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Generated: December 16, 2018

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CLINICAL TRIALS PROFILE FOR ELVITEGRAVIR

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Clinical Trials for Elvitegravir

Trial ID Title Status Sponsor Phase Summary
NCT00445146 Safety of EVG+RTV Administered With Other Antiretroviral Agents for the Treatment of HIV-1 Infection Completed Gilead Sciences Phase 2 The main objective of this study is to observe the long-term safety of elvitegravir (EVG) boosted with ritonavir (RTV) in combination with other antiretroviral (ARV) agents in participants who have completed a prior EVG+RTV treatment study.
NCT00708162 Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Elvitegravir Versus Raltegravir Completed Gilead Sciences Phase 3 The purpose of this study is to compare the safety, tolerability and efficacy of a regimen containing once-daily elvitegravir (EVG) versus twice-daily raltegravir (RAL) added to a background regimen (1 fully-active ritonavir (RTV)-boosted protease inhibitor (PI) plus 1 or 2 additional antiretroviral (ARV) agents) in HIV-1 infected, ARV treatment-experienced adults who have documented resistance, or at least six months experience prior to screening with two or more different classes of ARV agents. Participants will be randomized in a 1:1 ratio to receive EVG plus background regimen (Elvitegravir group), or raltegravir plus background regimen (Raltegravir group). Due to known drug interactions, participants in the Elvitegravir group receiving RTV-boosted atazanavir (ATV) or RTV-boosted lopinavir (LPV) as part of their background regimen will receive elvitegravir at a lower dose (85 mg).
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).
NCT00944307 Effect of Antacids on the Pharmacokinetics of Raltegravir Completed University of Colorado, Denver N/A The purpose of this study is to test whether there is a drug interaction between raltegravir (a medicine used to treat the human immunodeficiency virus or HIV) and antacids.
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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Elvitegravir

Condition Name

Condition Name for Elvitegravir
Intervention Trials
HIV Infections 19
HIV 18
Acquired Immunodeficiency Syndrome 8
HIV-1 Infection 8
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Condition MeSH

Condition MeSH for Elvitegravir
Intervention Trials
HIV Infections 29
Acquired Immunodeficiency Syndrome 16
Immunologic Deficiency Syndromes 14
Infection 4
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Clinical Trial Locations for Elvitegravir

Trials by Country

Trials by Country for Elvitegravir
Location Trials
United States 408
Canada 36
Italy 19
Spain 19
United Kingdom 17
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Trials by US State

Trials by US State for Elvitegravir
Location Trials
Florida 26
California 26
North Carolina 24
Texas 22
New York 22
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Clinical Trial Progress for Elvitegravir

Clinical Trial Phase

Clinical Trial Phase for Elvitegravir
Clinical Trial Phase Trials
Phase 4 11
Phase 3 27
Phase 2/Phase 3 6
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Clinical Trial Status

Clinical Trial Status for Elvitegravir
Clinical Trial Phase Trials
Completed 18
Active, not recruiting 16
Recruiting 15
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Clinical Trial Sponsors for Elvitegravir

Sponsor Name

Sponsor Name for Elvitegravir
Sponsor Trials
Gilead Sciences 41
ViiV Healthcare 4
GlaxoSmithKline 2
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Sponsor Type

Sponsor Type for Elvitegravir
Sponsor Trials
Industry 51
Other 33
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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Johnson and Johnson
Fuji
Medtronic
Deloitte
Chinese Patent Office
Chubb
Moodys
Citi

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