HIV Infections Clinical Trial
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
This study is designed to evaluate the safety and efficacy of a regimen containing Cobicistat (COBI)-boosted atazanavir (ATV/co) plus emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus ritonavir (RTV)-boosted atazanavir (ATV/r) plus FTC/TDF in HIV-1-infected, antiretroviral treatment-naive adults. Development of COBI as a "pharmacoenhancer" could provide a beneficial alternative to RTV for use in combination with protease inhibitors.
Status | Completed |
Enrollment | 698 |
Est. completion date | April 2015 |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures - Plasma HIV-1 RNA levels = 5,000 copies/mL at screening - No prior use of any approved or investigational antiretroviral drug for any length of time - Screening genotype report must show sensitivity to FTC, TDF and ATV - Normal ECG - Adequate renal function (eGFR calculated using the Cockcroft-Gault equation = 70 mL/min) - Hepatic transaminases (AST and ALT) = 5 x upper limit of normal (ULN) - Total bilirubin = 1.5 mg/dL, or normal direct bilirubin - Adequate hematologic function - Serum amylase = 5 x ULN - Males and females of childbearing potential must agree to utilize highly effective contraception methods from screening throughout the duration of study treatment and for 30 day s following the last dose of study drug. - Age = 18 years - Life expectancy = 1 year Exclusion Criteria: - A new AIDS defining condition diagnosed within the 30 days prior to screening - Receiving drug treatment for Hepatitis C, or anticipated to receive treatment for Hepatitis C - Subjects experiencing decompensated cirrhosis - Females who are breastfeeding - Positive serum pregnancy test (female of childbearing potential) - Have an implanted defibrillator or pacemaker - Have an ECG PR interval = 220 msec - Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance. - A history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. - Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline. - Medications contraindicated for use with COBI, emtricitabine (FTC), tenofovir disoproxil fumarate (TDF), atazanavir (ATV), ritonavir (RTV) or subjects with any known allergies to the excipients of COBI tablets, Truvada tablets, atazanavir capsules or ritonavir tablets. - Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial. - Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Melbourne Sexual Health Centre | Carlton | Victoria |
Australia | St Vincent's Hospital, Sydney | Darlinghurst | New South Wales |
Australia | Taylor Square Private Clinic | Darlinghurst | New South Wales |
Australia | Alfred Hospital | Melbourne | Victoria |
Australia | Northside Clinic | Melbourne | Victoria |
Australia | Albion Street Centre | Sydney | New South Wales |
Australia | Holdsworth House Medical practice | Sydney | New South Wales |
Austria | LKH Graz West | Graz | |
Austria | Allgemeines Krankenhaus | Vienna | |
Austria | Interne Lungenabteilung, SMZ Baumgartner Hoehe - Otto-Wagner-Spital | Vienna | |
Belgium | CHU Saint-Pierre University Hospital | Brussels | |
Belgium | Hôpital Universitaire Erasme - ULB | Brussels | |
Belgium | University of Ghent | Ghent | |
Brazil | Universidade Estadual de Campinas | Campinas | |
Brazil | Instituto De Pesquisa Clinica Evandro Chagas | Rio de Janeiro | RJ |
Brazil | URDIP Faculdade de Medicina do ABC | Santo Andre | Sao Paulo |
Brazil | Brasilmed Assistencia Medica E Pesquisas | São Paulo | |
Brazil | Crt-Dst/Aids | São Paulo | |
Brazil | Instituto De Infectologia Emilo Ribas | São Paulo | |
Canada | Clinique Medicale du Quartier Latin | Montreal | Quebec |
Canada | Clinique medicale l'Actuel | Montreal | Quebec |
Canada | Project LORI | Montreal | |
Canada | Immunodeficiency Service, McGill University Health Centre (MUHC) - Montreal Chest Institute | Montréal | Quebec |
Canada | Canadian Immunodeficiency Research Collaborative (CIRC) Inc. | Toronto | Ontario |
Canada | University Health Network, Toronto General Hospital | Toronto | Ontario |
Canada | Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg | Winnipeg | Manitoba |
Denmark | Rigshospitalet, Infektionsklinik 5112 | Copenhagen | |
Dominican Republic | Instituto Dominicano de Estudios Virologicos - IDEV | Santo Domingo | |
France | Service des Maladies Infectieuses, CHU de Caen | Caen | |
France | Hôpital de la Croix Rousse - Maladies Infectieuses et Tropicales | Lyon | |
France | Hopital Sainte Marguerite Service d'Immuno-Hématologie Clinique -CISIH | Marseille | |
France | CHU de Nantes Hopital de l'Hotel Dieu | Nantes | |
France | Bichat Hospital | Paris | |
France | Department of Infectious Diseases, Saint-Louis hospital | Paris | |
France | Hopital Saint Antoine, Service De Maladies Infectieuses | Paris | |
France | Maladies Infectieuses Dpt | Paris | |
France | Tenon Hospital, UPMC | Paris | |
France | Centre François Magendie, Hôpital du Haut Lévêque | Pessac | |
France | Centre Hospitalier de Tourcoing | Tourcoing | |
Germany | EPIMED GmbH | Berlin | |
Germany | Medizinische Universitätsklinik | Bonn | |
Germany | Infektio Research GmbH / Infektiologikum Frankfurt | Frankfurt am Main | |
Germany | ICH Study Center Hamburg | Hamburg | |
Germany | University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit | Hamburg | |
Germany | University of Cologne, Department of Internal Medicine | Koln | |
Italy | Fondazione Centro San Raffaele del Monte Tabor | Milan | |
Italy | Azienda Ospedaliera Luigi Sacco 1° Divisione Malattie Infettive | Milano | |
Italy | Istituto Nazionale Malattie Infettive Lazzaro Spallanzani | Roma | |
Italy | Dipartimento di Malattie Infettive | Torino | |
Mexico | Unidad de VIH, Hospital Civil de Guadalajara, Fray Antonio Alcalde | Guadalajara | Jalisco |
Netherlands | Onze lieve vrouw gasthuis | Amsterdam | |
Portugal | Hospital de Santa Maria - CHLN | Lisbon | |
Portugal | Serviço de Doenças Infecciosas, Hospital de São João | Porto | |
Puerto Rico | Instituto de Investigacion Clentifica del Sur | Ponce | |
Puerto Rico | Clinical Research Puerto Rico | San Juan | |
Spain | Hospital General Universitario Gregorio Marañon | Madrid | |
Spain | Hospital Virgen del Rocio | Sevilla | |
Switzerland | Universitätsklinik für Infektiologie, Universitätsspital Bern | Bern | |
Switzerland | CHUV | Lausanne | VD |
Switzerland | Division of Infectious Diseases and Hospital Hygiene; University Hospital of Zurich | Zürich | |
Thailand | HIV-NAT, Thai Red Cross AIDS Research Center and Faculty of Medicine Chulalongkorn University | Bangkok | |
Thailand | Ramathibodi Hospital, Mahidol University | Bangkok | |
Thailand | Siriraj Hospital | Bangkok | |
Thailand | Maharaj Nakorn Chiang Mai University, Faculty of Medicine, Department of Medicine | Chiang Mai | |
Thailand | Khon Kaen University | Khon Kaen | |
United Kingdom | Brighton and Sussex University Hospitals NHS Trust | Brighton | East Sussex |
United Kingdom | Barts and the London NHS Trust | London | |
United Kingdom | Courtyard Clinic, St. Georges Hospital | London | |
United Kingdom | Guys and St. Thomas' NHS Trust | London | |
United Kingdom | Homerton University Hospital | London | |
United States | Johns Hopkins University School of Medicine | Baltimore | Maryland |
United States | Be Well Medical Center | Berkley | Michigan |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Community Research Initiative of New England | Boston | Massachusetts |
United States | Montefiore Medical Center - AIDS Center | Bronx | New York |
United States | Carolinas Medical Center-Myers Park | Charlotte | North Carolina |
United States | Howard Brown Health Center | Chicago | Illinois |
United States | University of South Carolina | Columbia | South Carolina |
United States | Southwest Infectious Disease Clinical Research, Inc. | Dallas | Texas |
United States | Infectious Disease Specialists of Atlanta | Decatur | Georgia |
United States | Apex Research, LLC | Denver | Colorado |
United States | Henry Ford Health System | Detroit | Michigan |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Broward Health/Comprehensive Care Center | Fort Lauderdale | Florida |
United States | Therafirst Medical Center | Fort Lauderdale | Florida |
United States | Midway Immunology and Research Center | Fort Pierce | Florida |
United States | Tarrant County Infectious Disease Associates | Fort Worth | Texas |
United States | East Carolina University, The Brody School of Medicine | Greenville | North Carolina |
United States | Garcia's Family Health Group | Harlingen | Texas |
United States | Gordon E. Crofoot MD PA | Houston | Texas |
United States | Research Access Network | Houston | Texas |
United States | Therapeutic Concepts, PA | Houston | Texas |
United States | Rosedale Infectious Diseases | Huntersville | North Carolina |
United States | Health for Life Clinic PLLC | Little Rock | Arkansas |
United States | Living Hope Clinical Foundation | Long Beach | California |
United States | DCOL Center for Clinical Research | Longview | Texas |
United States | Anthony Mills MD Inc | Los Angeles | California |
United States | Kaiser Permanente | Los Angeles | California |
United States | Los Angeles Gay and Lesbian Center DBA Jeffrey Goodman Special Care Clinic | Los Angeles | California |
United States | Oasis Clinic | Los Angeles | California |
United States | Peter J Ruane, MD, Inc | Los Angeles | California |
United States | Mercer University School of Medicine | Macon | Georgia |
United States | North Shore University Hospital | Manhasset | New York |
United States | The Kinder Medical Group | Miami | Florida |
United States | University of Miami School of Medicine | Miami | Florida |
United States | Wohlfeiler, Piperato and Associates, LLC | Miami Beach | Florida |
United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | Hennepin County Medical Center | Minneapolis | Minnesota |
United States | Chelsea Village Medical, PC | New York | New York |
United States | Mt Sinai School of Medicine | New York | New York |
United States | Ricky K. Hsu, MD, PC | New York | New York |
United States | Saint Michaels Medical Center | Newark | New Jersey |
United States | Idocf/ Valuhealthmd, Llc | Orlando | Florida |
United States | Orlando Immunology Center | Orlando | Florida |
United States | Division of Infectious Diseases, Thomas Jefferson University | Philadelphia | Pennsylvania |
United States | Philadelphia FIGHT | Philadelphia | Pennsylvania |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Spectrum Medical Group | Phoenix | Arizona |
United States | Kaiser Permanente Medical Group | Sacramento | California |
United States | University of California, Davis Medical Center | Sacramento | California |
United States | La Playa Medical Group and Clinical Research | San Diego | California |
United States | Kaiser Permanente Medical Center, Clinical Trials Unit | San Francisco | California |
United States | Metropolis Medical | San Francisco | California |
United States | SouthWest CARE Center | Santa Fe | New Mexico |
United States | Peter Shalit, M.D. | Seattle | Washington |
United States | South Jersey Infectious Disease | Somers Point | New Jersey |
United States | CentralWest Clinical Research | St. Louis | Missouri |
United States | Infectious Disease Research Institute Inc. | Tampa | Florida |
United States | St. Joseph's Comprehensive Research Institute | Tampa | Florida |
United States | University of South Florida HIV Clinical Research Unit / Hillsborough County Health Department | Tampa | Florida |
United States | Dupont Circle Physicians Group | Washington | District of Columbia |
United States | George Washington University Medical Faculty Associates | Washington | District of Columbia |
United States | Whitman-Walker Clinic | Washington | District of Columbia |
United States | Wake Forest University Health Sciences | Winston Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Gilead Sciences |
United States, Australia, Austria, Belgium, Brazil, Canada, Denmark, Dominican Republic, France, Germany, Italy, Mexico, Netherlands, Portugal, Puerto Rico, Spain, Switzerland, Thailand, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the FDA snapshot algorithm. | Week 48 | No |
Secondary | Change From Baseline in CD4 Cell Count at Week 48 | The change from baseline in CD4 cell count at Week 48 was analyzed. | Baseline to Week 48 | No |
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