Top

HPTN 084

Projects

The purpose of this project is 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. 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)

Latest Update:

15 February 2021

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

Research and Policy Briefs

Project Brief: HPTN 084

Stay up to date

Get updates on news, resources, events and happenings from Wits RHI.