CAB LA PrEP Cohort: Prospective Cohort Study to Assess Effectiveness and Safety of, and Adherence and Resistance to Cabotegravir for Pre-Exposure Prophylaxis in the United States (217671)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000163
• EU PAS number:
  EUPAS1000000163
• Study ID:
  1000000163
• Official title and acronym:
  CAB LA PrEP Cohort: Prospective Cohort Study to Assess Effectiveness and Safety of, and Adherence and Resistance to Cabotegravir for Pre-Exposure Prophylaxis in the United States (217671)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The study will aim to assess usage patterns, adherence, effectiveness, safety, and resistance among individuals initiating CAB LA for PrEP in real world clinical setting, in the United States.
• Study status:
  Ongoing

Research institutions and networks

Institutions

ViiV Healthcare

Study timelines

Date when funding contract was signed

Actual: 09/07/2021

Study start date

Actual: 26/05/2022

Date of final study report

Planned: 22/05/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

ViiV Healthcare

Study protocol

Initial protocol

CAB_LA_for_PrEP_Prospective_Cohort_Study_in_the_US_Final_Protocol_Anonymised.pdf

Regulatory

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