HIV Nonoccupational Post-exposure Prophylaxis in Men Who Have Sex With Men Clinical Trial
Official title:
Safety, Tolerability, and Adherence to Co-formulated Emtricitabine-rilpivirine-tenofovir Used as HIV Nonoccupational Post Exposure Prophylaxis in Men Who Have Sex With Men (EPEP)
This study aims to describe the safety, tolerability and adherence to the coformulated
anti-HIV drug tenofovir-emtricitabine-rilpivirine (eviplera) when given to men who have sex
with men (MSM) following an actual or potential sexual exposure to HIV. This biomedical
intervention is known as nonoccupational post-exposure prophylaxis (NPEP). Patients receive
NPEP if they meet the criteria outlined in the 2007 National Australian NPEP Guidelines.
Three or two anti-HIV drugs are administered for 28-days depending on the severity of the
the assessed HIV acquisition risk. In this study eviplera would constitute 3-drug NPEP.
Tenofovir-emtricitabine (truvada) a component of eviplera has been used in NPEP at SVH since
2006.
This is a multi site, prospective, open-label, non-randomised trial. Participants will be
MSM who present at the various recruitment sites requesting NPEP. Initially, 50 eligible
participants will be assigned to receive eviplera 25mg once daily taken with food for
28-days according to established Australian guidelines for the use of 3-drug NPEP. There
will be 7 visits over a 12-week period. Follow-up post NPEP is for 8 weeks. If an interim
analysis demonstrates acceptable safety, it is proposed to seek ethics approval to increase
the samples size to 100 patients to gain more accurate information on regimen completion
rate and on-drug adherence.
The primary study objectives are:
1. To describe the safety of 28 days of NPEP using co-formulated FTC-RPV-TDF
2. To describe the tolerability of 28 days of NPEP using FTC-RPV-TDF
3. To describe on-drug adherence and regimen completion rates of 28 days of NPEP using
FTC-RPV-TDF
n/a
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention