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

Sponsor
Radboud University Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05536466
Collaborator
(none)
8
1
10

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
  • Procedure: bariatric surgery
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
8 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Pharmacokinetics of doravirine will be investigated before as well as after bariatric surgery and will be compared for each patientPharmacokinetics of doravirine will be investigated before as well as after bariatric surgery and will be compared for each patient
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine
Anticipated Study Start Date :
Sep 30, 2022
Anticipated Primary Completion Date :
Jul 23, 2023
Anticipated Study Completion Date :
Aug 1, 2023

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

  1. AUC of doravirine [24 hours]

    area under the curve, doravirine

Secondary Outcome Measures

  1. adverse events [24 weeks]

    adverse events

  2. HIV viral load [24 weeks]

    HIV viral load

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

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.
Responsible Party:
Radboud University Medical Center
ClinicalTrials.gov Identifier:
NCT05536466
Other Study ID Numbers:
  • LABRADOR
First Posted:
Sep 10, 2022
Last Update Posted:
Sep 10, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Radboud University Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 10, 2022