Patient characteristics, Adherence, and Clinical Outcomes among People Living with HIV (PLWH), Initiating Cabotegravir + Rilpivirine LA Regimen in the OPERA Cohort

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000427
• EU PAS number:
  EUPAS1000000427
• Study ID:
  1000000427
• Official title and acronym:
  Patient characteristics, Adherence, and Clinical Outcomes among People Living with HIV (PLWH), Initiating Cabotegravir + Rilpivirine LA Regimen in the OPERA Cohort
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This is an observational cohort study utilizing prospectively collected electronic health record (EHR) data obtained from the Observational Pharmaco-Epidemiology Research and Analysis (OPERA®) Database to assess the utilization patterns, durability, adherence and discontinuation, virologic effectiveness and safety of Cabotegravir (CAB) + Rilpivirine (RPV) Long Acting (LA) Regimen among adult PLWH. OPERA is a registered trademark of Epividian, Healthcare Analytics and Software firm
• Study status:
  Ongoing

Research institutions and networks

Institutions

ViiV Healthcare

Study timelines

Date when funding contract was signed

Planned: 17/12/2020

Actual: 17/12/2020

Study start date

Planned: 14/06/2021

Actual: 17/08/2021

Date of final study report

Planned: 31/10/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

ViiV Healthcare

Study protocol

Updated protocol

OPERA_CABENUVA Usage and Clinical Outcomes_Protocol Amendment 1 Anonymised 15 Oct 2024.pdf

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable