A prospective observational cohort study to monitor for hepatotoxicity and regimen discontinuation due to liver related adverse events among People with HIV, initiating Cabotegravir + Rilpivirine regimens (215162)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47333
• EU PAS number:
  EUPAS45568
• Study ID:
  47333
• Official title and acronym:
  A prospective observational cohort study to monitor for hepatotoxicity and regimen discontinuation due to liver related adverse events among People with HIV, initiating Cabotegravir + Rilpivirine regimens (215162)
• 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 monitor for hepatotoxicity and regimen discontinuation due to liver-related adverse events (AEs) following initiation of CAB+RPV regimen in comparison to two DTG based 2 drug regimens (2DR), DTG+RPV and DTG+3TC among PLWH
• Study status:
  Ongoing

Research institutions and networks

Institutions

ViiV Healthcare

Study timelines

Date when funding contract was signed

Planned: 11/12/2020

Actual: 12/12/2020

Study start date

Planned: 01/03/2022

Actual: 18/02/2022

Date of final study report

Planned: 15/06/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Viiv Healthcare

Study protocol

Initial protocol

viiv-215162-protocol-orig-redact.pdf

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)