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COBI

DRUG8 trials

Sponsors

Gilead Sciences, Janssen Research & Development, LLC

Conditions

Acquired Immunodeficiency SyndromeHIVHIV InfectionsHIV-1 InfectionHealthy

Phase 1

A Study of Darunavir in the Presence of Cobicistat When Administered as a Fixed Dose Combination Compared to the Co-administration of the Separate Available Formulations of Darunavir and Cobicistat Under Fed Conditions in Healthy Participants
CompletedNCT05378906
Janssen Research & Development, LLCHealthy
Start: 2022-06-07End: 2022-09-28Updated: 2022-10-26

Phase 2

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
CompletedNCT00892437
Gilead SciencesHIV-1 Infection
Start: 2009-05-31End: 2015-01-31Updated: 2016-02-15
D/C/F/TAF Versus COBI-boosted DRV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment Naive Adults
CompletedNCT01565850
Gilead SciencesAcquired Immunodeficiency Syndrome, HIV Infections
Start: 2012-04-30End: 2014-02-28Updated: 2016-04-11

Phase 3

Safety and Efficacy of COBI-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
CompletedNCT01108510
Gilead SciencesHIV, HIV Infections
Start: 2010-04-30End: 2015-04-30Updated: 2016-05-23
Cobicistat-containing Highly Active Antiretroviral Regimens in HIV-1 Infected Patients With Mild to Moderate Renal Impairment
CompletedNCT01363011
Gilead SciencesAcquired Immunodeficiency Syndrome, HIV Infections
Start: 2011-05-31End: 2015-02-28Updated: 2016-05-02
Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults
CompletedNCT01440569
Gilead SciencesAcquired Immunodeficiency Syndrome, HIV Infections
Start: 2011-09-30End: 2015-10-31Updated: 2016-12-14
Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants
CompletedNCT01815736
Gilead SciencesHIV, HIV Infections
Start: 2013-03-27End: 2020-04-01Updated: 2021-04-13
Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected Adults
CompletedNCT02603107
Gilead SciencesHIV-1 Infection
Start: 2015-11-20End: 2019-12-23Updated: 2020-12-29

Related Papers

Efficacy and safety of switching to bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed Asian adults living with HIV: A pooled analysis from three international phase III randomized trials
HIV Medicine2022-08-178 citations
Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in antiretroviral regimens for virologically suppressed adults with HIV-1 infection: a randomised, active-controlled, multicentre, open-label, phase 3, non-inferiority study
Carolina Digital Repository (University of North Carolina at Chapel Hill)2020-04-22
Efficacy and safety of switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from boosted protease inhibitor-based regimens in virologically suppressed adults with HIV-1: 48 week results of a randomised, open-label, multicentre, phase 3, non-inferiority trial.
2018-06-18125 citations
Superior Efficacy and Improved Renal and Bone Safety After Switching from a Tenofovir Disoproxil Fumarate- to a Tenofovir Alafenamide-Based Regimen Through 96 Weeks of Treatment
AIDS Research and Human Retroviruses2018-01-2588 citations
HIV-1 resistance rarely observed in patients using darunavir once-daily regimens across clinical studies.
2017-11-1632 citations
Switching from tenofovir disoproxil fumarate to tenofovir alafenamide coformulated with rilpivirine and emtricitabine in virally suppressed adults with HIV-1 infection: a randomised, double-blind, multicentre, phase 3b, non-inferiority study.
2017-03-0257 citations
Atazanavir Plus Cobicistat: Week 48 and Week 144 Subgroup Analyses of a Phase 3, Randomized, Double-Blind, Active-Controlled Trial.
2017-01-015 citations
Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in antiretroviral regimens for virologically suppressed adults with HIV-1 infection: a randomised, active-controlled, multicentre, open-label, phase 3, non-inferiority study.
2015-11-02223 citations
Cobicistat-boosted darunavir in HIV-1-infected adults: week 48 results of a Phase IIIb, open-label single-arm trial.
2014-12-0150 citations
Phase IIIb, open‐label single‐arm trial of darunavir/cobicistat (DRV/COBI): Week 48 subgroup analysis of HIV‐1‐infected treatment‐nave adults
Journal of the International AIDS Society2014-11-0112 citations
No Resistance and Improved Renal and Bone Profiles with a Single-Table Regimen of D/C/F/TAF
MD Conference Express2014-11-01