This study aims to describe the proportion of participants with non-occupational post-exposure prophylaxis (NPEP) failure, defined as NPEP non-completion (including loss to follow-up) at week 4 or primary HIV infection at week 4 or 12, excluding those participants who should and do cease study drug because: 1. The participant is found to be HIV-infected (study drugs will be ceased until the genotype of the infecting strain is determined) 2. The source is found to be HIV-uninfected The primary study objectives are: 1. To describe on-drug adherence and regimen completion rates of 28 days of NPEP using dolutegravir (DTG) with co-formulated emtricitabine-tenofovir (FTC-TDF) 2. To describe the safety of 28 days of non-occupational post-exposure prophylaxis (NPEP) using dolutegravir with co-formulated emtricitabine-tenofovir The study is a multi-site, prospective, open-label, non-randomized trial. One-hundred (100) eligible participants will receive dolutegravir (one tablet) with co-formulated emtricitabine-tenofovir, two tablets, once daily for 28 days based on one of the following exposures: 1. receptive anal intercourse with a source known to be HIV-infected; or 2. receptive anal intercourse with a source of unknown HIV status; or 3. insertive anal intercourse with a source known to be HIV-infected There will be 7 study visits over a 12-week period. Follow-up post NPEP is for 8 weeks i.e. to week-12 post-exposure. Any participant who is intolerant of dolutegravir will be managed at the investigator's discretion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
100
St Vincent's Hospital Centre for Applied Medical Research
Darlinghurst, New South Wales, Australia
Sydney Sexual Health Centre
Sydney, New South Wales, Australia
Clinic 16, Royal North Shore Hospital
Sydney, New South Wales, Australia
Melbourne Sexual Health Centre
Carlton, Victoria, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Number of participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: twelve (12) weeks
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