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Report for Clinical Trial NCT02720094

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 2b/3 Double Blind Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC), For Pre-Exposure Prophylaxis in HIV-Uninfected Cisgender Men and Transgender Women Who Have Sex With Men

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
MeSH:HIV Infections

6 Interventions

Name: Cabotegravir tablets

Description: 30 mg tablets
Type: Drug
Group Labels: 1

Arm A

Name: TDF/FTC tablets

Description: 300 mg/200 mg fixed-dose combination tablets
Type: Drug
Group Labels: 2

Arm A Arm B

Name: TDF/FTC placebo tablets

Type: Drug
Group Labels: 1

Arm A

Name: CAB placebo tablets

Type: Drug
Group Labels: 1

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 thereafter
Type: Drug
Group Labels: 1

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 thereafter
Type: Drug
Group Labels: 1

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 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 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 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 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 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 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 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 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 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 years after study entry

Description: Based on physical examination

Measure: Changes in weight from baseline

Time: Measured through participant's last study visit, up to 4 years after study entry

Description: 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 entry

Description: 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 entry

Description: 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 entry

Description: 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 entry

Purpose: Prevention

Allocation: Randomized

Parallel Assignment


There are 3 SNPs

SNPs


1 K65R

Incidence of resistance mutations to study products (including but not limited to K65R, M184V/I, Q148R) among seroconverters. --- K65R ---


2 M184V

Incidence of resistance mutations to study products (including but not limited to K65R, M184V/I, Q148R) among seroconverters. --- K65R --- --- M184V ---


3 Q148R

Incidence of resistance mutations to study products (including but not limited to K65R, M184V/I, Q148R) among seroconverters. --- K65R --- --- M184V --- --- Q148R ---



HPO Nodes