Short title: HPTN 084
Full title: 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: HPTN 084 will 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.
Site locations: HPTN 084 has 20 sites in 7 countries - Botswana, Kenya, Malawi, South Africa, Swaziland, Uganda and Zimbabwe
Population: HPTN 084 will enroll approximately 3,200 women 18 to 45 years old in sub-Saharan Africa who are at risk for acquiring HIV.
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)