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Generated: December 12, 2018

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CLINICAL TRIALS PROFILE FOR GENVOYA

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Clinical Trials for Genvoya

Trial ID Title Status Sponsor Phase Summary
NCT00537966 Characterization of Acute and Recent HIV-1 Infections in Zurich: a Long-term Observational Study Recruiting University of Zurich N/A 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 This study will 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 Active, not recruiting Gilead Sciences Phase 3 This study will 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 positive, antiretroviral treatment-naive adults.
NCT01797445 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 Active, not recruiting Gilead Sciences Phase 3 This study will evaluate the efficacy and safety 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) 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 Active, not recruiting Gilead Sciences Phase 3 This open-label, multicenter, multi-cohort study is to assess the safety, tolerability, and efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) fixed-dose combination (FDC) tablet in treatment-naive and treatment-experienced HIV-positive, adult participants with mild to moderate renal impairment. The primary objective of this study is to evaluate the effect of E/C/F/TAF on renal parameters at Week 24. The proportion of subjects achieving virologic response of HIV-1 RNA < 50 copies/mL will also be assessed. At sites able to conduct the appropriate testing, approximately 30 participants will be enrolled into an intensive pharmacokinetic/pharmacodynamic (PK/PD) substudy to evaluate the PK/PD parameters of the individual components of E/C/F/TAF as well as tenofovir diphosphate (TFV-DP).
NCT02071082 Efficacy and Safety of E/C/F/TAF (Genvoya®) in HIV-1/Hepatitis B Co-infected Adults Active, not recruiting Gilead Sciences Phase 3 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
NCT02251236 Elvitegravir (EVG) Cerebrospinal Fluid (CSF) Pharmacokinetics in HIV-Infected Individuals Active, not recruiting Gilead Sciences N/A The project will have two tracks, one for participants who are currently taking elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or E/C/F/tenofovir alafenamide (E/C/F/TDF or E/C/F/TAF) single-tablet regimen* (STR) (Track A) and one for participants who will begin therapy with E/C/F/TDF or E/C/F/TAF STR during the study (Track B). Participants will take E/C/F/TDF and/or E/C/F/tenofovir alafenamide fumarate (E/C/F/TAF) STR** (if available) for 24 weeks. *Co-formulation of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 300 mg of tenofovir disoproxil fumarate. **Co-formulation of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamide fumarate.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Genvoya

Condition Name

Condition Name for Genvoya
Intervention Trials
HIV Infections 9
HIV 5
HIV/AIDS 3
Hepatitis C, Chronic 2
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Condition MeSH

Condition MeSH for Genvoya
Intervention Trials
HIV Infections 11
Immunologic Deficiency Syndromes 3
Acquired Immunodeficiency Syndrome 3
Hepatitis C 2
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Clinical Trial Locations for Genvoya

Trials by Country

Trials by Country for Genvoya
Location Trials
United States 110
Canada 16
Puerto Rico 4
Australia 4
Belgium 3
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Trials by US State

Trials by US State for Genvoya
Location Trials
California 8
Georgia 7
Missouri 5
Michigan 5
Florida 5
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Clinical Trial Progress for Genvoya

Clinical Trial Phase

Clinical Trial Phase for Genvoya
Clinical Trial Phase Trials
Phase 4 3
Phase 3 6
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Genvoya
Clinical Trial Phase Trials
Recruiting 7
Active, not recruiting 5
Not yet recruiting 5
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Clinical Trial Sponsors for Genvoya

Sponsor Name

Sponsor Name for Genvoya
Sponsor Trials
Gilead Sciences 12
Emory University 2
Centers for Disease Control and Prevention 2
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Sponsor Type

Sponsor Type for Genvoya
Sponsor Trials
Other 19
Industry 15
U.S. Fed 2
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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
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QuintilesIMS
Argus Health
Express Scripts
Johnson and Johnson
Mallinckrodt
Chubb

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