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

September 9, 2022 updated by: Radboud University Medical Center
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: doravirine treatment
patients stable on doravirine and candidate for bariatric surgery
Procedure: bariatric surgery
bariatric surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC of doravirine
Time Frame: 24 hours
area under the curve, doravirine
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse events
Time Frame: 24 weeks
adverse events
24 weeks
HIV viral load
Time Frame: 24 weeks
HIV viral load
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 30, 2022

Primary Completion (Anticipated)

July 23, 2023

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

September 7, 2022

First Submitted That Met QC Criteria

September 9, 2022

First Posted (Actual)

September 10, 2022

Study Record Updates

Last Update Posted (Actual)

September 10, 2022

Last Update Submitted That Met QC Criteria

September 9, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LABRADOR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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