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CLINICAL TRIALS PROFILE FOR GENVOYA

All Clinical Trials for GENVOYA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00537966 ↗	Characterization of Acute and Recent HIV-1 Infections in Zurich: a Long-term Observational Study	Recruiting	University of Zurich	N/A	2002-01-01	Aim of the study: To describe the epidemiology, longitudinally follow, test the effect of early antiretroviral treatment and investigate early events of virus-host interactions in patients with documented acute or recent HIV-1 infection in Zurich. Study design: This is an open label, non-randomized, observational, single center study at the University Hospital Zurich, Division of Infectious Diseases and Hospital Epidemiology. We aim at enrolling approximately 300 patients over a 10 year period. All patients who fulfill the inclusion criteria of a documented acute or recent HIV infection can participate in the study. Patients are offered early combination antiretroviral treatment (cART), if treatment start falls within 90 days after diagnosis of acute HIV-infection. After one year of suppressed HIV-plasma viremia (< 50 copies/ml) patients can chose to stop cART. Patients who have not chosen to undergo early-cART, respectively will stop cART after one year will be followed for a total of 5 years. Viral setpoints reached after treatment interruptions will be compared to historic controls and to the control group not having received cART during acute infection. A battery of virological and immunological assays will be performed on blood samples obtained to better understand early virus-host interactions, which are thought to play a key role in HIV-pathogenesis research. Summary: In summary, this study will provide comprehensive knowledge on early HIV-infection with regard to epidemiology, impact of early-cART on the course of disease and forms the base for a variety of translational research projects addressing early key pathogenesis events between virus and host, relevant for the course of disease, for transmission, for development of vaccines and new treatment strategies. - Trial with medicinal product
NCT01497899 ↗	Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Infected, Antiretroviral Treatment-Naive Adults	Completed	Gilead Sciences	Phase 2	2011-12-28	The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) FDC in HIV-1 infected, antiretroviral treatment-naive adults.
NCT01780506 ↗	Study to Evaluate the Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Positive, Antiretroviral Treatment-Naive Adults	Completed	Gilead Sciences	Phase 3	2012-12-26	The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) FDC in HIV-1 positive, antiretroviral treatment-naive adults.
NCT01818596 ↗	Open-label Safety Study of E/C/F/TAF (Genvoya®) in HIV-1 Positive Patients With Mild to Moderate Renal Impairment	Completed	Gilead Sciences	Phase 3	2013-03-27	The primary objective of this study is to evaluate the effect of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) tablet on renal parameters at Week 24 in treatment-naive and treatment-experienced HIV-positive, adults with mild to moderate renal impairment.
NCT02071082 ↗	Efficacy and Safety of E/C/F/TAF (Genvoya®) in HIV-1/Hepatitis B Co-infected Adults	Completed	Gilead Sciences	Phase 3	2014-02-25	This study will assess the efficacy, safety, and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) in human immunodeficiency virus (HIV)/hepatitis B virus (HBV) coinfected adults. Participants will be enrolled into two cohorts: - Cohort 1: HIV/HBV coinfected adults who are HIV treatment-naive and HBV treatment-naive - Cohort 2: HIV/HBV coinfected adults who are HIV-suppressed

Clinical Trial Conditions for GENVOYA

Condition Name

Condition Name for GENVOYA
Intervention	Trials
HIV Infections	9
HIV	4
HIV/AIDS	4
Hepatitis C, Chronic	2

Condition MeSH

Condition MeSH for GENVOYA
Intervention	Trials
HIV Infections	14
Acquired Immunodeficiency Syndrome	7
Infections	3
Infection	3

Clinical Trial Locations for GENVOYA

Trials by Country

Trials by Country for GENVOYA
Location	Trials
United States	88
Canada	14
Australia	4
Belgium	3
Switzerland	3

Trials by US State

Trials by US State for GENVOYA
Location	Trials
Georgia	7
California	7
Missouri	4
Michigan	4
Florida	4

Clinical Trial Progress for GENVOYA

Clinical Trial Phase

Clinical Trial Phase for GENVOYA
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	5
Phase 2	2

Clinical Trial Status

Clinical Trial Status for GENVOYA
Clinical Trial Phase	Trials
Completed	11
Recruiting	4
Unknown status	2

Clinical Trial Sponsors for GENVOYA

Sponsor Name

Sponsor Name for GENVOYA
Sponsor	Trials
Gilead Sciences	12
Centers for Disease Control and Prevention	3
Emory University	3

Sponsor Type

Sponsor Type for GENVOYA
Sponsor	Trials
Other	23
Industry	15
U.S. Fed	3