PANNA Network

A network of European centres is being set up to collect European pharmacokinetic data in pregnant women. The initiator of this European network is the group of David Burger at the Radboud University Nijmegen Medical Centre, the Netherlands. The PANNA network is powered by NEAT, PENTA, Merck, BMS and CTN (CIHR Canadian HIV trials Network).

Why setting up a European Network?

In the US, a network performing PK studies (amongst other research) in pregnant women is in place: IMPAACT (formerly PACTG). The US population is a different patient population compared to the European population.

The EMEA requires data in the European population as well: “patients entering clinical trials should be reasonably representative of the population that will be later treated by the drug”. In Europe, the demographics of HIV-infected pregnant women (Caucasian females and females born in Sub-Saharan Africa) are different from the US population.

Selection of centres

Recruitment of centres started in 2008. At this moment the network consists of 14 centres in 7 different countries. The centres were selected on:

capability of doing 12h or 24h PK recordings
access to a research unit/clinical ward for in-house PK sampling
research nurse & lab facilities (handling, storage)
large clinical site (>40 deliveries/year)
having a multidisciplinary team (ID specialist, gynaecologists/obstetricians, paediatricians)

Six of the selected centres have participated in the SARA study (The Pharmacokinetics of Saquinavir (Invirase new tablet formulation) 1,000mg + Ritonavir (Norvir) 100mg q 12 in HIV-infected pregnant women) (van der Lugt et al.; Antivir Ther 2009; 14(3):443-450).

In this study 40 women were enrolled over a period of 2.5 years.

On the application page you can apply as a new study centre.

The PANNA network and other antivirals

In the PANNA network the first aim is to study newly developed ARVs of which no or limited PK data during pregnancy are available. However, this network could be used to study other antiviral compounds as well (for example against hepatitis C).