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.
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

October 18, 2012
April 15, 2014
December 2012
August 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01715636 on ClinicalTrials.gov Archive Site
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
Same as current
on-drug adherence and regimen completion dates [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Same as current
 
Safety, Tolerability,and Adherence to Co-formulated Tenofovir-emtricitabine-rilpivirine Used as HIV Nonoccupational Post-exposure Prophylaxis in Men Who Have Sex With Men.
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
Not Provided
Interventional
Phase 4
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Nonoccupational Post-exposure Prophylaxis in Men Who Have Sex With Men
Drug: Eviplera = emtricitabine 200mg, rilpivirine 25mg, tenofovir 245mg
Other Name: Eviplera
Eviplera
Eviplera = emtricitabine 200mg, rilpivirine 25mg, tenofovir 245mg, one tablet, once daily, taken with food, for 28 days
Intervention: Drug: Eviplera = emtricitabine 200mg, rilpivirine 25mg, tenofovir 245mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
October 2014
August 2014   (final data collection date for primary outcome measure)

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
Male
18 Years and older
Yes
Not Provided
Australia
 
NCT01715636
1.0 dated 28 May 2012, Carr (IN-AU-264-0119)
No
Andrew Carr, St Vincent's Hospital
Andrew Carr
Not Provided
Not Provided
St Vincent's Hospital, Sydney
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP