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 not yet open for participant recruitment.
Verified October 2012 by St Vincent's Hospital, Sydney
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: October 29, 2012
Last verified: October 2012
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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:
- To describe the safety of 28 days of NPEP using co-formulated FTC-RPV-TDF
- To describe the tolerability of 28 days of NPEP using FTC-RPV-TDF
- 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: | November 2012 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 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:
- Man who has sex with men
- Age at least 18 years
- 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
- Able to provide written, informed consent
Able to commit to the study visits
Exclusion Criteria:
- Non-sexual exposure
- Exposure occurring during sex between a man and a woman
- HIV infection diagnosed on day 1 serological testing including indeterminate serology consistent with possible primary HIV infection
- Use of any medication contraindicated with FTC-RPV-TDF
- Serum hepatic transaminase (alanine aminotransferase [ALT] greater than 5 times the upper limit of the normal range
- Serum estimated Glomerular Filtration Rate (eGFR) <60mL/min/ BSAc
- Current therapy for hepatitis B
- Day 1 serological evidence of chronic/active hepatitis B
- Previous NPEP containing FTC-RPV-TDF
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01715636
Locations
| Australia, New South Wales | |
| St Vincents Hospital | Not yet 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 | Not yet recruiting |
| Sydney, New South Wales, Australia, 2000 | |
| Contact: Anna McNulty, MBBS, MD, FRACP +61 2 93827440 Anna.McNulty@SESIAHS.HEALTH.NSW.GOV.AU | |
| Contact: Phillip Read, MBBS, MD, FRACP +61 2 93827440 Phillip.Read@SESIAHS.HEALTH.NSW.GOV.AU | |
| Principal Investigator: Anna McNulty, MBBS, MD, FRACP | |
| Sub-Investigator: Phillip Read, MBBS, MD, FRACP | |
| Australia, Victoria | |
| The Alfred Hospital | Not yet 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 | Not yet 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: | October 29, 2012 |
| 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 March 14, 2013
