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

Radboud University Medical Center

Status

Not yet enrolling

Conditions

Bariatric Surgery Candidate

HIV Infections

Treatments

Procedure: bariatric surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT05536466

LABRADOR

Details and patient eligibility

About

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.

Enrollment

8 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.