The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine

Not Applicable

Not yet recruiting

• Conditions: Bariatric Surgery Candidate; HIV Infections
• Interventions: Procedure: bariatric surgery

• Registration Number: NCT05536466
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-07
• Study First Submitted QC: 2022-09-09
• Last Update Submitted: 2022-09-09
• Study First Posted: 2022-09-10
• Last Update Posted: 2022-09-10
• Study Start: 2022-09-30
• Primary Completion: 2023-07-23
• Study Completion: 2023-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 8

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
• Age > or equal to 18 years
• Using doravirine for at least 4 weeks prior to BS with VL < 40 copies/mL prior to the surgery

Exclusion Criteria

• 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
• Requires or is anticipated to require any of the prohibited medications known to contradict/interact with doravirine
• Has significant hypersensitivity or other contraindication to doravirine
• Creatinine clearance <40 ml/min
• Severe liver dysfunction (Diagnosed liver cirrhosis: Child-Pugh C)
• Pregnancy or planning to be pregnant during first 6 months postbariatric surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
doravirine treatment	bariatric surgery	patients stable on doravirine and candidate for bariatric surgery

Primary Outcome Measures

Name	Time	Method
AUC of doravirine	24 hours	area under the curve, doravirine

Secondary Outcome Measures

Name	Time	Method
HIV viral load	24 weeks	HIV viral load
adverse events	24 weeks	adverse events