A Retrospective Study to Evaluate the Safety and Efficacy of a Nucleoside-Sparing Regimen of Darunavir, Ritonavir, and Dolutegravir
NCT ID: NCT03198884
Last Updated: 2020-09-01
Study Results
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View full resultsBasic Information
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COMPLETED
20 participants
OBSERVATIONAL
2017-01-01
2018-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Interventions
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Darunavir 800 MG, Norvir 100 MG, Dolutegravir 50 MG
Eligibility Criteria
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Inclusion Criteria
* Received a regimen of darunavir 800 mg/ritonavir 100 mg in combination with dolutegravir 50 mg QD for ≥24 weeks as documented in EMR
* Laboratory reports (CD4, viral load, SrCr) available at time points +/- 4 6 weeks from 12, 24, 36, 48 weeks from start of regimen
* Resistance data (if applicable)
Exclusion Criteria
* Patients receiving darunavir/ritonavir + DTG+NRTI's
* Missing laboratory data in ≥2 study time points
* Patients missing more than five doses over two weeks prior study visit
18 Years
ALL
No
Sponsors
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Janssen Scientific Affairs, LLC
INDUSTRY
Southern Illinois Healthcare Foundation
OTHER
Responsible Party
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John Verna
Physician Assistant
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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16-1108-100C
Identifier Type: -
Identifier Source: org_study_id
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