HPTN 084

A Phase 3 Double Blind Safety and Efficacy Study of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women

Summary

To evaluate the safety and efficacy of the injectable agent, cabotegravir (CAB LA) compared to daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), for pre-exposure prophylaxis (PrEP) in HIV-uninfected women

Primary Objectives

  • Efficacy: To evaluate the relative efficacy of oral CAB/CAB LA (oral run-in and injections, Steps 1 and 2) vs. daily oral TDF/FTC for HIV prevention (Steps 1 and 2).
  • Safety: To evaluate the relative safety of oral CAB/CAB LA (oral run-in and injections, Steps 1 and 2) vs. daily oral TDF/FTC for HIV prevention (Steps 1 and 2).

Study Population

HIV-uninfected women at risk for acquiring HIV, 18 to 45 years old in Sub-Saharan Africa

Investigators

Prof Sinead Delany-Moretlwe,

Dr Keolopile Makgamathe ,

Dr Jon Allagappen,

Dr Carrie-Anne Mathew

Donors/Sponsors

Division of AIDS (DAIDS), United States (US) National Institute of Allergy and Infectious Disease (NIAID), US National Institute of Mental Health (NIMH) and US National Institute of Health (NIH)

Website: http://bit.ly/2skTOa0

Latest Update: 15 February 2021

For more about HPTN 084 please email rhicomms@wrhi.ac.za