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Generated: February 18, 2019

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CLINICAL TRIALS PROFILE FOR TENOFOVIR ALAFENAMIDE FUMARATE

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Clinical Trials for Tenofovir Alafenamide Fumarate

Trial ID Title Status Sponsor Phase Summary
NCT00036634 A Dose Escalation Study of Tenofovir Alafenamide in Treatment-Naive Patients Completed Gilead Sciences Phase 1/Phase 2 This study evaluated two doses of tenofovir alafenamide versus tenofovir disoproxil fumarate (tenofovir DF).
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.
NCT01565850 D/C/F/TAF Versus COBI-boosted DRV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment Naive Adults Completed Gilead Sciences Phase 2 This study is to evaluate the safety and efficacy darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC) tablet versus darunavir (DRV)+cobicistat (COBI)+emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) in HIV-1 infected, antiretroviral treatment-naive adults as determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 24.
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.
NCT01815736 Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants Active, not recruiting Gilead Sciences Phase 3 This study is to evaluate the non-inferiority of switching to a tenofovir alafenamide (TAF)-containing fixed dose combination (FDC) relative to maintaining tenofovir disoproxil fumarate (TDF)-containing combination regimens in virologically suppressed HIV-infected participants as determined by having HIV-1 RNA < 50 copies/mL at Week 48.
NCT01940341 Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Negative Hepatitis B Active, not recruiting Gilead Sciences Phase 3 The primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B virus (HBV) infection.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Tenofovir Alafenamide Fumarate

Condition Name

Condition Name for Tenofovir Alafenamide Fumarate
Intervention Trials
Hiv 8
HIV-1 Infection 7
HIV Infections 7
HBV 5
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Condition MeSH

Condition MeSH for Tenofovir Alafenamide Fumarate
Intervention Trials
Hepatitis B 12
Hepatitis 11
HIV Infections 10
Hepatitis, Chronic 5
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Clinical Trial Locations for Tenofovir Alafenamide Fumarate

Trials by Country

Trials by Country for Tenofovir Alafenamide Fumarate
Location Trials
United States 285
China 51
Canada 40
France 14
Australia 14
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Trials by US State

Trials by US State for Tenofovir Alafenamide Fumarate
Location Trials
California 19
Florida 17
New York 15
Texas 14
Missouri 14
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Clinical Trial Progress for Tenofovir Alafenamide Fumarate

Clinical Trial Phase

Clinical Trial Phase for Tenofovir Alafenamide Fumarate
Clinical Trial Phase Trials
Phase 4 7
Phase 3 21
Phase 2 6
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Clinical Trial Status

Clinical Trial Status for Tenofovir Alafenamide Fumarate
Clinical Trial Phase Trials
Active, not recruiting 15
Recruiting 13
Not yet recruiting 7
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Clinical Trial Sponsors for Tenofovir Alafenamide Fumarate

Sponsor Name

Sponsor Name for Tenofovir Alafenamide Fumarate
Sponsor Trials
Gilead Sciences 29
National Institute of Allergy and Infectious Diseases (NIAID) 2
Erasmus Medical Center 1
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Sponsor Type

Sponsor Type for Tenofovir Alafenamide Fumarate
Sponsor Trials
Industry 32
Other 21
NIH 2
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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Fuji
Healthtrust
AstraZeneca
Express Scripts
Queensland Health
UBS
Cerilliant
Fish and Richardson

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