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

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

Study Overview

• Status: Completed
• Conditions: HIV Nonoccupational Post-exposure Prophylaxis in Men Who Have Sex With Men
• Intervention / Treatment: Drug: Eviplera = emtricitabine 200mg, rilpivirine 25mg, tenofovir 245mg

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2010
      • St Vincents Hospital
    • Sydney, New South Wales, Australia, 2000
      • Sydney Sexual Heatlh Centre
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital
    • Melbourne, Victoria, Australia, 3053
      • Melbourne Sexual Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Man who has sex with men
2. Age at least 18 years
3. 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
4. Able to provide written, informed consent

5. Able to commit to the study visits

   Exclusion Criteria:

6. Non-sexual exposure
7. Exposure occurring during sex between a man and a woman
8. HIV infection diagnosed on day 1 serological testing including indeterminate serology consistent with possible primary HIV infection
9. Use of any medication contraindicated with FTC-RPV-TDF
10. Serum hepatic transaminase (alanine aminotransferase [ALT] greater than 5 times the upper limit of the normal range
11. Serum estimated Glomerular Filtration Rate (eGFR) <60mL/min/ BSAc
12. Current therapy for hepatitis B
13. Day 1 serological evidence of chronic/active hepatitis B
14. Previous NPEP containing FTC-RPV-TDF
15. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Eviplera; 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; Other Names: Eviplera

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
on-drug adherence and regimen completion dates	28 days

Collaborators and Investigators

• Sponsor: Andrew Carr

Publications and helpful links

General Publications

• Foster R, McAllister J, Read TR, Pierce AB, Richardson R, McNulty A, Carr A. Single-Tablet Emtricitabine-Rilpivirine-Tenofovir as HIV Postexposure Prophylaxis in Men Who Have Sex With Men. Clin Infect Dis. 2015 Oct 15;61(8):1336-41. doi: 10.1093/cid/civ511. Epub 2015 Jun 29.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: October 18, 2012
• First Submitted That Met QC Criteria: October 24, 2012
• First Posted (Estimate): October 29, 2012

Study Record Updates

• Last Update Posted (Estimate): January 12, 2015
• Last Update Submitted That Met QC Criteria: January 8, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Tenofovir; Emtricitabine; Rilpivirine
• Other Study ID Numbers: 1.0 dated 28 May 2012; Carr (IN-AU-264-0119) (Other Grant/Funding Number: Gilead Sciences Pty Ltd)