LABRADOR: The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine
Study Details
Study Description
Brief Summary
a multicentre phase IV study to collect evidence that a doravirine-based regimen can be safely and effectively administered to virologically suppressed HIV-infected patients undergoing bariatric suregery.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: doravirine treatment patients stable on doravirine and candidate for bariatric surgery |
Procedure: bariatric surgery
bariatric surgery
|
Outcome Measures
Primary Outcome Measures
- AUC of doravirine [24 hours]
area under the curve, doravirine
Secondary Outcome Measures
- adverse events [24 weeks]
adverse events
- HIV viral load [24 weeks]
HIV viral load
Eligibility Criteria
Criteria
Inclusion Criteria:
-
HIV-infected
-
VL suppressed <40c/ml for at least 6 months, blips are allowed
-
planned to have bariatric surgery (gastric bypass or gastric sleeve)
-
Able to sign informed consent
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Age > or equal to 18 years
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Using doravirine for at least 4 weeks prior to BS with VL < 40 copies/mL prior to the surgery
Exclusion Criteria:
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History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study or interfere with the subject's participation
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Requires or is anticipated to require any of the prohibited medications known to contradict/interact with doravirine
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Has significant hypersensitivity or other contraindication to doravirine
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Creatinine clearance <40 ml/min
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Severe liver dysfunction (Diagnosed liver cirrhosis: Child-Pugh C)
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Pregnancy or planning to be pregnant during first 6 months postbariatric surgery.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Radboud University Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LABRADOR