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

Phase 4

Completed

• Conditions: HIV Nonoccupational Post-exposure Prophylaxis in Men Who Have Sex With Men
• Interventions: Drug: Eviplera = emtricitabine 200mg, rilpivirine 25mg, tenofovir 245mg

• Registration Number: NCT01715636
• Lead Sponsor: Andrew Carr

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-18
• Study First Submitted QC: 2012-10-24
• Study First Posted: 2012-10-29
• Study Start: 2012-12
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-08
• Last Update Posted: 2015-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Eviplera	Eviplera = emtricitabine 200mg, rilpivirine 25mg, tenofovir 245mg	Eviplera = emtricitabine 200mg, rilpivirine 25mg, tenofovir 245mg, one tablet, once daily, taken with food, for 28 days

Primary Outcome Measures

Name	Time	Method
To describe the safety of 28 days of nonoccupational post-exposure prophylaxis with Eviplera	28 days	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

Name	Time	Method
To describe the tolerability of 28 days of nonoccupational post-exposure prophylaxis with Eviplera	28 days	Subjective reporting of AEs with data collection/grading utilising DAIDS-AE

Trial Locations

Locations (4)

Melbourne Sexual Health Centre; 🇦🇺 Melbourne, Victoria, Australia

St Vincents Hospital; 🇦🇺 Sydney, New South Wales, Australia

Sydney Sexual Heatlh Centre; 🇦🇺 Sydney, New South Wales, Australia

The Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia