Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Disoproxil Fumarate in HIV-1 Positive, Antiretroviral Treatment-Naïve Adults

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01780506
First received: January 16, 2013
Last updated: December 24, 2013
Last verified: December 2013
  Purpose

This study is to evaluate the efficacy of a single-tablet regimen (STR)containing elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) versus a STR containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) in HIV-1 positive, antiretroviral treatment-naive adults as determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 48.


Condition Intervention Phase
HIV
HIV Infections
Drug: E/C/F/TAF
Drug: E/C/F/TDF
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 Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Disoproxil Fumarate in HIV-1 Positive, Antiretroviral Treatment-Naïve Adults

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Proportion of participants achieving HIV-1 RNA < 50 copies/mL [ Time Frame: Week 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent change from baseline in hip bone mineral density (BMD) [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
  • Percent change from baseline in spine BMD [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
  • Change from baseline in serum creatinine at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
  • Incidence of treatment-emergent proteinuria [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: No ]
    Incidence of treatment-emergent proteinuria through Week 48 will be summarized.

  • Proportion of participants with HIV-1 RNA < 50 copies/mL at Week 96 [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • Proportion of participants with HIV-1 RNA < 20 copies/mL [ Time Frame: Weeks 48 and 96 ] [ Designated as safety issue: No ]
  • Change from baseline in CD4+ cell count [ Time Frame: Weeks 48 and 96 ] [ Designated as safety issue: No ]
  • Percent change from baseline in hip and spine BMD at Week 96 [ Time Frame: Week 96 ] [ Designated as safety issue: Yes ]
  • Change from baseline in serum creatinine at Week 96 [ Time Frame: Week 96 ] [ Designated as safety issue: Yes ]
  • Incidence of treatment-emergent proteinuria through Week 96 [ Time Frame: Baseline to Week 96 ] [ Designated as safety issue: No ]
    Incidence of treatment-emergent proteinuria through Week 96 will be summarized.

  • Urine retinol binding protein (RBP) to creatinine ratio [ Time Frame: Weeks 48 and 96 ] [ Designated as safety issue: No ]
  • Urine beta-2-microglobulin to creatinine ratio [ Time Frame: Weeks 48 and 96 ] [ Designated as safety issue: No ]

Estimated Enrollment: 840
Study Start Date: December 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: E/C/F/TAF
E/C/F/TAF single-tablet regimen (STR) plus placebo to match E/C/F/TDF for 96 weeks
Drug: E/C/F/TAF
Elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg (E/C/F/TAF) administered orally once daily
Active Comparator: E/C/F/TDF
E/C/F/TDF STR plus placebo to match E/C/F/TAF for 96 weeks
Drug: E/C/F/TDF
Elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg (E/C/F/TDF) administered orally once daily
Other Name: Stribild®

  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 ≥ 1,000 copies/mL at screening
  • No prior use of any approved or investigational antiretroviral drug for any length of time, except the use for pre-exposure prophylaxis (PREP), post-exposure prophylaxis (PEP), or treatment during pregnancy, up to 6 months prior to screening
  • Screening genotype report must show sensitivity to elvitegravir, emtricitabine, tenofovir disoproxil fumarate (tenofovir DF)
  • Normal electrocardiogram (ECG)
  • Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance
  • Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
  • Adequate hematologic function
  • Serum amylase ≤ 5 × ULN
  • Male subjects and females of childbearing potential must agree to utilize highly effective contraception methods or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment and for 30 days following the last dose of study drug
  • Female subjects who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing
  • Female subjects who have stopped menstruating for ≥ 12 months but do not have documentation of ovarian hormonal failure must have a serum follicle stimulating hormone (FSH) level at screening within the post-menopausal range based on the Central Laboratory reference range
  • Age ≥ 18 years

Exclusion Criteria:

  • A new acquired immunodeficiency syndrome (AIDS) defining condition diagnosed within the 30 days prior to screening
  • Hepatitis B surface antigen (HBsAg) positive
  • Hepatitis C antibody positive
  • Subjects experiencing decompensated cirrhosis
  • Females who are breastfeeding
  • Positive serum pregnancy test
  • Have an implanted defibrillator or pacemaker
  • Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance
  • History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma
  • Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
  • 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 dosing requirements
  • Participation in any other clinical trial (including observational trials) without prior approval
  • Subjects receiving ongoing therapy with drugs not to be used with elvitegravir, cobicistat, emtricitabine, tenofovir DF, and TAF or subjects with any known allergies to the excipients of E/C/F/TDF or E/C/F/TAF single-tablet regimen tablets
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01780506

  Hide Study Locations
Locations
United States, Alabama
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Spectrum Medical Group
Phoenix, Arizona, United States, 85012
United States, California
Kaiser Permanente
Hayward, California, United States, 94545
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Anthony Mills MD Inc
Los Angeles, California, United States, 90069
Peter J. Ruane, MD, Inc.
Los Angeles, California, United States, 90036
Kaiser Permanente Los Angeles
Los Angeles, California, United States, 90027
University of California, Los Angeles
Los Angeles, California, United States, 90035
East Bay AIDS Center
Oakland, California, United States, 94609
Alameda County Medical Center
Oakland, California, United States, 94602
Eisenhower Medical Associates
Palm Springs, California, United States, 92264
Stanford University
Palo Alto, California, United States, 94304
Kaiser Permanente - Sacramento
Sacramento, California, United States, 95825
La Playa Medical Group and Clinical Research
San Diego, California, United States, 92103
Kaiser Permanente Medical Center
San Francisco, California, United States, 94118
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, United States, 90502
United States, Colorado
Apex Research, LLC
Denver, Colorado, United States, 80209
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Whitman Walker Clinic
Washington, District of Columbia, United States, 20009
Capital Medical Associates, P.C.
Washington, District of Columbia, United States, 20036
Medical Faculty Associates, Inc.
Washington, District of Columbia, United States, 20037
Dupont Circle Physicians Group, P.C.
Washington, District of Columbia, United States, 20009
United States, Florida
Gary Richmond, MD, PA, Inc.
Fort Lauderdale, Florida, United States, 33316
Midway Immunology & Research Center, LLC
Fort Pierce, Florida, United States, 34982
TheraFirst Medical Center
Ft. Lauderdale, Florida, United States, 33308
The Kinder Medical Group
Miami, Florida, United States, 33133
AIDS Healthcare Foundation
Miami Beach, Florida, United States, 33139
Orlando Immunology Center
Orlando, Florida, United States, 32803
IDOCF/ValuHealthMD, LLC
Orlando, Florida, United States, 32806
Infectious Diseases Associates
Pensacola, Florida, United States, 32504
St. Joseph's Comprenhensive Research Inisitute
Tampa, Florida, United States, 33614
The University of South Florida
Tampa, Florida, United States, 33602
Infectious Disease Research Institute Inc.
Tampa, Florida, United States, 33614
AIDS Research and Treatment Center of the Treasure Coast
Vero Beach, Florida, United States, 32960
Triple O Research Institute PA
West Palm Beach, Florida, United States, 33401
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
Emory University
Atlanta, Georgia, United States, 30308
Atlanta ID Group, PC
Atlanta, Georgia, United States, 30309
Georgia Regents University
Augusta, Georgia, United States, 30912
Infectious Disease Specialist of Atlanta
Decatur, Georgia, United States, 30033
Mercer University School of Medicine
Macon, Georgia, United States, 31201
United States, Hawaii
University of Hawaii - Hawaii Center for AIDS
Honolulu, Hawaii, United States, 96816
United States, Illinois
Howard Brown Health Center
Chicago, Illinois, United States, 60613
Ruth M. Rothstein CORE Center
Chicago, Illinois, United States, 60612
Carolinas Medical Center--Myers Park Infectious Disease Clinic
Chicago, Illinois, United States, 60612
Northwestern University
Chicago, Illinois, United States, 60611
Rush University Medical Center, Section of Infectious Diseases
Chicago, Illinois, United States, 60305
United States, Maryland
Institute of Human Virology, University of Maryland
Baltimore, Maryland, United States, 21201
Johns Hopkins University
Lutherville, Maryland, United States, 21093
United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118
Community Research Initative
Boston, Massachusetts, United States, 02111
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Metrowest Medical Center
Framingham, Massachusetts, United States, 01702
The Research Institute
Springfield, Massachusetts, United States, 01105
United States, Michigan
Be Well Medical Center
Berkley, Michigan, United States, 48072
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
United States, Missouri
Central West Clinical Research, Inc.
St Louis, Missouri, United States, 63108
Southampton Healthcare, Inc.
St Louis, Missouri, United States, 63139
Saint Louis University
St. Louis, Missouri, United States, 63110
United States, New Jersey
ID Care
Hillsborough, New Jersey, United States, 08844
Saint Michael's Medical Center
Newark, New Jersey, United States, 07102
South Jersey Infectious Disease
Somers Point, New Jersey, United States, 08244
United States, New Mexico
Southwest C.A.R.E. Center
Santa Fe, New Mexico, United States, 87505
United States, New York
Albany Medical College
Albany, New York, United States, 12208
Upstate Infectious Diseases Associates
Albany, New York, United States, 12208
Montefiore Medical Center
Bronx, New York, United States, 10467
New York Hospital Queens
Flushing, New York, United States, 11355
North Shore University Hospital - Division of Infectious Diseases
Manhasset, New York, United States, 11030
Greiger Clinic
Mount Vernon, New York, United States, 10550
Chelsea Village Medical
New York, New York, United States, 10011
New York University School of Medicine
New York, New York, United States, 10016
Mount Sinai School of Medicine
New York, New York, United States, 10029
AIDS Care
Rochester, New York, United States, 14607
Jacobi Medical Center
South Bronx, New York, United States, 10461
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27514
Infectious Disease Consultants, PA
Charlotte, North Carolina, United States, 28209
Carolinas Medical Center Myer's Park Clinic
Charlotte, North Carolina, United States, 28207
Duke University
Durham, North Carolina, United States, 22710
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 Care Center
Akron, Ohio, United States, 44304
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02906
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
University of South Carolina School of Medicine
Columbia, South Carolina, United States, 29203
United States, Texas
Central Texas Clinical Research
Austin, Texas, United States, 78705
St. Hope Foundation, Inc.
Bellaire, Texas, United States, 77401
Trinity Health and Wellness Center/AIDS Arms, Inc.
Dallas, Texas, United States, 75208
North Texas Infectious Diseases Consultants
Dallas, Texas, United States, 75246
Southwest Infectious Disease Clinical Research, Inc.
Dallas, Texas, United States, 75219
Tarrant County Infectious Disease Associates
Fort Worth, Texas, United States, 76104
Garcias' Family Health Group
Harlingen, Texas, United States, 78550
Gordon E. Crofoot, MD, PA
Houston, Texas, United States, 77098
Therapeutic Concepts, PA
Houston, Texas, United States, 77004
Research Access Network
Houston, Texas, United States, 77098
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
DCOL Center for Clinical Research
Longview, Texas, United States, 75605
United States, Virginia
Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)
Annandale, Virginia, United States, 22003
United States, Washington
Peter Shalit, MD
Seattle, Washington, United States, 98104
Rockwood Pulmonary and Critical Care
Spokane, Washington, United States, 99204
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Australia, New South Wales
Holdsworth House Medical Practice
Darlinghurst, New South Wales, Australia, 2010
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia, 2010
East Sydney Doctors
Sydney, New South Wales, Australia, 2010 NSW
Albion Street Centre
Sydney, New South Wales, Australia, 2010
Australia, Victoria
Melbourne Sexual Health Clinic
Carlton, Victoria, Australia, 3053
Austria
Innsbruck Medical University, Dept of Dermatology and Venereology
Innsbruck, Austria, A6020
DIAID, Department of Dermatology, Medical University Vienna
Vienna, Austria, 1090
Otto-Wagner-Spital, Sozialmedizinisches Zentrum Baumgartner Hoehe
Wien, Austria, 1140
Belgium
Hôpital Erasme-ULB
Anderlecht, Brussels, Belgium, 1070
Maladies Infectieuses et Tropicales
Brussels, Belgium, 1200
CHU Saint-Pierre University Hospital
Brussels, Belgium, 1000
University Hospitals Leuven
Leuven, Belgium, 3000
Brazil
UPCAids-UNICAMP
Campinas, Brazil, 13083 888
Universidade Federal do Rio de Janeiro
Campinas, Brazil, 13083 888
Instituto de Pesquisa Clínica Evandro Chagas - Fundaçã
Rio de Janeiro, Brazil, 21046-900
Faculdade de Medicina do ABC
Santo Andre, Brazil, 00960-650
Hospital Guilherme Alvaro
Santos, Brazil, 11045-904
Faculdade de Medicina da Universidade de Sao Paulo
Sao Paulo, Brazil, 04038-034
Instituto de Infectologia Emillo Ribas
Sao Paulo, Brazil, 01246-900
Centro de Referência e Treinamento DST/AIDS
São Paulo, Brazil, 04121-000
Canada, British Columbia
Spectrum Health
Vancouver, British Columbia, Canada, V6Z 2T1
Canada, Manitoba
Health Sciences Centre Winnipeg
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Maple Leaf Research
Toronto, Ontario, Canada, M5G 1K2
University Health Network/Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2
Canada, Quebec
Clinique Medicale Du Quartier Latin
Montreal, Quebec, Canada, H2L 5B1
Clinique OPUS
Montreal, Quebec, Canada, H3A 1T1
Clinique medicale l'Actuel
Montreal, Quebec, Canada, H2L 5B1
Canada
Research Institute of HUHC
Montreal, Canada, H2X 2P4
Sunnybrook Health Science Center
Toronto, Canada, M4N 3M5
Dominican Republic
Instituto Dominicano de Estudio Virologicos - IDEV
Santo Domingo, Dominican Republic, 10103
France
CHU Bicetre
Le Kremlin-Bicêtre, France, 94275
Hôpital de la Croix Rousse
Lyon Cedex 4, France, 69317
University Hospital of Montpellier (CHU-Gui de Chauliac)
Montpelier Cedex 5, France, 34295
Centre Hospitalier Universitaire de Nice
Nice, France, 06202
Hôpital Bichat Claude Bernard
Paris, France, 75018
Hopital Saint Louis
Paris Cedex 10, France, 75010
Hopital Saint Antoine
Paris Cedex 12, France, 75571
Hopital Pitie-Salpetriere
Paris Cedex 13, France, 75651
Hopital Tenon
Paris Cedex 20, France, 75970
Ch Tourcoing
Toulon, France, 83056
Germany
Epimed GmbH
Berlin, Germany, 12157
University of Bonn
Bonn, Germany, 53127
Center for HIV and Hepatogastroenterology
Duesseldorf, Germany, 40237
Universitätsklinikum Essen
Essen, Germany, 45122
Infektio Research GmbH & CoKG
Frankfurt, Germany, 60311
Universitätsklinikum Hamburg-Eppendorf, Ambulanzzentrum des UKE GmbH, Infektiologie
Hamburg, Germany, 20246
ICH Study Center Hamburg
Hamburg, Germany, 20146
Medizinische Hochschule Hannover
Hannover, Germany, 30625
University of Cologne, Department of Internal Medicine
Koln, Germany, 50937
MUC Research GmbH
München, Germany, 80335
Italy
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
Bologna, Italy, 40138
Azienda Ospedaliera - Polo Universitario Ospedale San Paolo
Milano, Italy, 20142
Divisione Clinicizzata di Malattie Infettive Universita degli Studi
Milano, Italy, 20157
Ospedale San Raffaele
Milano, Italy, 20127
University of Modena and Reggio Emilia
Modena, Italy, 41100
Foundation San Matteo Hospital
Pavia, Italy, 27100
Japan
National Center for Global Health and Medicine AIDS Clinical Center
Shinjuku-ku, Tokyo, Japan, 162-8655
Mexico
Hospital Civil de Guadalajara
Guadalajara, Mexico, 44280
Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands, 1091 AC
Erasmus MC
Rotterdam, Netherlands, 3000CA
Portugal
Servico de Doencas Infecciosas
Coimbra, Portugal, 3000-075
Centro Hospitalar Lisboa Central - Hospital Capuchos
Lisboa, Portugal, 1160-050
Hospital de Santa Maria
Lisbon, Portugal, 1649-035
Centro Hospitalar do Porto - Hospital Joaquim Urbano
Porto, Portugal, 4350-086
Puerto Rico
Ararat Research Center
Ponce, Puerto Rico, 00717
University of Puerto Rico School of Medicine
San Juan, Puerto Rico, 00935
HOPE Clinical Research
San Juan, Puerto Rico, 00909
Spain
Hospital Germans Trias i Pujol
Badalona, Spain, 08916
Hospital Clinic i Provincial
Barcelona, Spain, 08036
Hospital Universitari Vall D'Hebron
Barcelona, Spain, 08035
Hospital del Mar
Barcelona, Spain, 08003
University Hospital Bellvitge
Barcelona, Spain, 08907
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital General Universitario Gregorio Maranon
Madrid, Spain, 28007
Complejo Hospitalario Universitario de Santiago (CHUS)
Santiago de Compostela, Spain, 15706
Sweden
Venhälsan, Södersjukhuset
Stockholm, Sweden, 11883
Karolinska Institutet
Stockholm, Sweden, 14186
Switzerland
Universitätsspital Bern
Berne, Switzerland, 3010
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, 1011
University Hospital, Zurich
Zurich, Switzerland, CH-8091
Thailand
The HIV Netherland Australia Thailand, Thai Red Cross AIDS Research Center (The HIV-NAT)
Bangkok, Thailand, 10330
Siriraj Hospital
Bangkok, Thailand, 10700
Ramathibodi Hospital, Mahidol University
Bangkok, Thailand, 10400
Khon Kaen University
Khon Kaen, Thailand, 40002
United Kingdom
Whittall Street Clinic
Birmingham, United Kingdom, B4 6DH
Brighton and Sussex University Hospitals NHS Trust
Brighton, United Kingdom, BN2 3EW
Brownlee Centre, Gartnavel General Hospital
Glasgow, United Kingdom, G12OYN
The Royal Free Hampstead NHS Trust
London, United Kingdom, NW3 2QG
Barts & The London NHS Trust
London, United Kingdom, E1 1BB
King's College Hospital
London, United Kingdom, SE5 9RJ
Chelsea & Westminster Hospital
London, United Kingdom, SW10 9TH
Mortimer Market Centre
London, United Kingdom, WC1E 6JB
North Manchester General Hospital
Manchester, United Kingdom, M8 5RB
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Marshall Fordyce, MD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01780506     History of Changes
Other Study ID Numbers: GS-US-292-0104, 2012-004458-27
Study First Received: January 16, 2013
Last Updated: December 24, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
HIV
Treatment Naive
HIV 1 Infected
Female
Women

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
Tenofovir disoproxil
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

ClinicalTrials.gov processed this record on April 17, 2014