Clinical Trials

MainTitle

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 has been completed
Sponsor
Andrew Carr


Information provided by (Responsible Party)
Andrew Carr, St Vincent's Hospital

ClinicalTrials.gov Identifier
NCT01715636

First received: October 18, 2012
Last updated: January 8, 2015
Last Verified: January 2015
History of Changes
Purpose

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: Intervention Model: Single Group Assignment
Masking: None (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)

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

Primary Outcome Measures

  • 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 Outcome Measures:
  • 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 Outcome Measures:
  • on-drug adherence and regimen completion dates [ Time Frame: 28 days ]

Enrollment: 100
Study Start Date: December 2012
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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 Name: Eviplera
Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes 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:
    1. Non-sexual exposure
    2. Exposure occurring during sex between a man and a woman
    3. HIV infection diagnosed on day 1 serological testing including indeterminate serology consistent with possible primary HIV infection
    4. Use of any medication contraindicated with FTC-RPV-TDF
    5. Serum hepatic transaminase (alanine aminotransferase [ALT] greater than 5 times the upper limit of the normal range
    6. Serum estimated Glomerular Filtration Rate (eGFR) <60mL/min/ BSAc
    7. Current therapy for hepatitis B
    8. Day 1 serological evidence of chronic/active hepatitis B
    9. Previous NPEP containing FTC-RPV-TDF
    10. 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

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

Sponsors and Collaborators

Andrew Carr
More Information

More Information


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: January 8, 2015  

Additional relevant MeSH terms:
Tenofovir
Emtricitabine
Rilpivirine

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.