common.study.topics.clinical

Efficacy of Drugs in HIV Populations

common.study.values.description

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).

common.study.values.location

participant.ui.study.affiliations-map.online-study.header-virtual

participant.ui.study.affiliations-map.online-study.text

participant.ui.study.affiliations-map.legend.locations participant.ui.study.affiliations-map.legend.selected

common.study.values.methods

Pharmaceutical medication involved common.study.methods.has-drugs-yes
Patients and healthy individuals accepted common.study.methods.is-healthy-no

Drug - Cabotegravir tablets

30 mg tablets

Drug - TDF/FTC tablets

300 mg/200 mg fixed-dose combination tablets

Drug - TDF/FTC placebo tablets

Drug - CAB placebo tablets

Drug - CAB LA

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

Drug - Placebo for CAB LA

Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter

participant.views.study.view.additional

participant.views.study.view.scientific-title

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

common.study.values.clinical-trial-id

NCT02720094

participant.views.study.view.id

NbWBoa