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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-30

Study Completion Date

2023-08-01

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infections Bariatric Surgery Candidate

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pharmacokinetics of doravirine will be investigated before as well as after bariatric surgery and will be compared for each patient

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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doravirine treatment

patients stable on doravirine and candidate for bariatric surgery

Group Type EXPERIMENTAL

bariatric surgery

Intervention Type PROCEDURE

bariatric surgery

Interventions

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bariatric surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No