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Last Updated: August 10, 2020

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CLINICAL TRIALS PROFILE FOR COBICISTAT; DARUNAVIR

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All Clinical Trials for Cobicistat; Darunavir

Trial ID Title Status Sponsor Phase Start Date 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 2009-04-01 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.
NCT01440569 Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults Completed Janssen Research & Development, LLC Phase 3 2011-09-01 This study is to evaluate the safety and tolerability of cobicistat-boosted darunavir plus two fully active nucleoside analogue reverse transcriptase inhibitors in HIV 1 infected, antiretroviral treatment-naive and treatment-experienced adults with no darunavir (DRV) resistance-associated mutations. After the Week 48 Visit, participants will be given the option to participate in an open-label rollover phase to receive cobicistat and attend visits every 12 weeks until it becomes commercially available, or until Gilead Sciences elects to terminate development of cobicistat.
NCT01440569 Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults Completed Gilead Sciences Phase 3 2011-09-01 This study is to evaluate the safety and tolerability of cobicistat-boosted darunavir plus two fully active nucleoside analogue reverse transcriptase inhibitors in HIV 1 infected, antiretroviral treatment-naive and treatment-experienced adults with no darunavir (DRV) resistance-associated mutations. After the Week 48 Visit, participants will be given the option to participate in an open-label rollover phase to receive cobicistat and attend visits every 12 weeks until it becomes commercially available, or until Gilead Sciences elects to terminate development of cobicistat.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cobicistat; Darunavir

Condition Name

Condition Name for Cobicistat; Darunavir
Intervention Trials
HIV Infections 9
Healthy 6
HIV-1 5
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Condition MeSH

Condition MeSH for Cobicistat; Darunavir
Intervention Trials
HIV Infections 17
Acquired Immunodeficiency Syndrome 8
Immunologic Deficiency Syndromes 7
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Clinical Trial Locations for Cobicistat; Darunavir

Trials by Country

Trials by Country for Cobicistat; Darunavir
Location Trials
United States 145
Spain 13
Canada 12
Belgium 7
Puerto Rico 5
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Trials by US State

Trials by US State for Cobicistat; Darunavir
Location Trials
Texas 12
Georgia 9
California 8
Arizona 8
Florida 8
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Clinical Trial Progress for Cobicistat; Darunavir

Clinical Trial Phase

Clinical Trial Phase for Cobicistat; Darunavir
Clinical Trial Phase Trials
Phase 4 16
Phase 3 10
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Cobicistat; Darunavir
Clinical Trial Phase Trials
Not yet recruiting 19
Recruiting 14
Completed 10
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Clinical Trial Sponsors for Cobicistat; Darunavir

Sponsor Name

Sponsor Name for Cobicistat; Darunavir
Sponsor Trials
Gilead Sciences 7
Janssen Scientific Affairs, LLC 7
ViiV Healthcare 3
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Sponsor Type

Sponsor Type for Cobicistat; Darunavir
Sponsor Trials
Industry 38
Other 36
NIH 2
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