HIV plus bariatric surgery MedDRA version: 20.1 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862 MedDRA version: 21.1 Level: LLT Classification code 10068900 Term: Bariatric surgery System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Pifeltro® (100 mg doravirine)
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Doravirine
Current Sponsor code: doravirine
Concentration unit: mg milligram(s)
Concentration ty
Sponsors
Radboud University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: - HIV-infected - VL suppressed or equal to 18 years - Using DOR for at least 4 weeks prior to BS with VL =65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: 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 DOR - Has significant hypersensitivity or other contraindication to DOR - Creatinine clearance <40 ml/min - Severe liver dysfunction (Diagnosed liver cirrhosis: Child-Pugh C) - Pregnancy or planning to be pregnant during first 6 months post BS.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the pharmacokinetics of Doravirine in patients prior to and after undergoing bariatric surgery;Secondary Objective: 1- To assess the safety of DOR in patients prior to and after undergoing BS 2- To assess the viral response to DOR in patients prior to and after undergoing BS ;Primary end point(s): - Geometric Mean and the 95% classical confidence interval of AUC0-24h, Cmax, C24h and median (range) of tmax for doravirine in HIV patients after bariatric surgery (full pk analysis, pre surgery and week 12 post-surgery analysis) - Geometric Mean and the 95% classical confidence interval of doravirine at Ctrough concentrations at 24+/-4 h from last dose doravirine in patients undergoing bariatric surgery (week 4 and week 24 post bariatric surgery) - The percentage of patients showing a HIV VL >40 copy/ml post bariatric surgery - safety and tolerance of DOR post bariatric surgery;Timepoint(s) of evaluation of this end point: Pharmacokinetics (PK) analysis as follows: 1st PK day (-4-0 week pre-BS) and 2nd PK day (week 12 post-BS), a full pharmacokinetic assessment will take place. Blood samples will be taken at the following time points: t=0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 6, 8, and 24h post ingestion (9 samples). On week 4 and week 24 post-BS: One blood samples will be collected at 24h ± 4h after the last doravirine intake (the end of the dosing interval). Safety, HIV viral load and CD4 count: pre-surgery, week 4, 12 and week 24 post bariatric surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Total weight, body mass index (BMI) and waist circumference will be collected to assess reduction in weight and excess BMI. Overall clinical and laboratory data will be collected and summarized before and after surgery. ;Timepoint(s) of evaluation of this end point: BMI and weight at pre-surgery, week 12 and 24 post bariatric surgery. Clinial and laboratory data at pre-surgery, week 12 and 24 post bariatric surgery. | — |
Countries
Netherlands
Contacts
Public ContactDavid Burger
Radboud University Medical Center
Outcome results
None listed