Trial intelligence / Profile preview

EPIC-NSW: Rapid PrEP Expansion in NSW

NCT02870790Phase 3

Key facts

Status: Completed
Start: Mar 2016
Primary completion: Mar 2019
Countries: 1
Sponsor: The Kirby Institute
Modality: Small Molecules

Drugs: emtricitabine + tenofovir disoproxil
Conditions: human immunodeficiency virus infection (HIV)

Overview

Phase 3, open-label, single-arm trial of emtricitabine + tenofovir disoproxil in human immunodeficiency virus infection (HIV), sponsored by The Kirby Institute. Primary endpoints: Incidence of HIV infection per 100 person years among study participants at 24 months and Number of HIV diagnoses among gay and bisexual men notified to the NSW Ministry of Health at 24 months. Started Mar 2016; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

treatment
Daily oral TDF/FTC

Who it enrols

HIV negative adults at high risk of HIV infection, with eGFR >= 60 mL/min.

Endpoints

Primary

Incidence of HIV infection per 100 person years among study participants24 months
Number of HIV diagnoses among gay and bisexual men notified to the NSW Ministry of Health24 months

Secondary

Incidence of STI (gonorrhoea, chlamydia and infectious syphilis) per 100 person years among study participants24 months
Rate of PrEP uptake among high risk GBM in NSW24 months
Overall number of notifications of gonorrhoea, chlamydia and infectious syphilis in NSW24 months
Patterns of PrEP use and medication adherence24 months
Behavioural risk practices among PrEP users24 months

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