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
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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 |
- 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
- 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 |
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| Contact: Babi Das Wadhwani | 650-522-4237 | babi.daswadhwani@gilead.com |
Hide Study 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 | |
| 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