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CLINICAL TRIALS PROFILE FOR COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

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Clinical Trials for Cobicistat; Elvitegravir; 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.
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.
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.
NCT02251236 Elvitegravir (EVG) Cerebrospinal Fluid (CSF) Pharmacokinetics in HIV-Infected Individuals Active, not recruiting University of California, San Diego 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.
NCT02616029 Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) in Virologically-Suppressed HIV-1 Infected Adults Harboring the Archived Isolated NRTI Resistance Mutation M184V/M184I Recruiting Gilead Sciences Phase 3 This study will evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed dose combination (FDC) after switching from a stable regimen consisting of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) plus a third antiretroviral agent in participants harboring the archived nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) resistance mutation M184V and/or M184I in HIV-1 reverse transcriptase.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Alafenamide Fumarate

Condition Name

Condition Name for Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Alafenamide Fumarate
Intervention Trials
HIV-1 Infection 3
HIV Infections 3
HIV 3
HIV/AIDS 2
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Condition MeSH

Condition MeSH for Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Alafenamide Fumarate
Intervention Trials
HIV Infections 3
Immunologic Deficiency Syndromes 1
Drug-Related Side Effects and Adverse Reactions 1
Acquired Immunodeficiency Syndrome 1
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Clinical Trial Locations for Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Alafenamide Fumarate

Trials by Country

Trials by Country for Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Alafenamide Fumarate
Location Trials
United States 88
Canada 7
Italy 5
Spain 4
United Kingdom 4
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Trials by US State

Trials by US State for Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Alafenamide Fumarate
Location Trials
California 7
Missouri 5
Georgia 5
Florida 5
Washington 4
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Clinical Trial Progress for Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Alafenamide Fumarate

Clinical Trial Phase

Clinical Trial Phase for Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Alafenamide Fumarate
Clinical Trial Phase Trials
Phase 3 6
Phase 2 2
Phase 1/Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Alafenamide Fumarate
Clinical Trial Phase Trials
Recruiting 5
Active, not recruiting 4
Completed 1
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Clinical Trial Sponsors for Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Alafenamide Fumarate

Sponsor Name

Sponsor Name for Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Alafenamide Fumarate
Sponsor Trials
Gilead Sciences 10
Brigham and Women's Hospital 1
Analysis Group, Inc. 1
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Sponsor Type

Sponsor Type for Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Alafenamide Fumarate
Sponsor Trials
Industry 11
Other 7
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