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

Study identification

• 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 institutions and networks

Institutions

Gilead Sciences

Multiple centres: 45 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:31/07/2020

Actual:02/09/2021

Study start date

Planned:23/12/2020

Actual:02/09/2021

Date of final study report

Planned:31/03/2025

Actual:02/09/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Gilead Sciences

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)