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NCT05536466 Clinical Trial

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

HIV Infections Clinical Trial

— LABRADOR  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05536466
Other study ID # LABRADOR
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 30, 2022
Est. completion date August 1, 2023

Study information
Verified date September 2022
Source Radboud University Medical Center
Contact Leena Zino
Phone 0031243611111
Email leena.zino@radboudumc.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 8
Est. completion date August 1, 2023
Est. primary completion date July 23, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• bariatric surgery
bariatric surgery

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Radboud University Medical Center

Outcome
Type Measure Description Time frame Safety issue
Primary AUC of doravirine area under the curve, doravirine 24 hours
Secondary adverse events adverse events 24 weeks
Secondary HIV viral load HIV viral load 24 weeks
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