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Generated: December 15, 2018

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

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Clinical Trials for Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Disoproxil Fumarate

Trial ID Title Status Sponsor Phase Summary
NCT00869557 Study of the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults Completed Gilead Sciences Phase 2 The objective of this double-blinded, multicenter, randomized, active-controlled study is to evaluate the safety and efficacy of Stribild, a single-tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/GS-9350 (cobicistat; COBI)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus efavirenz (EFV)/FTC/TDF (Atripla) in HIV-1 infected, antiretroviral treatment-naive adult participants. Stribild offers an alternative STR for patients who are not candidates for non-nucleoside reverse transcriptor (NNRTI)-based STRs. Participants will be randomized in a 2:1 ratio to receive Stribild or Atripla. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL) at screening. After Week 48, participants will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments are unblinded (Week 60), at which point all participants will attend an Unblinding Visit and be given the option to participate in an open-label rollover extension (the extension is scheduled to be open until Stribild becomes commercially available, or until Gilead Sciences elects to terminate the study).
NCT01095796 Study to Evaluate the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults Completed Gilead Sciences Phase 3 To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/cobicistat (COBI [GS-9350])/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus efavirenz (EFV)/FTC/TDF (Atripla®) in HIV-1 infected, antiretroviral treatment-naive adults. Stribild offers an alternative STR for patients who are not candidates for non-nucleoside reverse transcriptor-based STRs.
NCT01106586 Study to Evaluate the Safety and Efficacy of Stribild Versus Ritonavir-Boosted Atazanavir Plus Truvada in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults Completed Gilead Sciences Phase 3 To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/cobicistat (COBI [GS-9350])/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus ritonavir-boosted atazanavir (ATV/r) plus the standard of care nucleoside reverse transcriptase inhibitor (NRTI) backbone FTC/TDF (Truvada®). ATV/r + FTC/TDF was selected as the active comparator for this study as it is a preferred protease inhibitor-based regimen in guidelines for the treatment of HIV-1 infected, antiretroviral treatment-naive adults.
NCT01475838 Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor Plus Emtricitabine/Tenofovir Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppre Completed Gilead Sciences Phase 3 This study will evaluate the non-inferiority of Stribild® (elvitegravir/cobicistat/ emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative to regimens consisting of a protease inhibitor (PI) boosted with ritonavir (RTV) plus Truvada® (FTC/TDF) fixed-dose combination in maintaining HIV-1 RNA < 50 copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of the two regimens through 96 weeks of treatment.
NCT01495702 Study to Evaluate Switching From Regimens Consisting of a Nonnucleoside Reverse Transcriptase Inhibitor Plus Emtricitabine and Tenofovir DF to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, H Completed Gilead Sciences Phase 3 This study will evaluate the noninferiority of Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative to regimens consisting of a nonnucleoside reverse transcriptase inhibitor (NNRTI) plus Truvada® (FTC/TDF) in maintaining HIV-1 RNA < 50 copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of the two regimens through 96 weeks of treatment.
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.
NCT01533259 Open-Label Pilot Study to Evaluate Switching From a Regimen Consisting of Raltegravir Plus Emtricitabine/Tenofovir DF Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, Completed Gilead Sciences Phase 3 This study will evaluate the efficacy of Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF)) single-tablet regimen (STR) after switching from a regimen consisting of raltegravir plus Truvada® (FTC/TDF) at baseline in maintaining HIV-1 RNA < 50 copies/mL at Week 12 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of Stribild over 24 and 48 weeks of treatment.
Trial ID Title Status Sponsor Phase Summary

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

Condition Name

Condition Name for Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Disoproxil Fumarate
Intervention Trials
HIV Infections 11
HIV 9
Acquired Immunodeficiency Syndrome 6
HIV-1 Infection 3
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Condition MeSH

Condition MeSH for Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Disoproxil Fumarate
Intervention Trials
HIV Infections 14
Acquired Immunodeficiency Syndrome 8
Immunologic Deficiency Syndromes 7
Coinfection 1
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Clinical Trial Locations for Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Disoproxil Fumarate

Trials by Country

Trials by Country for Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Disoproxil Fumarate
Location Trials
United States 212
Canada 16
United Kingdom 11
Puerto Rico 9
Italy 9
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Trials by US State

Trials by US State for Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Disoproxil Fumarate
Location Trials
California 15
Florida 13
North Carolina 12
Texas 11
New York 11
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Clinical Trial Progress for Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Disoproxil Fumarate

Clinical Trial Phase

Clinical Trial Phase for Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Disoproxil Fumarate
Clinical Trial Phase Trials
Phase 4 5
Phase 3 13
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Disoproxil Fumarate
Clinical Trial Phase Trials
Active, not recruiting 10
Recruiting 7
Completed 7
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Clinical Trial Sponsors for Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Disoproxil Fumarate

Sponsor Name

Sponsor Name for Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Disoproxil Fumarate
Sponsor Trials
Gilead Sciences 22
Clinique des Maladies Infectieuses Ibrahima DIOP Mar/CRCF, Centre Hospitalier Universitaire de Fann 1
Merck Sharp & Dohme Corp. 1
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Sponsor Type

Sponsor Type for Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Disoproxil Fumarate
Sponsor Trials
Industry 24
Other 14
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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Cipla
Cerilliant
UBS
Harvard Business School
Express Scripts
McKesson
Colorcon
Argus Health

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