HIV
Conditions
Interventions
Administration of one dose of either doravirine (DOR) 100mg, raltegravir (RAL)
1200mg or a combination of tenofovir alafenamide 25mg, emtricitabine 200mg and
bictegravir 50mg (BIC/FTC/TAF).
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • At least 18 years of age at the moment of screening • At least 10 days post partum • At the end of breastfeeding period; subject is able to produce breastmilk at least two times a day and is no longer feeding infant at start of study or willing and able to sustain from breastfeeding during four days after ingestion of study medication • Able and willing to sign an informed consent
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Relevant co-medication or comorbidity that might interfere with drug absorption, distribution, metabolism or excretion • Inability to take drugs according to the instructions (i.e. with food) • Presence of positive HIV screening or HIV RNA • Presence of HBsAg or HBcAg without anti-HBs • Presence of grade III/IV anaemia (i.e. Hb
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma and milk concentration curve are used to calculate milk to plasma ratio. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following pharmacokinetic parameters of ARV in plasma and/or breastmilk will be described: o AUC0-tau (AUC over a dosing interval) estimated using the rectangular method (41). o Peak plasma concentration (Cmax) o Time to Cmax o Concentration at end of dosing interval (Ctrough) o Clearance o Apparent volume of distribution o Half life o Parameter estimation trough compartmental modelling | — |
Countries
Netherlands
Outcome results
None listed