SNPMiner Trials: Clinical Trial Report
Report for Clinical Trial NCT02720094
Developed by Shray Alag, 2019.
SNP Clinical Trial Gene
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).
NCT02720094 HIV Infections
6 Interventions
Name: Cabotegravir tablets
Description: 30 mg tabletsType: Drug
Arm A
Name: TDF/FTC tablets
Description: 300 mg/200 mg fixed-dose combination tabletsType: Drug
Arm A Arm B
Name: TDF/FTC placebo tablets
Type: Drug
Arm A
Name: CAB placebo tablets
Type: Drug
Arm 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: Drug
Arm 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: Drug
Arm B
Primary Outcomes
Measure: Number of documented incident HIV infections in Steps 1 and 2
Time: Measured through participant's last study visit, up to 4.5 years after study entry
Measure: Number of Grade 2 or higher clinical and laboratory adverse events
Time: Measured through participant's last study visit, up to 4.5 years after study entry
Secondary Outcomes
Measure: Number of documented incident HIV infections in Step 2
Time: Measured through participant's last study visit, up to 4.5 years after study entry
Measure: Number of documented incident HIV infections in Steps 1, 2, and 3
Time: Measured through participant's last study visit, up to 4.5 years after study entry
Measure: Number of documented incident HIV infections in Step 3
Time: Measured through participant's last study visit, up to 4.5 years after study entry
Measure: Number of documented incident HIV infections in Step 2 and 3
Time: Measured through participant's last study visit, up to 4.5 years after study entry
Measure: Changes from baseline in creatinine and creatinine clearance levels
Time: Measured through participant's last study visit, up to 4.5 years after study entry
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 4.5 years after study entry
Measure: Changes in Z-score from baseline and DXA criteria for osteopenia and osteoporosis
Time: Measured through participant's last study visit, up to 4.5 years after study entry
Measure: Incidence of resistance mutations to study products (including but not limited to K65R, M184V/I, Q148R) among seroconverters
Time: Measured through participant's last study visit, up to 4.5 years after study entry
Purpose: Prevention
Allocation: Randomized
Parallel Assignment
There are 3 SNPs
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 ---
HPO Nodes