You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Medtronic
Colorcon
Harvard Business School
Merck
Moodys

Last Updated: May 16, 2021

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR COBICISTAT; DARUNAVIR

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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.
NCT01565850 D/C/F/TAF Versus COBI-boosted DRV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment Naive Adults Completed Gilead Sciences Phase 2 2012-04-01 This study is to evaluate the safety and efficacy darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC) tablet versus darunavir (DRV)+cobicistat (COBI)+emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) in HIV-1 infected, antiretroviral treatment-naive adults as determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 24.
NCT01619527 A Study to Assess the Bioequivalence of Darunavir When Co-Administrated With Cobicistat Under Fed and Fasted Conditions Completed Janssen R&D Ireland Phase 1 2012-04-01 The purpose of this study is to evaluate the single-dose pharmacokinetics and bioequivalence of darunavir 800 mg when administered as a fixed dose combination relative to 2 x 400 mg tablets of the commercial tablet formulation, in the presence of 150 mg cobicistat, (under fed and fasted conditions) in healthy participants.
NCT01968551 Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) Plus Darunavir (DRV) in Treatmen Completed Gilead Sciences Phase 3 2013-09-01 The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed dose combination (FDC) plus DRV relative to current antiretroviral regimens (ARV) in virologically suppressed, HIV-1 positive participants with HIV-1 RNA <50 copies/mL at Week 24. This study consists of 48 weeks of open-label phase followed by an optional extension phase in which all the participants will receive E/C/F/TAF+DRV.
>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 8
HIV-1 5
HIV 5
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Cobicistat; Darunavir
Intervention Trials
HIV Infections 17
Acquired Immunodeficiency Syndrome 8
Immunologic Deficiency Syndromes 7
Infection 4
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Cobicistat; Darunavir

Trials by Country

Trials by Country for Cobicistat; Darunavir
Location Trials
United States 163
Spain 13
Canada 12
Belgium 8
United Kingdom 5
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Cobicistat; Darunavir
Location Trials
Texas 13
Georgia 10
California 9
Florida 9
District of Columbia 8
This preview shows a limited data set
Subscribe for full access, or try a Trial

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
[disabled in preview] 24
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Cobicistat; Darunavir
Clinical Trial Phase Trials
Not yet recruiting 21
Recruiting 14
Completed 10
[disabled in preview] 8
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Cobicistat; Darunavir

Sponsor Name

Sponsor Name for Cobicistat; Darunavir
Sponsor Trials
Gilead Sciences 7
Janssen Scientific Affairs, LLC 7
Janssen Research & Development, LLC 5
[disabled in preview] 9
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Cobicistat; Darunavir
Sponsor Trials
Industry 40
Other 36
NIH 2
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKinsey
AstraZeneca
Merck
Johnson and Johnson
Dow
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.