NCT04399551 - A Study Evaluating Implementation Strategies for Cabotegravir (CAB)+ Rilpivirine (RPV) Long-acting (LA) Injectables for Human Immunodeficiency Virus (HIV)-1 Treatment in European Countries | Biotech Hunter

Enrollment

437

Participants

Timeline

Start Date

September 28, 2020

Primary Completion Date

March 7, 2022

Study Completion Date

March 13, 2023

Conditions

HIV Infections

Interventions

DRUG

CAB OLI

CAB will be available as 30 milligrams (mg) tablet. It will be administered as one tablet once daily with food from Day 1 to Month 1.

DRUG

CAB LA

CAB LA 600 mg will be administered as intramuscular (IM) injection.

DRUG

RPV OLI

RPV will be available as 25 mg tablet. It will be administered as one tablet once daily with food from Day 1 to Month 1.

DRUG

RPV LA

RPV LA 900 mg will be administered as IM injection.

OTHER

Continuous Quality Improvement (CQI) calls

CQI will be attended by the enhanced arm (Arm-E). The CQI calls will be conducted to identify problems/challenges, generate plans to address the challenges, and identify how to measure the change that results from the plan.

Trial Locations (18)

1000

GSK Investigational Site, Brussels

1200

GSK Investigational Site, Brussels

2000

GSK Investigational Site, Antwerp

9000

GSK Investigational Site, Ghent

29600

GSK Investigational Site, Marbella

30202

GSK Investigational Site, Cartagena (Murcia)

33075

GSK Investigational Site, Bordeaux

45067

GSK Investigational Site, Orléans

50009

GSK Investigational Site, Zaragoza

54511

GSK Investigational Site, Vandœuvre-lès-Nancy

60596

GSK Investigational Site, Frankfurt am Main

75004

GSK Investigational Site, Paris

75010

GSK Investigational Site, Paris

75018

GSK Investigational Site, Paris

80337

GSK Investigational Site, Munich

1105 AZ

GSK Investigational Site, Amsterdam

3584 CX

GSK Investigational Site, Utrecht

03010

GSK Investigational Site, Alicante