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14 results for “bictegravir”
Compendial testing data of bictegravir and cabotegravir
<p>ISO/IEC 17043:2015, specifies general requirements for the competence of providers and development and operation of proficiency testing schemes. As a requirement of ISO/IEC 17043:2015 accreditation, the Clinical Pharmacology Quality Assurance Program uses ISO 17034 certified reference materials (CRMs) to produce proficiency testing materials. When CRMs that meet the ISO/IEC 17034 standard are not available or are prohibitively expensive, the purity and identity of non-certified standards must be authenticated by compendial testing to establish fit for intended use. Here, we report on a compendial testing approach used to assess whether standard reference materials for bictegravir and cabotegravir, two emerging drugs used in the treatment of HIV infection, are suitable for proficiency testing. Our approach uses high performance liquid chromatography and thermogravimetric analysis to evaluate purity of the materials and high-resolution mass spectrometry and proton nuclear magnetic resonance spectroscopy to establish molecular identity. Using this approach, we were able to certify standard reference materials for bictegravir and cabotegravir that are suitable for proficiency testing, providing some lower-costs alternatives.</p>
Safety and Efficacy of Bictegravir + Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
ClinicalTrials.gov study NCT02397694. IPD Sharing: NO. Countries: 1. Publications: 2.
Compendial testing data of bictegravir and cabotegravir
Open the record for dataset details and reuse information.
Bictegravir in the Elderly Living With HIV (BICEP)
ClinicalTrials.gov study NCT05064020. IPD Sharing: YES. Countries: 1. Publications: 13.
Effectiveness, Safety, Adherence, and Health-related Quality of Life in HIV-1 Infected Adults Receiving Bictegravir/ Emtricitabine/Tenofovir Alafenamide
ClinicalTrials.gov study NCT03580668. IPD Sharing: NO. Countries: 1. Publications: 1.
Effectiveness, Safety, Adherence, and Health-related Quality of Life in HIV-1 Infected Adults Receiving Bictegravir/ Emtricitabine/Tenofovir Alafenamide (B/F/TAF)
ClinicalTrials.gov study NCT04009057. IPD Sharing: NO. Countries: 1. Publications: 1.
Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Bictegravir (GS-9883) in Human Immunodeficiency Virus (HIV)-1 Infected Participants
ClinicalTrials.gov study NCT02275065. IPD Sharing: Not stated. Countries: 1. Publications: 0.
Pharmacokinetics of Bictegravir in Adults With Normal and Impaired Renal Function
ClinicalTrials.gov study NCT02400307. IPD Sharing: Not stated. Countries: 2. Publications: 0.
A Study of the Pharmacokinetic and Pharmacodynamic Interactions Between Bictegravir, Tenofovir Alafenamide and Rifapentine in Healthy Adult Subjects
ClinicalTrials.gov study NCT04551573. IPD Sharing: YES. Countries: 1. Publications: 0.
Prospective Multicenter Study of the Relationship Between Virological Effectiveness and Compliance in HIV-1-infected Patients Treated With Bictegravir
ClinicalTrials.gov study NCT06902142. IPD Sharing: UNDECIDED. Countries: 1. Publications: 0.
Initiation of First-line Antiretroviral Treatment With TENOFOVIR ALAFENAMIDE - EMTRICITABINE - BICTEGRAVIR at the First Clinical Contact in France: Trial IMEA 055 - FAST
ClinicalTrials.gov study NCT03858478. IPD Sharing: Not stated. Countries: 1. Publications: 0.
Neurological Monitoring in Patients Switching From Dolutegravir Based Regimen to Bictegravir Based Regimen
ClinicalTrials.gov study NCT04155554. IPD Sharing: NO. Countries: 1. Publications: 0.
Incidence of Metabolic Syndrome in People Living With HIV Without ExperienCe to ART Who Start DoLutegravir Based-Regimen Compared With BictegrAvir Based-RegimeN
ClinicalTrials.gov study NCT06629480. IPD Sharing: UNDECIDED. Countries: 1. Publications: 0.
Evaluation of the Neurological and Psychiatric Adverse Events of Dolutegravir and Bictegravir in Real Life
ClinicalTrials.gov study NCT03964584. IPD Sharing: NO. Countries: 0. Publications: 0.
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OpenNeuro
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