HIV PrEP Priming of Immune Effectors (PREPPIE)

Status:Planned
Phase:Open Label
Principal Investigator(s):Pietro Pala, MD
Objective:Can HIV-specific immunity develop in HIV uninfected humans exposed to HIV whilst receiving antiretroviral pre-exposure prophylaxis (PrEP)? Investigators will investigate this possibility in commercial sex workers in Kampala who will be receiving Truvada PrEP for one year.
Prevention Option(s):PrEP
Study Design:Open label
Arms and Assigned Interventions
DescriptionAll participants receive pre-exposure prophylaxis in the form of a daily tablet containing 300 mg of tenofovir disoproxil fumarate and 200 mg emtricitabine (Truvada®, Gilead) for one year, with an optional extension for 6 months.
Mode of DeliveryTablet
ARMsExperimental
Official Code: NCT02593409
Trial Sponsors: MRC/UVRI Uganda Research Unit on Aids
Start Date
End Date
January 4, 2016
June 4, 2018
Enrollment:220
Age range: 18 Years ↔ any
Population:Cisgender Women