Center
Fort Lauderdale, Florida, United States, 33308
Gary J. Richmond, M.D., P.A.
Fort Lauderdale, Florida, United States, 33316
Broward Health/Comprehensive Care Center
Fort Lauderdale, Florida, United States, 33311
Midway Immunology and Research Center
Fort Pierce, Florida, United States, 34982
University of Miami School of Medicine
Miami, Florida, United States, 33136
The Kinder Medical Group
Miami, Florida, United States, 33133
Wohlfeiler, Piperato and Associates, LLC
Miami Beach, Florida, United States, 33139
Orlando Immunology Center
Orlando, Florida, United States, 32803
Idocf/ Valuhealthmd, Llc
Orlando, Florida, United States, 32806
St. Joseph's Comprehensive Research Institute
Tampa, Florida, United States, 33615
University of South Florida HIV Clinical Research Unit / Hillsborough County Health Department
Tampa, Florida, United States, 33602
Infectious Disease Research Institute Inc.
Tampa, Florida, United States, 33614
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, United States, 32960
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
Infectious Disease Solutions, PC
Atlanta, Georgia, United States, 30309
Infectious Disease Specialists of Atlanta
Decatur, Georgia, United States, 30033
Mercer University School of Medicine
Macon, Georgia, United States, 31210
United States, Hawaii
University of Hawaii - Hawaii Center for AIDS
Honolulu, Hawaii, United States, 96816
United States, Illinois
Ruth M. Rothstein CORE Center
Chicago, Illinois, United States, 60612
Howard Brown Health Center
Chicago, Illinois, United States, 60613
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21205
University of Maryland, Institute of Human Virology
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Community Research Initiative of New England
Boston, Massachusetts, United States, 02215
Boston University Medical Center
Boston, Massachusetts, United States, 02118
The Research Institute
Springfield, Massachusetts, United States, 01107
Baystate Infectious Diseases Clinical Research
Springfield, Massachusetts, United States, 01199
United States, Michigan
Be Well Medical Center
Berkley, Michigan, United States, 48072
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
United States, Missouri
CentralWest Clinical Research
St. Louis, Missouri, United States, 63108
Southampton Healthcare
St. Louis, Missouri, United States, 63139
Division of Infectious Diseases, St. Louis University Medical Center
St. Louis, Missouri, United States, 63110
United States, New Jersey
ID Care
Hillsborough, New Jersey, United States, 08844
Saint Michaels Medical Center
Newark, New Jersey, United States, 07102
South Jersey Infectious Disease
Somers Point, New Jersey, United States, 08244
United States, New Mexico
SouthWest CARE Center
Santa Fe, New Mexico, United States, 87505
United States, New York
Upstate ID Association
Albany, New York, United States, 12208
Albany Medical College
Albany, New York, United States, 12209
Montefiore Medical Center - AIDS Center
Bronx, New York, United States, 10467
Jacobi Medical Center
Bronx, New York, United States, 10461
New York Hospital Queens
Flushing, New York, United States, 11355
North Shore University Hospital
Manhasset, New York, United States, 11030
Greiger Clinic
Mount Vernon, New York, United States, 10550
Chelsea Village Medical, PC
New York, New York, United States, 10011
Ricky K. Hsu, MD, PC
New York, New York, United States, 10011
Saint Vincents Hospital Catholic Medical Center
New York, New York, United States, 10011
Beth Israel Medical Center
New York, New York, United States, 10003
Columbia University Medical Center
New York, New York, United States, 10032
AIDS Care
Rochester, New York, United States, 14604
United States, North Carolina
Carolinas Medical Center-Myers Park
Charlotte, North Carolina, United States, 28207
Duke University Medical Center
Durham, North Carolina, United States, 27710
East Carolina University, The Brody School of Medicine
Greenville, North Carolina, United States, 27834
Rosedale Infectious Diseases
Huntersville, North Carolina, United States, 28078
Wake Forest University Health Sciences
Winston Salem, North Carolina, United States, 27157
United States, Ohio
Summa Health System
Akron, Ohio, United States, 44304
United States, Pennsylvania
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States, 19107
Division of Infectious Diseases, Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
University of South Carolina
Columbia, South Carolina, United States, 29203
United States, Texas
Nicholaos C. Bellos, MD, PA
Dallas, Texas, United States, 75204
Texas Health Research & Education
Dallas, Texas, United States, 75231
Tarrant County Infectious Disease Associates
Fort Worth, Texas, United States, 76104
Valley AIDS Council
Harlingen, Texas, United States, 78550
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Gordon E. Crofoot MD PA
Houston, Texas, United States, 77098
Research Access Network
Houston, Texas, United States, 77098
Dr. Joseph C. Gathe MD
Houston, Texas, United States, 77004
DCOL Center for Clinical Research
Longview, Texas, United States, 75605
United States, Virginia
Clinical Alliance for Research & Education, Infectious Diseases (CARE-ID)
Annandale, Virginia, United States, 22003
United States, Washington
Peter Shalit, M.D.
Seattle, Washington, United States, 98104
Spokane Pulmonary and Critical Care
Spokane, Washington, United States, 99204
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Argentina
Fundacion Huesped
Buenos Aires, Argentina, C1202ABB
Hospital Teodoro Álvarez
Buenos Aires, Argentina, 1406
FUNCEI
Buenos Aires, Argentina, 1425
Fundación de ayuda al Inmunodeficiente (FUNDAI)
Buenos Aires, Argentina, 1264
Australia, New South Wales
Taylor Square Private Clinic
Darlinghurst, New South Wales, Australia, 2010
St Vincent's Hospital, Sydney
Darlinghurst, New South Wales, Australia, 2010
Holdsworth House Medical practice
Sydney, New South Wales, Australia, 2010
Albion Street Centre
Sydney, New South Wales, Australia, 2010
Australia, Victoria
Melbourne Sexual Health Centre
Carlton, Victoria, Australia, 3053
Northside Clinic
Melbourne, Victoria, Australia, 3068
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Prahran Market Clinic
Prahran, Victoria, Australia, 3181
Austria
LKH Graz West
Graz, Austria, A-8010
Allgemeines Krankenhaus
Vienna, Austria, 1090
Interne Lungenabteilung, SMZ Baumgartner Hoehe - Otto-Wagner-Spital
Vienna, Austria, 1140
Belgium
CHU Saint-Pierre University Hospital
Brussels, Belgium, 1000
Hôpital Universitaire Erasme - ULB
Brussels, Belgium, 1070
University of Ghent
Ghent, Belgium, 9000
Brazil
Instituto De Pesquisa Clinica Evandro Chagas
Rio de Janeiro, RJ, Brazil, 21040-900
URDIP Faculdade de Medicina do ABC
Santo Andre, Sao Paulo, Brazil, 09060-650
Hospital Guilherme Álvaro
Santos, São Paulo, Brazil, 11045-904
Universidade Estadual de Campinas
Campinas, Brazil, 13083-970
Crt-Dst/Aids
São Paulo, Brazil, 04121-000
Instituto De Infectologia Emilo Ribas
São Paulo, Brazil, 01246-900
Brasilmed Assistencia Medica E Pesquisas
São Paulo, Brazil, 01416-000
Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z1YG
Canada, Manitoba
Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Ontario
University Health Network, Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2
Canadian Immunodeficiency Research Collaborative (CIRC) Inc.
Toronto, Ontario, Canada, M5B1L6
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Clinique medicale l'Actuel
Montreal, Quebec, Canada, H2L 4P9
Clinique Medicale du Quartier Latin
Montreal, Quebec, Canada, H2L 5B1
Immunodeficiency Service, McGill University Health Centre (MUHC) - Montreal Chest Institute
Montréal, Quebec, Canada, H2X 2P4
Canada
Project LORI
Montreal, Canada, H3H 1V1
Denmark
Rigshospitalet, Infektionsklinik 5112
Copenhagen, Denmark, 2000
Dep Inf Dis 144, Copenhagen University Hospital, Hvidovre
Hvidovre, Denmark, 2650
Dominican Republic
Instituto Dominicano de Estudios Virologicos - IDEV
Santo Domingo, Dominican Republic
France
Service des Maladies Infectieuses, CHU de Caen
Caen, France, 14033
Hôpital Hôtel-Dieu
Lyon, France, 69288
Hopital Sainte Marguerite Service d'Immuno-Hématologie Clinique -CISIH
Marseille, France, 13009
CHU Gui de Chauliac, Maladies Infectieuses Dpt
Montpellier, France, 34295
Infectiologie - 7ème Ouest - CHU HOTEL DIEU
Nantes, France, 44093
Bichat Hospital
Paris, France, 75018
Maladies Infectieuses Dpt
Paris, France, 75651
Department of Infectious Diseases, Saint-Louis hospital
Paris, France, 75010
Tenon Hospital, UPMC
Paris, France, 75020
Hopital Saint Antoine, Service De Maladies Infectieuses
Paris, France, 75012
Centre François Magendie, Hôpital du Haut Lévêque
Pessac, France, 33604
Centre Hospitalier de Tourcoing
Tourcoing, France, 59208
Germany
EPIMED GmbH
Berlin, Germany, 12157
Medizinische Universitätsklinik
Bonn, Germany, 53127
Infektio Research GmbH / Infektiologikum Frankfurt
Frankfurt am Main, Germany, 60311
Klinikum der Goethe-Universitaet, Medizinische Klinik II, Schwerpunkt HIV, Haus 68
Frankfurt am Main, Germany, 60590
ICH Study Center Hamburg
Hamburg, Germany, 20146
University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit
Hamburg, Germany, 20246
University of Cologne, Department of Internal Medicine
Koln, Germany, 50937
Italy
Ospedali Riuniti
Bergamo, Italy, 24128
Institute of infectious diseases - University of Brescia
Brescia, Italy, 25124
Clinic of Infectious and Tropical Diseases, San Paolo Hospital, University of Milan
Milan, Italy, 20142
Fondazione Centro San Raffaele del Monte Tabor
Milan, Italy, 20127
Azienda Ospedaliera Luigi Sacco 1° Divisione Malattie Infettive
Milano, Italy, 20157
Clinica Malattie Infettive Tropicali; Azienda Ospedaliero-Universitaria Policlinico di Modena
Modena, Italy, 41100
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.
Roma, Italy, 00149
Dipartimento di Malattie Infettive
Torino, Italy, 10149
Mexico
Hospital General Regional de Leon
Leon, Guanajuato, Mexico, 37320
Unidad de VIH, Hospital Civil de Guadalajara, Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico, 44280
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zublran
Mexico, Mexico, 14000
Hospital Central "Dr. Ignacio Morones Prieto"
San Luis Potosi, Mexico, 78240
Netherlands
Onze lieve vrouw gasthuis
Amsterdam, Netherlands, 1091 AC
Erasmus MC, Internal Medicine, Section of Infectious Diseases
Rotterdam, Netherlands, 3000 CA
Portugal
Hospital de Santa Maria - CHLN
Lisbon, Portugal, 1649-035
Centro Hospitalar de Lisboa Ocidental - Hospital dos Capuchos
Lisbon, Portugal, 1150-069
Serviço de Doenças Infecciosas, Hospital de São João
Porto, Portugal, 4202-451
Puerto Rico
Instituto de Investigacion Clentifica del Sur
Ponce, Puerto Rico, 00731
Clinical Research Puerto Rico
San Juan, Puerto Rico, 00909
VA Caribbean Healthcare System
San Juan, Puerto Rico, 00921
HOPE Clinical Research
San Juan, Puerto Rico, 00909
Spain
Hospital Universitario Principe de Asturias
Alcalá de Henares, Spain, 28805
Hospital Germans Trias i Pujol
Badalona, Spain, 8916
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 8025
Hospital Clinic i Provincial
Barcelona, Spain, 8036
Hospital Reina Sofia
Córdoba, Spain, 14004
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Hospital Ramon y Cajal
Madrid, Spain, 28034
Hospital Universitario Doce de Octubre
Madrid, Spain, 28041
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Virgen del Rocio
Sevilla, Spain, 41013
Complejo Hospitalario Xeral-Cies
Vigo, Spain, 36204
Sweden
Department of Infectious Diseases
Stockholm, Sweden, 14186
Venhälsan, Södersjukhuset
Stockholm, Sweden, 11883
Switzerland
CHUV
Lausanne, VD, Switzerland, 1011
Universitätsklinik für Infektiologie, Universitätsspital Bern
Bern, Switzerland, 3010
Division of Infectious Diseases and Hospital Hygiene; University Hospital of Zurich
Zürich, Switzerland, 8091
Thailand
HIV-NAT, Thai Red Cross AIDS Research Center and Faculty of Medicine Chulalongkorn University
Bangkok, Thailand, 10330
Ramathibodi Hospital, Mahidol University
Bangkok, Thailand, 10400
Siriraj Hospital
Bangkok, Thailand, 10700
Maharaj Nakorn Chiang Mai University, Faculty of Medicine, Department of Medicine
Chiang Mai, Thailand, 50200
Khon Kaen University
Khon Kaen, Thailand, 40002
United Kingdom
Brighton and Sussex University Hospitals NHS Trust
Brighton, East Sussex, United Kingdom, BN2 1ES
Homerton University Hospital
London, United Kingdom, E9 6SR
Chelsea & Westminster Hospital
London, United Kingdom, SW10 9TH
Guys and St. Thomas' NHS Trust
London, United Kingdom, SE1 7EH
St. Mary's Hospital, London (Imperial College, London)
London, United Kingdom, W2 1NY
Barts and the London NHS Trust
London, United Kingdom, E1 1BB
Courtyard Clinic, St. Georges Hospital
London, United Kingdom, SW17 0QT
North Manchester General Hospital
Manchester, United Kingdom, M8 5RB
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Huyen Cao, MD Gilead Sciences
  More Information

No publications provided by Gilead Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01108510     History of Changes
Other Study ID Numbers: GS-US-216-0114
Study First Received: April 20, 2010
Last Updated: June 7, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Treatment Naive
HIV 1 Infected

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Tenofovir disoproxil
Tenofovir
Atazanavir
Ritonavir
Emtricitabine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents
HIV Protease Inhibitors
Protease Inhibitors

ClinicalTrials.gov processed this record on October 19, 2014