Bariatric Surgery Candidate, HIV Infections
Conditions
Keywords
doravirine, pharmacokinetics
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.
Interventions
PROCEDUREbariatric surgery
bariatric surgery
Sponsors
Radboud University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Pharmacokinetics of doravirine will be investigated before as well as after bariatric surgery and will be compared for each patient
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC of doravirine | 24 hours | area under the curve, doravirine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adverse events | 24 weeks | adverse events |
| HIV viral load | 24 weeks | HIV viral load |
Contacts
Primary ContactLeena Zino
Outcome results
None listed