C2C: COMBINE-2 for Cabotegravir+Rilpivirine LA Regimen - A Prospective Cohort Study to Monitor Effectiveness, Adherence and Resistance (215160)

Study identification

• EU PAS number:
  EUPAS42609
• Study ID:
  49488
• Official title and acronym:
  C2C: COMBINE-2 for Cabotegravir+Rilpivirine LA Regimen - A Prospective Cohort Study to Monitor Effectiveness, Adherence and Resistance (215160)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  France

  Germany

  Italy

  Netherlands

  Spain

  Sweden

  Switzerland

  United Kingdom
• Study description:
  This prospective cohort study will gather real world evidence in routine clinical practice to evaluate the CAB+RPV LA regimen. The study will assess effectiveness, discontinuation, and resistance over 24-months of follow-up period in patients living with HIV.
• Study status:
  Ongoing

Research institutions and networks

Institutions

ViiV Healthcare

Study timelines

Date when funding contract was signed

Planned:02/12/2020

Actual:02/12/2020

Study start date

Planned:13/05/2022

Actual:05/05/2022

Date of final study report

Planned:30/09/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

ViiV Healthcare & Janssen

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)