NCT05896748 - Study to Assess the Effects of Cabotegravir (CAB) and Rilpivirine (RPV) Long-Acting (LA) Injections Following Sub-cutaneous (SC) Administration Compared With Intramuscular (IM) Administration in Adult Participants Living With Human Immunodeficiency Virus (HIV-1) Infection in the FLAIR Study | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

November 8, 2022

Primary Completion Date

September 14, 2023

Study Completion Date

September 14, 2023

Conditions

Human Immunodeficiency Virus Type 1 (HIV-1)

Interventions

DRUG

Cabotegravir - Injectable Suspension (CAB LA)

It is a sterile white to slightly pink suspension containing 200 mg/mL of CAB as free acid for administration by intramuscular (IM) injection. Each vial is for single-dose use containing a withdrawable volume of 2.0 mL, and does not require dilution prior to administration. CAB LA is composed of cabotegravir free acid, polysorbate 20, polyethylene glycol 3350, mannitol, and water for injection.

DRUG

Rilpivirine - Injectable Suspension (RPV LA)

It is a sterile white suspension containing 300 mg/mL of RPV as the free base. The route of administration is by intramuscular (IM) injection. Each vial contains a nominal fill of 2.0 mL, and does not require dilution prior to administration. RPV LA requires refrigeration and must be protected from light. RPV LA is composed of RPV free base, poloxamer 338, sodium dihydrogen phosphate monohydrate, citric acid monohydrate, glucose monohydrate, sodium hydroxide, water for injection.

Trial Locations (30)

4001

GSK Investigational Site, Durban

4052

GSK Investigational Site, Wentworth

9301

GSK Investigational Site, Bloemfontein

15405

GSK Investigational Site, Ferrol

18016

GSK Investigational Site, Granada

28040

GSK Investigational Site, Madrid

28041

GSK Investigational Site, Madrid

28046

GSK Investigational Site, Madrid

28702

GSK Investigational Site, San Sebastián de los Reyes

30003

GSK Investigational Site, Murcia

30120

GSK Investigational Site, Murcia

31201

GSK Investigational Site, Macon

38010

GSK Investigational Site, Santa Cruz de Tenerife

38320

GSK Investigational Site, La Laguna-Tenerife

39008

GSK Investigational Site, Santander

48013

GSK Investigational Site, Bilbao

75246

GSK Investigational Site, Dallas

76104

GSK Investigational Site, Fort Worth

77401

GSK Investigational Site, Bellaire

78705

GSK Investigational Site, Austin

M5G 1K2

GSK Investigational Site, Toronto

540-0006

GSK Investigational Site, Osaka

162-8655

GSK Investigational Site, Tokyo

08025

GSK Investigational Site, Barcelona

08907

GSK Investigational Site, Barcelona

03203

GSK Investigational Site, Elche

07198

GSK Investigational Site, Palma de Mallorca

B9 5SS

GSK Investigational Site, Birmingham

LS1 3EX

GSK Investigational Site, Leeds

E1 1BB

GSK Investigational Site, London