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 currently recruiting participants.
Verified May 2013 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01780506
First received: January 16, 2013
Last updated: May 7, 2013
Last verified: May 2013
  Purpose

The purpose of 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 naïve adult subjects as determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 48.


Condition Intervention Phase
HIV
HIV Infections
Drug: elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide
Drug: elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate
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:
  • The proportion of subjects who have HIV-1 RNA < 50 copies/mL [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
    The primary efficacy endpoint is determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 48


Secondary Outcome Measures:
  • The proportion of subjects with HIV-RNA <20 and <200 copies/mL at Weeks 48 and 96 [ Time Frame: Week 48 and 96 ] [ Designated as safety issue: No ]
    The proportion of subjects with HIV-RNA <20 and <200 copies/mL at Weeks 48 and 96 as defined by FDA snapshot analysis

  • Change from Baseline in CD4+ cell count at Weeks 48 and 96 [ Time Frame: Weeks 48 and 96 ] [ Designated as safety issue: No ]
    The change from Baseline in CD4+ cell count at Weeks 48 and 96


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: elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide
Single tablet regimen of elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/ tenofovir alafenamide 10 mg (E/C/F/TAF) with Placebo to match single-tablet regiment of elvitegravir 150 mg/cobicistat 150 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg (E/C/F/TDF) for 96 weeks
Drug: elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide
Elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/ tenofovir alafenamide 10 mg(E/C/F/TAF) + Placebo to match single tablet regimen of elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (E/C/F/TDF) administered orally QD
Active Comparator: elvitegravir/cobicistat/emtricitabine/tenofovir DF
Single-tablet regimen of elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg (E/C/F/TDF) QD + Placebo to match single-table regimen of elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg (E/C/F/TAF) QD for 96 weeks
Drug: elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate
Elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg (E/C/F/TDF) + placebo to match single tablet regimen of elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg (E/C/F/TAF) administered orally QD
Other Name: Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate)

Detailed Description:

Randomized, Double-Blind, multicenter, active-controlled study to evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Disoproxil Fumarate in achieving HIV-1 RNA < 50 copies/mL at Week 48 as defined by the FDA snapshot analysis in HIV-1 infected subjects.

  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 EVG, FTC, TDF
  • Normal electrocardiogram (ECG)
  • Estimated GFR ≥ 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 EVG, COBI, FTC, TDF, 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

Contacts
Contact: Babi Das Wadhwani 650-522-4237 babi.daswadhwani@gilead.com

  Hide Study Locations
Locations
United States, Alabama
The University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact     205-975-7925        
United States, Arizona
Spectrum Medical Group Recruiting
Phoenix, Arizona, United States, 85012
Contact     602-307-5330 ext 2227        
United States, California
Kaiser Permanente Recruiting
Hayward, California, United States, 94545
Contact     510-784-6499        
Peter J. Ruane, MD, Inc. Recruiting
Los Angeles, California, United States, 90036
Contact     323-954-1072 ext 224        
Anthony Mills MD Inc Recruiting
Los Angeles, California, United States, 90069
Contact     310-550-2271        
Kaiser Permanente Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact     323-783-7404        
Cedars-Sinai Medical Center Not yet recruiting
Los Angeles, California, United States, 90048
Contact     310-423-3755        
Alameda County Medical Center Not yet recruiting
Oakland, California, United States, 94602
Contact     510-691-8014        
East Bay AIDS Center Recruiting
Oakland, California, United States, 94609
Contact     510-869-8490        
Stanford University Not yet recruiting
Palo Alto, California, United States, 94304
Contact     650-723-2804        
Kaiser Permanente - Sacramento Recruiting
Sacramento, California, United States, 95825
Contact     916-973-6808        
La Playa Medical Group and Clinical Research Recruiting
San Diego, California, United States, 92103
Contact     619-260-3456        
Kaiser Permanente Medical Center Recruiting
San Francisco, California, United States, 94118
Contact     415-833-3480        
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center Recruiting
Torrance, California, United States, 90502
Contact     310-222-3848        
United States, Colorado
Apex Research, LLC Recruiting
Denver, Colorado, United States, 80209
Contact     303-996-9007        
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06510
Contact     203-785-3557        
United States, District of Columbia
Whitman Walker Clinic Recruiting
Washington, District of Columbia, United States, 20009
Contact     202-939-7661        
Capital Medical Associates, P.C. Recruiting
Washington, District of Columbia, United States, 20036
Contact     202-822-6311        
Medical Faculty Associates, Inc. Recruiting
Washington, District of Columbia, United States, 20037
Contact     202-741-2437        
Dupont Circle Physicians Group, P.C. Recruiting
Washington, District of Columbia, United States, 20009
Contact     202-745-0201 ext 17        
United States, Florida
Gary Richmond, MD, PA, Inc. Recruiting
Fort Lauderdale, Florida, United States, 33316
Contact     954-524-2250 ext 211        
Midway Immunology & Research Center, LLC Recruiting
Fort Pierce, Florida, United States, 34982
Contact     772-464-9746        
TheraFirst Medical Center Recruiting
Ft. Lauderdale, Florida, United States, 33308
Contact     954-564-4222 ext 207        
The Kinder Medical Group Not yet recruiting
Miami, Florida, United States, 33133
Contact     786-497-4000 ext 232        
AIDS Healthcare Foundation Recruiting
Miami Beach, Florida, United States, 33139
Contact     786-497-4000 ext 232        
Orlando Immunology Center Recruiting
Orlando, Florida, United States, 32803
Contact     407-647-3960        
IDOCF/ValuHealthMD, LLC Recruiting
Orlando, Florida, United States, 32806
Contact     407-246-1946        
Infectious Diseases Associates Recruiting
Pensacola, Florida, United States, 32504
Contact     850-476-3131        
St. Joseph's Comprenhensive Research Inisitute Recruiting
Tampa, Florida, United States, 33614
Contact     813-870-4760        
The University of South Florida Recruiting
Tampa, Florida, United States, 33602
Contact     813-307-8015 ext 6460        
Infectious Disease Research Institute Inc. Recruiting
Tampa, Florida, United States, 33614
Contact     813-875-4374 ext 2        
AIDS Research and Treatment Center of the Treasure Coast Recruiting
Vero Beach, Florida, United States, 32960
Contact     772-978-9556        
United States, Georgia
Atlanta ID Group, PC Recruiting
Atlanta, Georgia, United States, 30309
Contact     404-351-8873        
Emory University Recruiting
Atlanta, Georgia, United States, 30308
Contact     404-686-5198        
AIDS Research Consortium of Atlanta Recruiting
Atlanta, Georgia, United States, 30308
Contact     404-876-2317 ext 357        
Infectious Disease Specialist of Atlanta Recruiting
Decatur, Georgia, United States, 30033
Contact     404-297-9755 ext 217        
Mercer University School of Medicine Recruiting
Macon, Georgia, United States, 31201
Contact     478-301-5852        
United States, Hawaii
University of Hawaii - Hawaii Center for AIDS Recruiting
Honolulu, Hawaii, United States, 96816
Contact     808-285-6453        
United States, Illinois
Howard Brown Health Center Recruiting
Chicago, Illinois, United States, 60613
Contact     773-388-8792        
Ruth M. Rothstein CORE Center Recruiting
Chicago, Illinois, United States, 60612
Contact     312-572-4578        
Carolinas Medical Center--Myers Park Infectious Disease Clinic Recruiting
Chicago, Illinois, United States, 60612
Contact     704-446-1642        
Northwestern University Not yet recruiting
Chicago, Illinois, United States, 60611
Contact     312-695-5053        
United States, Maryland
Johns Hopkins University Not yet recruiting
Lutherville, Maryland, United States, 21093
Contact     410-616-2826        
United States, Massachusetts
Boston University Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02118
Contact     617-414-7082        
Community Research Initative Recruiting
Boston, Massachusetts, United States, 02111
Contact     617-502-1725        
Brigham & Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact     617-732-5635        
The Research Institute Recruiting
Springfield, Massachusetts, United States, 01105
Contact     413-747-5566        
United States, Michigan
Be Well Medical Center Recruiting
Berkley, Michigan, United States, 48072
Contact     248-544-9300        
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact     404-351-8873        
United States, Minnesota
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Contact     612-347-8754        
United States, Missouri
Central West Clinical Research, Inc. Recruiting
St Louis, Missouri, United States, 63108
Contact     314-652-0100 ext 32        
Southampton Healthcare, Inc. Recruiting
St Louis, Missouri, United States, 63139
Contact     314-647-2200        
Saint Louis University Recruiting
St. Louis, Missouri, United States, 63110
Contact     314-977-9664        
United States, New Jersey
ID Care Recruiting
Hillsborough, New Jersey, United States, 08844
Contact     908-281-5736        
Saint Michael's Medical Center Recruiting
Newark, New Jersey, United States, 07102
Contact     973-877-2735        
South Jersey Infectious Disease Recruiting
Somers Point, New Jersey, United States, 08244
Contact     609-927-6662 ext 5        
United States, New Mexico
Southwest C.A.R.E. Center Recruiting
Santa Fe, New Mexico, United States, 87505
Contact     505-216-1545        
United States, New York
Upstate Infectious Diseases Associates Recruiting
Albany, New York, United States, 12208
Contact     518-435-0662 ext 2        
Albany Medical College Recruiting
Albany, New York, United States, 12208
Contact     518-262-6330        
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact     718-920-6528        
New York Hospital Queens Not yet recruiting
Flushing, New York, United States, 11355
Contact     718-670-2066        
North Shore University Hospital - Division of Infectious Diseases Recruiting
Manhasset, New York, United States, 11030
Contact     516-562-3361        
Greiger Clinic Recruiting
Mount Vernon, New York, United States, 10550
Contact     914-664-8000 ext 1162        
Chelsea Village Medical Recruiting
New York, New York, United States, 10011
Contact     212-929-2629        
Jacobi Medical Center Recruiting
South Bronx, New York, United States, 10461
Contact     718-918-3662        
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact     919-663-3232        
Infectious Disease Consultants, PA Recruiting
Charlotte, North Carolina, United States, 28209
Contact     704-331-9266        
Duke University Recruiting
Durham, North Carolina, United States, 22710
Contact     919-668-3759        
East Carolina University, The Brody School of Medicine Not yet recruiting
Greenville, North Carolina, United States, 27834
Contact     252-744-1913        
Rosedale Infectious Diseases Recruiting
Huntersville, North Carolina, United States, 28078
Contact     704-331-9669        
Wake Forest University Health Sciences Not yet recruiting
Winston-Salem, North Carolina, United States, 27157
Contact     336-716-4267        
United States, Ohio
Summa Health Care Center Not yet recruiting
Akron, Ohio, United States, 44304
Contact     330-375-3519        
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact     215-955-9725        
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact     215-349-8091        
United States, Rhode Island
The Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact     401-793-4971        
United States, South Carolina
Medical University of South Carolina Not yet recruiting
Charleston, South Carolina, United States, 29425
Contact     843-792-5491        
University of South Carolina School of Medicine Recruiting
Columbia, South Carolina, United States, 29203
Contact     803-434-8262        
United States, Texas
Central Texas Clinical Research Recruiting
Austin, Texas, United States, 78705
Contact     512-480-9660        
Trinity Health and Wellness Center/AIDS Arms, Inc. Recruiting
Dallas, Texas, United States, 75208
Contact     972-807-7370        
North Texas Infectious Diseases Consultants Recruiting
Dallas, Texas, United States, 75246
Contact     214-276-5646        
Tarrant County Infectious Disease Associates Recruiting
Fort Worth, Texas, United States, 76104
Contact     817-348-0042        
Gordon E. Crofoot, MD, PA Recruiting
Houston, Texas, United States, 77098
Contact     713-526-0005        
Therapeutic Concepts, PA Recruiting
Houston, Texas, United States, 77004
Contact     713-526-9821 ext 221        
Research Access Network Recruiting
Houston, Texas, United States, 77098
Contact     713-526-7732        
DCOL Center for Clinical Research Recruiting
Longview, Texas, United States, 75605
Contact     903-238-8854        
United States, Virginia
Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID) Recruiting
Annandale, Virginia, United States, 22003
Contact     703-560-4821        
United States, Washington
Peter Shalit, MD Recruiting
Seattle, Washington, United States, 98104
Contact     206-624-1441        
Rockwood Pulmonary and Critical Care Not yet recruiting
Spokane, Washington, United States, 99204
Contact     509-623-1456        
United States, Wisconsin
Medical College of Wisconsin Not yet recruiting
Milwaukee, Wisconsin, United States, 53226
Contact     414-805-0708        
Australia, New South Wales
Holdsworth House Medical Practice Not yet recruiting
Darlinghurst, New South Wales, Australia, 2010
Contact     +61 2 9331 7228        
St Vincent's Hospital Sydney Not yet recruiting
Darlinghurst, New South Wales, Australia, 2010
Contact     +61 8 3824 2435        
East Sydney Doctors Not yet recruiting
Sydney, New South Wales, Australia, 2010 NSW
Contact     +61 2 9332 2531        
Albion Street Centre Not yet recruiting
Sydney, New South Wales, Australia, 2010
Contact     +61 2 9332 9657        
Australia, Victoria
Melbourne Sexual Health Clinic Not yet recruiting
Carlton, Victoria, Australia, 3053
Contact     +61 3 9341 6262        
Austria
Innsbruck Medical University, Dept of Dermatology and Venereology Not yet recruiting
Innsbruck, Austria, A6020
Contact     +43 51 250 481072        
DIAID, Department of Dermatology, Medical University Vienna Not yet recruiting
Vienna, Austria, 1090
Contact     +43 140 400 4232        
Otto-Wagner-Spital, Sozialmedizinisches Zentrum Baumgartner Hoehe Not yet recruiting
Wien, Austria, 1140
Contact     +431 91060 42002        
Belgium
CHU Saint-Pierre University Hospital Not yet recruiting
Brussels, Belgium, 1000
Contact     +32 2 535 41 31        
Maladies Infectieuses et Tropicales Not yet recruiting
Brussels, Belgium, 1200
Contact     +32 27 64 2155        
University Hospitals Leuven Not yet recruiting
Leuven, Belgium, 3000
Contact     +32 163 44275        
Brazil
UPCAids-UNICAMP Not yet recruiting
Campinas, Brazil, 13083 888
Contact     +55(19) 3521 7745        
Universidade Federal do Rio de Janeiro Not yet recruiting
Campinas, Brazil, 13083 888
Contact     +55-21-22739073        
Instituto de Pesquisa Clínica Evandro Chagas - Fundaçã Not yet recruiting
Rio de Janeiro, Brazil, 21046-900
Contact     +55 21 3865-9127        
Faculdade de Medicina do ABC Not yet recruiting
Santo Andre, Brazil, 00960-650
Contact     +5511 49946900        
Hospital Guilherme Alvaro Not yet recruiting
Santos, Brazil, 11045-904
Contact     +55 13 3202 1392        
Instituto de Infectologia Emillo Ribas Not yet recruiting
Sao Paulo, Brazil, 01246-900
Contact     +5511983957007        
Faculdade de Medicina da Universidade de Sao Paulo Not yet recruiting
Sao Paulo, Brazil, 04038-034
Contact     +55 11 2661 7845        
Centro de Referência e Treinamento DST/AIDS Not yet recruiting
São Paulo, Brazil, 04121-000
Contact     +55 11 5087 9903        
Canada, British Columbia
Spectrum Health Not yet recruiting
Vancouver, British Columbia, Canada, V6Z 2T1
Contact     604-685-3747        
Canada, Manitoba
Health Sciences Centre Winnipeg Recruiting
Winnipeg, Manitoba, Canada, R3A 1R9
Contact     (204) 787-3633        
Canada, Ontario
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact     613-737-8209        
University Health Network/Toronto General Hospital Not yet recruiting
Toronto, Ontario, Canada, M5G 2N2
Contact     416-340-4800 ext 8170        
Maple Leaf Research Recruiting
Toronto, Ontario, Canada, M5G 1K2
Contact     (416) 465-7936        
Canada, Quebec
Clinique OPUS Recruiting
Montreal, Quebec, Canada, H3A 1T1
Contact     (514) 935-1197        
Clinique Medicale Du Quartier Latin Not yet recruiting
Montreal, Quebec, Canada, H2L 5B1
Contact     (514) 285-1497 ext 225        
Clinique medicale l'Actuel Recruiting
Montreal, Quebec, Canada, H2L 5B1
Contact     514-524-3642 ext 239        
Canada
Sunnybrook Health Science Center Recruiting
Toronto, Canada, M4N 3M5
Contact     (416) 480-6044        
Dominican Republic
Instituto Dominicano de Estudio Virologicos - IDEV Not yet recruiting
Santo Domingo, Dominican Republic, 10103
Contact     (809) 535-2220        
France
CHU Bicetre Not yet recruiting
Le Kremlin-Bicêtre, France, 94275
Contact     +33 1 45 21 79 32        
Hôpital de la Croix Rousse Not yet recruiting
Lyon Cedex 4, France, 69317
Contact     +33 4 26 73 27 31        
University Hospital of Montpellier (CHU-Gui de Chauliac) Not yet recruiting
Montpelier Cedex 5, France, 34295
Contact     +33 4 67 33 77 04        
Centre Hospitalier Universitaire de Nice Not yet recruiting
Nice, France, 06202
Contact     +33 49 20 39022        
Hôpital Bichat Claude Bernard Not yet recruiting
Paris, France, 75018
Contact     +33 1 40 25 70 57        
Hopital Saint Louis Not yet recruiting
Paris Cedex 10, France, 75010
Contact     +33 142499067        
Hopital Saint Antoine Not yet recruiting
Paris Cedex 12, France, 75571
Contact     +33 1 49 28 24 86        
Hopital Pitie-Salpetriere Not yet recruiting
Paris Cedex 13, France, 75651
Contact     +33 1 42 16 0142        
Hopital Tenon Not yet recruiting
Paris Cedex 20, France, 75970
Contact     +33 1 56 01 74 12        
Ch Tourcoing Not yet recruiting
Toulon, France, 83056
Contact     +33 (0)320 694617        
Germany
Epimed GmbH Not yet recruiting
Berlin, Germany, 12157
Contact     +49 30 130 202834        
University of Bonn Not yet recruiting
Bonn, Germany, 53127
Contact     +49-228 287 19556        
Center for HIV and Hepatogastroenterology Not yet recruiting
Duesseldorf, Germany, 40237
Contact     +49 211 23955242        
Universitätsklinikum Essen Not yet recruiting
Essen, Germany, 45122
Contact     +49 201 7233696        
Infektio Research GmbH & CoKG Not yet recruiting
Frankfurt, Germany, 60311
Contact     +49 69 713 78 813        
Universitätsklinikum Hamburg-Eppendorf, Ambulanzzentrum des UKE GmbH, Infektiologie Not yet recruiting
Hamburg, Germany, 20246
Contact     +49 407 41052682        
ICH Study Center Hamburg Not yet recruiting
Hamburg, Germany, 20146
Contact     +49-40-284 07 370        
Medizinische Hochschule Hannover Not yet recruiting
Hannover, Germany, 30625
Contact     +49 511 532 5155        
University of Cologne, Department of Internal Medicine Not yet recruiting
Koln, Germany, 50937
Contact     +49 221 478 5860        
MUC Research GmbH Not yet recruiting
München, Germany, 80335
Contact     +49 89 599 8933        
Italy
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi Not yet recruiting
Bologna, Italy, 40138
Contact     +39 05 134 1449        
Divisione Clinicizzata di Malattie Infettive Universita degli Studi Not yet recruiting
Milano, Italy, 20157
Contact     +39 02 390 42451        
Ospedale San Raffaele Not yet recruiting
Milano, Italy, 20127
Contact     +39 02 264 37934        
Azienda Ospedaliera - Polo Universitario Ospedale San Paolo Not yet recruiting
Milano, Italy, 20142
Contact     +39-02 818 43046        
University of Modena and Reggio Emilia Not yet recruiting
Modena, Italy, 41100
Contact     +39 059 422 2466        
Foundation San Matteo Hospital Not yet recruiting
Pavia, Italy, 27100
Contact     +39-0382 502959        
Japan
National Center for Global Health and Medicine AIDS Clinical Center Recruiting
Shinjuku-ku, Tokyo, Japan, 162-8655
Contact     81-3-3202-7181        
Mexico
Hospital Civil de Guadalajara Not yet recruiting
Guadalajara, Mexico, 44280
Contact     +523336147586        
Netherlands
Onze Lieve Vrouwe Gasthuis Not yet recruiting
Amsterdam, Netherlands, 1091 AC
Contact     +31 20 599 3500        
Erasmus MC Not yet recruiting
Rotterdam, Netherlands, 3000CA
Contact     +31 107 033510        
Portugal
Servico de Doencas Infecciosas Not yet recruiting
Coimbra, Portugal, 3000-075
Contact     +35 123 940 0402        
Centro Hospitalar Lisboa Central - Hospital Capuchos Not yet recruiting
Lisboa, Portugal, 1160-050
Contact     +35 191 228 8422        
Hospital de Santa Maria Not yet recruiting
Lisbon, Portugal, 1649-035
Contact     +351 217 805 274        
Centro Hospitalar do Porto - Hospital Joaquim Urbano Not yet recruiting
Porto, Portugal, 4350-086
Contact     +35 12 258 99550        
Puerto Rico
HOPE Clinical Research Recruiting
San Juan, Puerto Rico, 00909
Contact     (787) 268-7078        
University of Puerto Rico School of Medicine Not yet recruiting
San Juan, Puerto Rico, 00935
Contact     787-767-9193        
Spain
Hospital Germans Trias i Pujol Not yet recruiting
Badalona, Spain, 08916
Contact     +34 49 349 78849        
Hospital Clinic i Provincial Not yet recruiting
Barcelona, Spain, 08036
Contact     +34 93 227 5574        
Hospital Universitario La Paz Not yet recruiting
Madrid, Spain, 28046
Contact     +34 91 727 7099        
Hospital Universitario 12 de Octubre Not yet recruiting
Madrid, Spain, 28041
Contact     +34 91 779 2220        
Complejo Hospitalario Universitario de Santiago (CHUS) Not yet recruiting
Santiago de Compostela, Spain, 15706
Contact     +34 98 195 1276        
Sweden
Venhälsan, Södersjukhuset Not yet recruiting
Stockholm, Sweden, 11883
Contact     +46 86 162 696        
Karolinska Institutet Not yet recruiting
Stockholm, Sweden, 14186
Contact     +46 85 858 2269        
Switzerland
Universitätsspital Bern Not yet recruiting
Berne, Switzerland, 3010
Contact     +41 31 632 41 45        
Centre Hospitalier Universitaire Vaudois Not yet recruiting
Lausanne, Switzerland, 1011
Contact     +41 21 314 1022        
University Hospital, Zurich Not yet recruiting
Zurich, Switzerland, CH-8091
Contact     +41 44 255 3402        
Thailand
The HIV Netherland Australia Thailand, Thai Red Cross AIDS Research Center (The HIV-NAT) Not yet recruiting
Bangkok, Thailand, 10330
Contact     +66 2-652-3040 ext 167        
Siriraj Hospital Not yet recruiting
Bangkok, Thailand, 10700
Contact     +6622012107        
Ramathibodi Hospital, Mahidol University Not yet recruiting
Bangkok, Thailand, 10400
Contact     +662-419-7388        
Khon Kaen University Not yet recruiting
Khon Kaen, Thailand, 40002
Contact     +66-43-363169        
United Kingdom
Whittall Street Clinic Not yet recruiting
Birmingham, United Kingdom, B4 6DH
Contact     +44 (0)121 237 2707        
Brighton and Sussex University Hospitals NHS Trust Not yet recruiting
Brighton, United Kingdom, BN2 3EW
Contact     +44 (01273 523079        
Brownlee Centre, Gartnavel General Hospital Not yet recruiting
Glasgow, United Kingdom, G12OYN
Contact     +44 (0)141 211 3261        
Chelsea & Westminster Hospital Not yet recruiting
London, United Kingdom, SW10 9TH
Contact     +020 8746 5620        
King's College Hospital Not yet recruiting
London, United Kingdom, SE5 9RJ
Contact     +44 207 848 5779        
The Royal Free Hampstead NHS Trust Not yet recruiting
London, United Kingdom, NW3 2QG
Contact     +44 (0)207 941 1836        
Barts & The London NHS Trust Not yet recruiting
London, United Kingdom, E1 1BB
Contact     +44 207 377 7457        
Mortimer Market Centre Not yet recruiting
London, United Kingdom, WC1E 6JB
Contact     +44 (0) 203 317 5241        
North Manchester General Hospital Not yet recruiting
Manchester, United Kingdom, M8 5RB
Contact     +44 (0)161 720 2733        
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: May 7, 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 May 16, 2013