Completed

NCT Number: NCT01715636

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

St Vincents Hospital, Sydney, New South Wales, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eviplera = emtricitabine 200mg, rilpivirine 25mg, tenofovir 245mg

Drug

Other names: Eviplera

Primary outcomes

To describe the safety of 28 days of nonoccupational post-exposure prophylaxis with Eviplera

Time frame: 28 days

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

Secondary outcomes

To describe the tolerability of 28 days of nonoccupational post-exposure prophylaxis with Eviplera

Time frame: 28 days

Subjective reporting of AEs with data collection/grading utilising DAIDS-AE

Other outcomes

on-drug adherence and regimen completion dates

Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Andrew Carr

Other

Registry information

Official study 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)

Acronym: EPEP

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Oct 29, 2012
Registry last updated: Jan 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.