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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by St Vincent's Hospital, Sydney
Sponsor:
Information provided by (Responsible Party):
Andrew Carr, St Vincent's Hospital
ClinicalTrials.gov Identifier:
NCT01715636
First received: October 18, 2012
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

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

Condition Intervention Phase
HIV Nonoccupational Post-exposure Prophylaxis in Men Who Have Sex With Men
Drug: Eviplera = emtricitabine 200mg, rilpivirine 25mg, tenofovir 245mg
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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)

Resource links provided by NLM:


Further study details as provided by St Vincent's Hospital, Sydney:

Primary Outcome Measures:
  • To describe the safety of 28 days of nonoccupational post-exposure prophylaxis with Eviplera [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • To describe the tolerability of 28 days of nonoccupational post-exposure prophylaxis with Eviplera [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Subjective reporting of AEs with data collection/grading utilising DAIDS-AE


Other Outcome Measures:
  • on-drug adherence and regimen completion dates [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Eviplera

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01715636

Locations
Australia, New South Wales
St Vincents Hospital Recruiting
Sydney, New South Wales, Australia, 2010
Contact: Robyn A Richardson, RN    +61 2 8382 3872    rrichardson1@stvincents.com.au   
Contact: John Mcallister, RN, M Sc Med    +61 2 8382 2576    jmcallister@stvincents.com.au   
Principal Investigator: Andrew Carr, MBBS, MD, FRACP         
Sub-Investigator: John McAllister, RN, M Sc Med         
Sydney Sexual Heatlh Centre Recruiting
Sydney, New South Wales, Australia, 2000
Contact: Anna McNulty, MBBS, MD, FRACP    +61 2 93827440    Anna.McNulty@SESIAHS.HEALTH.NSW.GOV.AU   
Contact: Kelly Oreilly, RN    +61 2 93827440    Kelly.Oreilly@SESIAHS.HEALTH.NSW.GOV.AU   
Principal Investigator: Anna McNulty, MBBS, MD, FRACP         
Australia, Victoria
The Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Jude Armishaw, RN    +61 3 90768487    J.Armishaw@alfred.org.au   
Contact: Anna Pierce, MD    +61 3 90768487    A.Pierce@alfred.org.au   
Principal Investigator: Anna Pierce, MD         
Melbourne Sexual Health Centre Recruiting
Melbourne, Victoria, Australia, 3053
Contact: Julie Silvers, RN    +61 3 9341 6262    researchunit@mshc.org.au   
Principal Investigator: Tim Read, MBBS, MD, FRACP         
Sponsors and Collaborators
Andrew Carr
  More Information

No publications provided

Responsible Party: Andrew Carr, Professor, St Vincent's Hospital
ClinicalTrials.gov Identifier: NCT01715636     History of Changes
Other Study ID Numbers: 1.0 dated 28 May 2012, Carr (IN-AU-264-0119)
Study First Received: October 18, 2012
Last Updated: April 15, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Tenofovir
Tenofovir disoproxil
Emtricitabine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on July 28, 2014