This study will evaluate the safety and efficacy of the injectable drug cabotegravir (CAB LA), for pre-exposure prophylaxis (PrEP) in HIV-uninfected cisgender men and transgender women who have sex with men (MSM and TGW).
Name: Cabotegravir tablets
Description: 30 mg tabletsType: DrugArm A
Name: TDF/FTC tablets
Description: 300 mg/200 mg fixed-dose combination tabletsType: DrugArm A Arm B
Name: TDF/FTC placebo tablets
Type: DrugArm A
Name: CAB placebo tablets
Type: DrugArm B
Name: CAB LA
Description: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafterType: DrugArm A
Name: Placebo for CAB LA
Description: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafterType: DrugArm B
Description: (laboratory assessment of alanine aminotransferase (ALT), aspartate aminotransferase (AST), TBili, creatine phosphokinase (CPK), or clinical assessment of jaundice/icterus).
Measure: Number of Grade 3 or 4 liver-related adverse events (AEs) Time: Measured through participant's last study visit, up to 4 years after study entryDescription: Based on physical examination
Measure: Changes in weight from baseline Time: Measured through participant's last study visit, up to 4 years after study entryDescription: Based on physical examination
Measure: Changes in blood pressure from baseline Time: Measured through participant's last study visit, up to 4 years after study entryDescription: Based on physical examination
Measure: Changes in pulse rate from baseline Time: Measured through participant's last study visit, up to 4 years after study entryDescription: Based on laboratory evaluations
Measure: Changes in fasting glucose levels from baseline Time: Measured through participant's last study visit, up to 4 years after study entryDescription: Based on laboratory evaluations
Measure: Changes in fasting lipid profile from baseline Time: Measured through participant's last study visit, up to 4 years after study entryAllocation: Randomized
Parallel Assignment
There are 3 SNPs
Incidence of resistance mutations to study products (including but not limited to K65R, M184V/I, Q148R) among seroconverters. --- K65R ---
Incidence of resistance mutations to study products (including but not limited to K65R, M184V/I, Q148R) among seroconverters. --- K65R --- --- M184V ---
Incidence of resistance mutations to study products (including but not limited to K65R, M184V/I, Q148R) among seroconverters. --- K65R --- --- M184V --- --- Q148R ---