Safety, Tolerability,and Adherence to Co-formulated Tenofovir-emtricitabine-rilpivirine Used as HIV Nonoccupational Post-exposure Prophylaxis in Men Who Have Sex With Men. - Full Text View

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:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Emtricitabine Tenofovir Tenofovir Disoproxil Fumarate Rilpivirine Eviplera

U.S. FDA Resources

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 ]


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
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 (Adult, Senior)
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

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

Sponsors and Collaborators

Andrew Carr

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


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
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration Australia: Human Research Ethics Committee

Additional relevant MeSH terms:


Tenofovir Emtricitabine Rilpivirine Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors	Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents

ClinicalTrials.gov processed this record on September 30, 2016

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)