PANNA-B PK

Information for participants

Purpose

The purpose of this study is to determine how much of certain antiretroviral drugs (doravirine, raltegravir and bictegravir/emtricitabine/tenofovir alafenamide) ends up in breastmilk after oral ingestion.

Background

Women with HIV that use antiretroviral drugs are advised not to breastfeed, because it is unknown how much breastfeeding increases the risk of mother to child transmission of HIV. This risk is probably very low. Because breastfeeding is associated with many benefits, for mother and child, some mothers decide to breatsfeed. But, it is unknown how much of the antiretroviral drugs end up in the breastmilk. If these concentrations are very high, this might lead to toxic effects in the child. If the concentrations are very low, this might lead to development of resistance, if the child inadvertently gets HIV, which impedes the treatment of the child.
To help women in their decision on feeding options, it is necessary to gather information on penetration of antiretroviral drugs in breast milk.

Study procedures

If you take part in the study, you will be examined during 12 hours, sleep at home, return the next day and one week later. U may participate multiple times.
During the examination day a intravenous canula will be inserted in your arm, from which 11 blood samples of 2ml will be drawn. You will also be asked to pump breastmilk with an electric pump 6 times.
You will receive one dose of doravirine (1 tablet), raltegravir (2 tablets) or bictegravir with emtricitabine and tenofovir alafenamide (1 tablet).
Known side effects are: nausea and headache, abnormal dreams and insomnia. Very rare side effect are angio edema (swelling of lips and throat and shortness of breath), osteonecrosis (acute damage to bone tissue) and Steven Johnson syndrome (severe skin rash and fever). Because only one dose is ingested, the risk of developing these side effects is considered very low.
Private rooms for pumping are provided. If you do not own a electric breastpump, one can be borrowed from the hospital.

Figure 1 After inclusion a tube of blood (purple cap) and a portion of breastmilk will be collected, then the subject will receive either one dose of doravirine, raltegravir or bictegravir+emtricitabine+tenofovir alafinamide, after which more blood- and breastmilksamples are collected.

Compensation

For each complete sampling day reimbursement of €300,- is accounted for. Travel expenses will be covered as well.

More information

For more information or registration, please contact us:
[email protected]