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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01715636
Registration number
NCT01715636
Ethics application status
Date submitted
18/10/2012
Date registered
29/10/2012
Date last updated
12/01/2015
Titles & IDs
Public title
Safety, Tolerability,and Adherence to Co-formulated Tenofovir-emtricitabine-rilpivirine Used as HIV Nonoccupational Post-exposure Prophylaxis in Men Who Have Sex With Men.
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Scientific 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)
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Secondary ID [1]
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Carr (IN-AU-264-0119)
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Secondary ID [2]
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1.0 dated 28 May 2012
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Universal Trial Number (UTN)
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Trial acronym
EPEP
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HIV Nonoccupational Post-exposure Prophylaxis in Men Who Have Sex With Men
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other: Eviplera - Eviplera = emtricitabine 200mg, rilpivirine 25mg, tenofovir 245mg, one tablet, once daily, taken with food, for 28 days
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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To describe the safety of 28 days of nonoccupational post-exposure prophylaxis with Eviplera
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Assessment method [1]
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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
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Timepoint [1]
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28 days
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Secondary outcome [1]
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To describe the tolerability of 28 days of nonoccupational post-exposure prophylaxis with Eviplera
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Assessment method [1]
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Subjective reporting of AEs with data collection/grading utilising DAIDS-AE
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Timepoint [1]
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28 days
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
Yes
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Key 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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2014
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Sample size
Target
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Accrual to date
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Final
100
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Sydney Sexual Heatlh Centre - Sydney
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Recruitment hospital [2]
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St Vincents Hospital - Sydney
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Recruitment hospital [3]
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The Alfred Hospital - Melbourne
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Recruitment hospital [4]
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Melbourne Sexual Health Centre - Melbourne
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Recruitment postcode(s) [1]
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2000 - Sydney
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Recruitment postcode(s) [2]
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2010 - Sydney
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Recruitment postcode(s) [3]
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3004 - Melbourne
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Recruitment postcode(s) [4]
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3053 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Andrew Carr
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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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Trial website
https://clinicaltrials.gov/study/NCT01715636
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Trial related presentations / 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.
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Public notes
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Contacts
Principal investigator
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Address
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01715636
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