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Stribild

DRUG12 trials

Sponsors

Gilead Sciences, University of California, San Diego, University of Hawaii, Vancouver Infectious Diseases Centre, Radboud University Medical Center

Conditions

AIDSAcquired Immunodeficiency SyndromeHIVHIV InfectionsHIV-DDIIllicit Drug UserSleep Disorders

Phase 1

Bioequivalence of Crushed Stribild With a Normal Breakfast or With Drip Feed Compared to the Whole Tablet
CompletedNCT02325934
Radboud University Medical CenterHIV
Start: 2015-02-28End: 2015-02-28Updated: 2021-03-15
Interaction With HIV Antiretroviral Agents
CompletedNCT02556268
BayerHIV-DDI
Start: 2016-02-23End: 2016-12-07Updated: 2017-12-06

Phase 2

Study of the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
CompletedNCT00869557
Gilead SciencesHIV, HIV Infections
Start: 2009-04-30End: 2013-09-30Updated: 2014-06-04

Phase 3

Study to Evaluate the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
CompletedNCT01095796
Gilead SciencesHIV, HIV Infections
Start: 2010-03-31End: 2014-09-30Updated: 2015-11-11
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
CompletedNCT01106586
Gilead SciencesHIV, HIV Infections
Start: 2010-04-30End: 2014-09-30Updated: 2015-11-11
Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor Plus Emtricitabine/Tenofovir Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients
CompletedNCT01475838
Gilead SciencesAcquired Immunodeficiency Syndrome, HIV Infections
Start: 2011-11-30End: 2014-12-31Updated: 2016-06-08
Study to Evaluate Switching From Regimens Consisting of a Nonnucleoside Reverse Transcriptase Inhibitor Plus Emtricitabine and Tenofovir DF to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients
CompletedNCT01495702
Gilead SciencesAcquired Immunodeficiency Syndrome, HIV Infections
Start: 2011-12-31End: 2014-12-31Updated: 2016-01-07
Open-Label Pilot Study to Evaluate Switching From a Regimen Consisting of Raltegravir Plus Emtricitabine/Tenofovir DF Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients
CompletedNCT01533259
Gilead SciencesAcquired Immunodeficiency Syndrome, HIV Infections
Start: 2012-01-31End: 2013-07-31Updated: 2015-01-26

Phase 4

Sleep and Cognition After Atripla to Stribild Switch
NCT02283060
University of HawaiiHIV
Start: 2014-09-30End: 2016-08-31Target: 30Updated: 2016-03-14
Atripla to Stribild Switch Study to Evaluate Sleep Disturbances
CompletedNCT02477527
Midtown Medical Center, Tampa, FLAIDS, HIV, Sleep Disorders
Start: 2015-02-28End: 2016-01-31Updated: 2017-07-28

Unknown Phase

Elvitegravir (EVG) Cerebrospinal Fluid (CSF) Pharmacokinetics in HIV-Infected Individuals
CompletedNCT02251236
University of California, San DiegoHIV
Start: 2016-01-31End: 2017-01-18Updated: 2019-10-31
STRIBILD in Non-Nucleoside Resistant Patients (SINNR STUDY)
NCT02306577
Vancouver Infectious Diseases CentreHIV, Illicit Drug User
Start: 2014-11-30End: 2016-07-31Target: 30Updated: 2015-06-03

Related Papers

Switching to Tenofovir Alafenamide in Elvitegravir-Based Regimens: Pharmacokinetics and Antiviral Activity in Cerebrospinal Fluid
Clinical Infectious Diseases2019-09-1811 citations
Pharmacokinetic (PK) interaction of fixed-dose combination (FDC) antiretrovirals (ARV) with riociguat (rio)
2018-09-151 citations
Patient-Reported Symptoms over 48 Weeks in a Randomized, Open-Label, Phase 3b Non-inferiority Trial of Adults with HIV Switching to Coformulated Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir DF Versus Continuation of Ritonavir-Boosted Protease Inhibitor with Emtricitabine and Tenofovir DF.
2015-10-019 citations
Simplification to coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus continuation of ritonavir-boosted protease inhibitor with emtricitabine and tenofovir in adults with virologically suppressed HIV (STRATEGY-PI): 48 week results of a randomised, open-label, phase 3b, non-inferiority trial.
2014-06-0597 citations
Switching to coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus continuation of non-nucleoside reverse transcriptase inhibitor with emtricitabine and tenofovir in virologically suppressed adults with HIV (STRATEGY-NNRTI): 48 week results of a randomised, open-label, phase 3b non-inferiority trial.
2014-06-0578 citations
Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus co-formulated efavirenz, emtricitabine, and tenofovir for initial treatment of HIV-1 infection: a randomised, double-blind, phase 3 trial, analysis of results after 48 weeks.
2012-06-01331 citations
Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate versus ritonavir-boosted atazanavir plus co-formulated emtricitabine and tenofovir disoproxil fumarate for initial treatment of HIV-1 infection: a randomised, double-blind, phase 3, non-inferiority trial.
2012-06-01260 citations