Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000545

EU PAS number

EUPAS1000000545

Study ID

1000000545

Official title and acronym

DARWIN EU® - Use of antiretroviral therapies in paediatric patients

DARWIN EU® study

Yes

Study countries

Germany
Norway
Spain
United Kingdom

Study description

Human immunodeficiency viruses (HIV) are retroviruses that can cause acquired immunodeficiency syndrome (AIDS), a condition that leads to progressive failure of the immune system making an individual vulnerable to opportunistic infections and cancers.(1-3)
The optimisation of HIV treatment has been facilitated by a long-term joint collaborative effort between international organizations, academic institutions, innovator and generic manufacturers and other stakeholders, particularly over the last decade.
The WHO PADO initiative for instance marks progress and discusses also pediatric needs. Several FDCs have been authorised for use in pediatric patient in the latest years.
This study is intended to help the assessment of a current request for a pediatric investigation plan (PIP) waiver and future similar requests, submitted under the assumption that studies in pediatrics are not possible as HIV infection is very low in this population and that the treatments needs of such patients are already met by existing medications in first line.
To support this paediatric waiver request, real-world data (RWD) from prescription data from Germany and Spain indicating very low number of children living with HIV in EU countries was submitted. And although there may be very few young patients living with HIV infection in the EU, it is relevant for the PDCO to know more about prevalent cases of HIV in in this population and better understand prescription patterns in various age groups and understand the prevalence of the use of fix-dose combination (FDC) products.
This study will establish the prevalence of HIV infection amongst pediatric patients as well as the prevalence and incidence of antiretroviral therapy within this pediatric population particularly for FDC products, to estimate the current utilisation of some active substances.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Guido van Leeuwen

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
EMA
Study protocol
Initial protocol

DARWIN EU_Protocol_P3-C1-020_Paediatric HIV_V3.pdf

English (758.76 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable