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Generated: December 17, 2018

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CLINICAL TRIALS PROFILE FOR EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

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Clinical Trials for Emtricitabine; Tenofovir Alafenamide Fumarate

Trial ID Title Status Sponsor Phase Summary
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.
NCT02121795 Switch Study to Evaluate F/TAF in HIV-1 Positive Participants Who Are Virologically Suppressed on Regimens Containing FTC/TDF Active, not recruiting Gilead Sciences Phase 3 This study will evaluate the efficacy of switching from emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) fixed dose combination (FDC) to emtricitabine/tenofovir alafenamide (F/TAF) FDC in HIV-1 positive participants who are virologically suppressed on regimens containing FTC/TDF. This study will consist of a 96 week double-blind treatment period. After Week 96, all participants will continue on blinded study drug treatment and attend visits every 12 weeks until treatment assignments are unblinded. All participants will return for an unblinding visit and will be given the option to receive open-label F/TAF and attend visits every 12 weeks until F/TAF is commercially available, or the sponsor terminates the F/TAF clinical development program.
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.
NCT02251236 Elvitegravir (EVG) Cerebrospinal Fluid (CSF) Pharmacokinetics in HIV-Infected Individuals Active, not recruiting University at Buffalo 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 Emtricitabine; Tenofovir Alafenamide Fumarate

Condition Name

Condition Name for Emtricitabine; Tenofovir Alafenamide Fumarate
Intervention Trials
HIV-1 Infection 7
Hiv 6
HIV Infections 5
HIV-1-infection 3
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Condition MeSH

Condition MeSH for Emtricitabine; Tenofovir Alafenamide Fumarate
Intervention Trials
HIV Infections 8
Immunologic Deficiency Syndromes 5
Acquired Immunodeficiency Syndrome 5
Coinfection 2
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Clinical Trial Locations for Emtricitabine; Tenofovir Alafenamide Fumarate

Trials by Country

Trials by Country for Emtricitabine; Tenofovir Alafenamide Fumarate
Location Trials
United States 240
Canada 28
Puerto Rico 12
United Kingdom 11
France 10
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Trials by US State

Trials by US State for Emtricitabine; Tenofovir Alafenamide Fumarate
Location Trials
California 15
Florida 14
Missouri 13
Georgia 13
District of Columbia 12
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Clinical Trial Progress for Emtricitabine; Tenofovir Alafenamide Fumarate

Clinical Trial Phase

Clinical Trial Phase for Emtricitabine; Tenofovir Alafenamide Fumarate
Clinical Trial Phase Trials
Phase 4 3
Phase 3 15
Phase 2 4
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Clinical Trial Status

Clinical Trial Status for Emtricitabine; Tenofovir Alafenamide Fumarate
Clinical Trial Phase Trials
Active, not recruiting 10
Recruiting 10
Not yet recruiting 4
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Clinical Trial Sponsors for Emtricitabine; Tenofovir Alafenamide Fumarate

Sponsor Name

Sponsor Name for Emtricitabine; Tenofovir Alafenamide Fumarate
Sponsor Trials
Gilead Sciences 20
National Institute of Allergy and Infectious Diseases (NIAID) 2
Midland Research Group, Inc. 1
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Sponsor Type

Sponsor Type for Emtricitabine; Tenofovir Alafenamide Fumarate
Sponsor Trials
Industry 23
Other 13
NIH 2
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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Cerilliant
QuintilesIMS
Julphar
US Department of Justice
Accenture
Fish and Richardson
Boehringer Ingelheim
Baxter

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