HIV Infections Clinical Trial
Official title:
A Phase 3b Randomized, Open Label Study to Evaluate Switching From Regimens Consisting of a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) Plus Emtricitabine (FTC) and Tenofovir DF (TDF) to the Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) in Virologically Suppressed, HIV 1 Infected Patients
Verified date | December 2015 |
Source | Gilead Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This study will evaluate the noninferiority of Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative to regimens consisting of a nonnucleoside reverse transcriptase inhibitor (NNRTI) plus Truvada® (FTC/TDF) in maintaining HIV-1 RNA < 50 copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of the two regimens through 96 weeks of treatment.
Status | Completed |
Enrollment | 439 |
Est. completion date | December 2014 |
Est. primary completion date | November 2013 |
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 - Be stable on the current formulation(s) of an antiretroviral regimen consisting of an NNRTI plus FTC/TDF for = 6 consecutive months preceding the screening visit. This includes those who began a regimen with individual drug components and subsequently simplified to include a fixed-dose combination formulation of the same drugs. - Be on the first or second antiretroviral regimen with documented undetectable plasma HIV 1 RNA levels for = 6 months preceding the screening visit - No previous use of any approved or experimental integrase strand transfer inhibitor (INSTI) for any length of time - Documented historical genotype prior to starting initial antiretroviral therapy showing no known resistance to TDF or FTC - HIV RNA < 50 copies/mL at screening - Normal ECG - Hepatic transaminases = 5 × the upper limit of the normal range (ULN) - Total bilirubin = 1.5 mg/dL - Adequate hematologic function - Serum amylase = 5 × ULN - Estimated glomerular filtration rate = 70 mL/min - Females of childbearing potential must agree to utilize protocol recommended contraception methods or be nonheterosexually active, practice sexual abstinence from screening throughout the duration of the study period and for 12 weeks for participants on EFV/FTC/TDF or efavirenz or 30 days for the rest of participants following the last dose of study drug - Female participants 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 - Male participants must agree to utilize protocol-recommended methods of contraception during heterosexual intercourse or be nonheterosexually active, and practice sexual abstinence from the screening visit. - Age = 18 years Exclusion Criteria: - New AIDS-defining condition diagnosed within the 30 days prior to screening - Females who are breastfeeding - Positive serum pregnancy test (female of childbearing potential) - Receiving drug treatment for hepatitis C, or those who are anticipated to receive treatment for hepatitis C during the course of the study - Experiencing decompensated cirrhosis - Have an implanted defibrillator or pacemaker - Current alcohol or substance abuse that would interfere with 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, noninvasive cutaneous squamous carcinoma. Persons with cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of baseline and must not be anticipated to require systemic therapy during the study. - Active, serious infections requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline - Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study - Receiving ongoing therapy with any of the medications, including drugs not to be used with elvitegravir, cobicistat, FTC, or TDF; or those with any known allergies to the excipients of E/C/F/TDF tablets, or FTC/TDF tablets - No anticipated need to initiate drugs during the study that are contraindicated - Receiving other investigational drugs - Participation in any other clinical trial - Any other clinical condition or prior therapy that would make the participant unsuitable for the study or unable to comply with the dosing requirements |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Holdsworth House Medical Practice | Darlinghurst | |
Australia | Prahran Market Clinic | South Yarra | |
Australia | East Sydney Doctors | Sydney | |
Austria | Medical University of Vienna | Wien | |
Austria | Otto Wagner Spital | Wien | |
Belgium | SEAMEO Regional Centre for Tropical Medicine | Antwerpen | |
Belgium | Hôpitaux IRIS Sud | Bruxelles | |
Belgium | University Hospital of Leuven | Leuven | |
Canada | Clinique Medicale Du Quartier Latin | Montreal | Quebec |
Canada | Maple Leaf Medical Clinic | Toronto | Ontario |
Canada | Sunnybrook Health Sciences Center | Toronto | Ontario |
France | CHU de Besancon - Hopital Saint-Jacques | Besancon | |
France | Groupe Hospitalier Pellegrin | Bordeaux | |
France | Hopital Bichat Claude Bernard | Paris | |
France | Hopital Saint Antoine | Paris | |
France | Hopital Saint Louis | Paris | |
Germany | EPIMED GmbH | Berlin | |
Germany | MIB Dienstleistung GmbH | Berlin | |
Germany | Medizinische Universitätsklinik | Bonn | |
Germany | Infektiologikum | Frankfurt | |
Germany | Universitatsklinikum Freiburg | Freiburg | |
Germany | ICH Study Center | Hamburg | |
Germany | MUC Research GmbH | München | |
Italy | Azienda Ospedaliera Ospedale di Circolo Busto Arsizio | Busto Arsizio/Varese | |
Italy | Fondazione Centro San Raffaele del Monte Tabor | Milano | |
Italy | Ospedale Luigi Sacco | Milano | |
Italy | Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS | Roma | |
Italy | Policlinico Universitario Agostino Gemelli | Rome | |
Portugal | Hospital de Santa Maria - CHLN EPE | Lisboa | |
Puerto Rico | Clinical Research Puerto Rico Inc | San Juan | |
Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | Cataluña |
Spain | Hospital del Mar | Barcelona | |
Spain | Hospital General Universitario Gregorio Maranon | Madrid | |
Spain | Hospital Clinico Universitario de Santiago | Santiago de Compostela | Galicia |
Spain | Hospital La Fe de Valencia | Valencia | |
United Kingdom | Brighton and Sussex University Hospitals NHS Trust | Brighton | |
United Kingdom | Western General Hospital | Edinburgh | |
United Kingdom | Chelsea & Westminster Hospital | London | |
United Kingdom | Homerton University Hospital | London | |
United Kingdom | South London Healthcare NHS Trust | London | |
United Kingdom | St. Thomas' Hospital | London | |
United States | Clinical Alliance for Research & Education - Infectious Disease | Annandale | Virginia |
United States | Atlanta ID Group, PC | Atlanta | Georgia |
United States | Be Well Medical Center | Berkley | Michigan |
United States | AHF Research Center | Beverly Hills | California |
United States | Pacific Oak Medical Group | Beverly Hills | California |
United States | ID Consultants, P.A. | Charlotte | North Carolina |
United States | Southwest Infectious Disease Clinical Researach Inc | Dallas | Texas |
United States | Infectious Disease Specialists of Atlanta | Decatur | Georgia |
United States | Gary Richmond MD, PA, Inc | Fort Lauderdale | Florida |
United States | Midway Immunology and Research | Fort Pierce | Florida |
United States | Tarrant County Infectious Disease Associates | Fort Worth | Texas |
United States | Kaiser Permanente | Hayward | California |
United States | ID Care | Hillsborough | New Jersey |
United States | Gordon E. Crofoot MD, PA | Houston | Texas |
United States | Therapeutic Concepts PA | Houston | Texas |
United States | The Kansas City Free Health Clinic | Kansas City | Missouri |
United States | Anthony Mills MD Inc | Los Angeles | California |
United States | OASIS Clinic | Los Angeles | California |
United States | Peter J. Ruane, MD, Inc. | Los Angeles | California |
United States | The Kinder Medical Group | Miami | Florida |
United States | HIV Program Hennepin County Medical Center | Minneapolis | Minnesota |
United States | Greiger Clinic | Mt. Vernon | New York |
United States | Aaron Diamond AIDS Research Center | New York | New York |
United States | Saint Michael's Medical Center | Newark | New Jersey |
United States | Alameda County Medical Center | Oakland | California |
United States | Orlando Immunology Center | Orlando | Florida |
United States | ValuHealth MD, LLC | Orlando | Florida |
United States | Infectious Diseases Associates of Northwest Florida | Pensacola | Florida |
United States | Philadelphia FIGHT | Philadelphia | Pennsylvania |
United States | Spectrum Medical Group | Phoenix | Arizona |
United States | Kaiser Permanente Medical Group | Sacramento | California |
United States | Health Positive | Safety Harbor | Florida |
United States | La Playa Medical Group and Clinical Research | San Diego | California |
United States | Kaiser Permanente | San Francisco | California |
United States | Metropolis Medical | San Francisco | California |
United States | South Jersey Infectious Disease | Somers Point | New Jersey |
United States | Capital Medical Associates, P.C. | Washington | District of Columbia |
United States | Dupont Circle Physicians Group, P.C. | 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, Canada, France, Germany, Italy, Portugal, Puerto Rico, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 | The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time. | Week 48 | No |
Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 | The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time. | Week 96 | No |
Secondary | Change From Baseline in CD4+ Cell Count at Week 48 | Baseline; Week 48 | No | |
Secondary | Change From Baseline in CD4+ Cell Count at Week 96 | Baseline; Week 96 | No |
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