Safety, Tolerability,and Adherence to Co-formulated Tenofovir-emtricitabine-rilpivirine Used as HIV Nonoccupational Post-exposure Prophylaxis in Men Who Have Sex With Men.

Study Overview
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Brief Summary
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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: To describe the safety of 28 days of NPEP using co-formulated FTC-RPV-TDF To describe the tolerability of 28 days of NPEP using FTC-RPV-TDF To describe on-drug adherence and regimen completion rates of 28 days of NPEP using FTC-RPV-TDF

Official Title
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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)

Conditions
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HIV Nonoccupational Post-exposure Prophylaxis in Men Who Have Sex With Men

Intervention / Treatment
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* Drug: Eviplera = emtricitabine 200mg, rilpivirine 25mg, tenofovir 245mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Man who has sex with men Age at least 18 years Eligible for 3-drug NPEP according to Australian guidelines for the use of 3-drug NPEP following an actual or potential sexual exposure to HIV or receptive anal intercourse with an unknown source Able to provide written, informed consent Able to commit to the study visits Exclusion Criteria: Non-sexual exposure Exposure occurring during sex between a man and a woman HIV infection diagnosed on day 1 serological testing including indeterminate serology consistent with possible primary HIV infection Use of any medication contraindicated with FTC-RPV-TDF Serum hepatic transaminase (alanine aminotransferase [ALT] greater than 5 times the upper limit of the normal range Serum estimated Glomerular Filtration Rate (eGFR) <60mL/min/ BSAc Current therapy for hepatitis B Day 1 serological evidence of chronic/active hepatitis B Previous NPEP containing FTC-RPV-TDF A patient with a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study, or interfere with the patient's participation for the full duration of the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Eviplera<br>Eviplera = emtricitabine 200mg, rilpivirine 25mg, tenofovir 245mg, one tablet, once daily, taken with food, for 28 days | Drug: Eviplera = emtricitabine 200mg, rilpivirine 25mg, tenofovir 245mg<br> <br> * Other names: Eviplera;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the safety of 28 days of nonoccupational post-exposure prophylaxis with Eviplera | Objective AE and SAE data collection/grading utilising DAIDS data collection tool. Measurement of weight, electrolytes, urea, creatinine, eGFR, inorganic phosphate, calcium, liver function, glucose, amylase, lipase, creatine kinase, lactate | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the tolerability of 28 days of nonoccupational post-exposure prophylaxis with Eviplera | Subjective reporting of AEs with data collection/grading utilising DAIDS-AE | 28 days |