Study identification

PURI

https://redirect.ema.europa.eu/resource/43327

EU PAS number

EUPAS35892

Study ID

43327

Official title and acronym

A Prospective, Longitudinal, Observational Registry of Truvada for HIV -1 Pre-Exposure Prophylaxis (PrEP) of Adults and Adolescents in Europe

DARWIN EU® study

No

Study countries

Belgium
Denmark
France
Germany
Norway
Portugal
Sweden
United Kingdom

Study description

Note: This study was cancelled in agreement with the EMA. GS-EU-276-4487: This study is a prospective, longitudinal, observational, and voluntary participation registry of the real-world usage of Truvada for Pre-Exposure Prophylaxis (PrEP) to prevent Human Immunodeficiency Virus Type 1 (HIV-1) infection in adults and adolescents in Europe. The primary objectives of this study are to: (1) Describe how Truvada for PrEP is prescribed or self-initiated, including the dosing pattern (dose and schedule as daily/intermittent), (2) Characterize the demographics of adults and adolescents who were prescribed or are taking Truvada for PrEP and their HIV risk factors, (3) Characterize the nature and frequency of individual monitoring after initiating Truvada for PrEP, including any available information on adherence, (4) Document any cases of new HIV diagnoses and development of any resistance to Truvada, and selected safety data, and (5) Summarize the characteristics of healthcare professionals (HCPs) who prescribe Truvada for PrEP.

Study status

Finalised
Research institution and networks

Institutions

Gilead Sciences
First published:
12/02/2024
Institution
Pharmaceutical company
Multiple centres: 45 centres are involved in the study

Contact details

Gilead Study Director

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Gilead Sciences
Study protocol
Initial protocol

GS-EU-276-4487-appendix-16.1.1-protocol v1.4_f-redact

English (1.43 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 3 (required)