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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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.
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)
Secondary ID [1] 0 0
Carr (IN-AU-264-0119)
Secondary ID [2] 0 0
1.0 dated 28 May 2012
Universal Trial Number (UTN)
Trial acronym
EPEP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Nonoccupational Post-exposure Prophylaxis in Men Who Have Sex With Men 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Eviplera = emtricitabine 200mg, rilpivirine 25mg, tenofovir 245mg

Other: Eviplera - Eviplera = emtricitabine 200mg, rilpivirine 25mg, tenofovir 245mg, one tablet, once daily, taken with food, for 28 days


Treatment: Drugs: Eviplera = emtricitabine 200mg, rilpivirine 25mg, tenofovir 245mg
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To describe the safety of 28 days of nonoccupational post-exposure prophylaxis with Eviplera
Timepoint [1] 0 0
28 days
Secondary outcome [1] 0 0
To describe the tolerability of 28 days of nonoccupational post-exposure prophylaxis with Eviplera
Timepoint [1] 0 0
28 days

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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Prevention
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2014
Sample size
Target
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Sydney Sexual Heatlh Centre - Sydney
Recruitment hospital [2] 0 0
St Vincents Hospital - Sydney
Recruitment hospital [3] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [4] 0 0
Melbourne Sexual Health Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2000 - Sydney
Recruitment postcode(s) [2] 0 0
2010 - Sydney
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
3053 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Andrew Carr
Address
Country

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/ct2/show/NCT01715636
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01715636