Back to resultsThe Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine (LABRADOR)
Primary Purpose
HIV Infections, Bariatric Surgery Candidate
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
bariatric surgery
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring doravirine, pharmacokinetics
Eligibility 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
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
doravirine treatment
Arm Description
patients stable on doravirine and candidate for bariatric surgery
Outcomes
Primary Outcome Measures
AUC of doravirine
area under the curve, doravirine
Secondary Outcome Measures
adverse events
adverse events
HIV viral load
HIV viral load
Full Information
NCT ID
NCT05536466
First Posted
September 7, 2022
Last Updated
September 9, 2022
Sponsor
Radboud University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05536466
Brief Title
The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine
Acronym
LABRADOR
Official Title
The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 30, 2022 (Anticipated)
Primary Completion Date
July 23, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Bariatric Surgery Candidate
Keywords
doravirine, pharmacokinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pharmacokinetics of doravirine will be investigated before as well as after bariatric surgery and will be compared for each patient
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
doravirine treatment
Arm Type
Experimental
Arm Description
patients stable on doravirine and candidate for bariatric surgery
Intervention Type
Procedure
Intervention Name(s)
bariatric surgery
Intervention Description
bariatric surgery
Primary Outcome Measure Information:
Title
AUC of doravirine
Description
area under the curve, doravirine
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
adverse events
Description
adverse events
Time Frame
24 weeks
Title
HIV viral load
Description
HIV viral load
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leena Zino
Phone
0031243611111
Email
leena.zino@radboudumc.nl
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine
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