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Generated: December 16, 2018

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CLINICAL TRIALS PROFILE FOR COBICISTAT

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Clinical Trials for Cobicistat

Trial ID Title Status Sponsor Phase Summary
NCT00855335 A Single-arm, Open-label, Study to Assess the Pharmacokinetics of Darunavir and Ritonavir, Darunavir and Cobicistat, Etravirine, and Rilpivirine in HIV-1 Infected Pregnant Women Recruiting Janssen Scientific Affairs, LLC Phase 3 The purpose of this study is to study how changes in the body during pregnancy influence the blood levels of TMC114 (darunavir) and ritonavir taken together, darunavir and cobicistat taken as a fixed-dose combination, TMC125 (etravirine) taken alone or with darunavir and ritonavir or rilpivirine in patients with human immunodeficiency virus-1 (HIV-1). This study will examine how these drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time. Any pregnant woman who is currently receiving darunavir with ritonavir, darunavir with cobicistat, etravirine or rilpivirine for HIV-1, and who meets the eligibility criteria for the study, will be allowed to enroll. Patients must be willing to remain on study medication during the course of their pregnancy, and 12 weeks postpartum. The information collected may help answer questions about how to best prescribe these three drugs for pregnant women.
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).
NCT00892437 Safety and Efficacy of Cobicistat-boosted Atazanavir Compared to Ritonavir-boosted Atazanavir in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults Completed Gilead Sciences Phase 2 The objective of this study is to evaluate the safety and efficacy of a regimen containing cobicistat-boosted atazanavir (ATV+COBI) plus emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF) versus ritonavir-boosted atazanavir (ATV+RTV) plus FTC/TDF in HIV-1 infected, antiretroviral treatment-naive adults. Participants will be randomized in a 2:1 ratio. 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, at which point all participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive ATV+COBI+FTC/TDF until COBI tablets become 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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Cobicistat

Condition Name

Condition Name for Cobicistat
Intervention Trials
HIV 24
HIV Infections 23
Acquired Immunodeficiency Syndrome 11
HIV-1 Infection 10
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Condition MeSH

Condition MeSH for Cobicistat
Intervention Trials
HIV Infections 36
Acquired Immunodeficiency Syndrome 21
Immunologic Deficiency Syndromes 20
Hepatitis C 5
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Clinical Trial Locations for Cobicistat

Trials by Country

Trials by Country for Cobicistat
Location Trials
United States 505
Canada 40
United Kingdom 24
Spain 20
Puerto Rico 18
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Trials by US State

Trials by US State for Cobicistat
Location Trials
Florida 33
Texas 32
California 32
North Carolina 27
Georgia 27
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Clinical Trial Progress for Cobicistat

Clinical Trial Phase

Clinical Trial Phase for Cobicistat
Clinical Trial Phase Trials
Phase 4 18
Phase 3 32
Phase 2/Phase 3 5
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Clinical Trial Status

Clinical Trial Status for Cobicistat
Clinical Trial Phase Trials
Completed 27
Recruiting 25
Active, not recruiting 18
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Clinical Trial Sponsors for Cobicistat

Sponsor Name

Sponsor Name for Cobicistat
Sponsor Trials
Gilead Sciences 44
Janssen Scientific Affairs, LLC 5
Bristol-Myers Squibb 5
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Sponsor Type

Sponsor Type for Cobicistat
Sponsor Trials
Industry 71
Other 44
NIH 3
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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Julphar
McKinsey
Fuji
Moodys
Daiichi Sankyo
Medtronic
Merck
McKesson

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