Study identification

PURI

https://redirect.ema.europa.eu/resource/46179

EU PAS number

EUPAS42556

Study ID

46179

Official title and acronym

Drug Utilization, Adherence, Effectiveness and Resistance: A Prospective Observational Cohort Study in People living with HIV (PLWH) initiating ARV regimen CAB+RPV LA in Collaboration with EuroSIDA (215161)

DARWIN EU® study

No

Study countries

Albania
Argentina
Austria
Belarus
Belgium
Bosnia and Herzegovina
Croatia
Czechia
Denmark
Estonia
Finland
France
Georgia
Germany
Greece
Hungary
Iceland
Ireland
Israel
Italy
Lithuania
Luxembourg
Netherlands
North Macedonia
Norway
Poland
Portugal
Romania
Russian Federation
Serbia
Slovenia
Spain
Sweden
Switzerland
Ukraine
United Kingdom

Study description

This prospective cohort study will aim to better understand the population receiving CAB and/or RPV LA containing regimens in a real-world clinical setting. The study will assess usage patterns, adherence, clinical effectiveness and monitor for resistance among virologic failures for whom data on resistance testing are available.

Study status

Ongoing
Research institutions and networks

Institutions

ViiV Healthcare
First published:
01/02/2024
Institution

Contact details

GSK Clinical Disclosure Advisor

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

ViiV Healthcare & Janssen
Study protocol
Initial protocol

viiv-215161-protocol-redact

English (1.89 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

EU RMP category 1 (imposed as condition of marketing authorisation)