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

NCT ID: NCT01715636

Last Updated: 2015-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2014-07-31

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

Conditions

HIV Nonoccupational Post-exposure Prophylaxis in Men Who Have Sex With Men

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Eviplera

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

Group Type: OTHER

Eviplera = emtricitabine 200mg, rilpivirine 25mg, tenofovir 245mg

Intervention Type: DRUG

Interventions

Eviplera = emtricitabine 200mg, rilpivirine 25mg, tenofovir 245mg

Intervention Type: DRUG

Other Intervention Names

Eviplera

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Andrew Carr

OTHER

Sponsor Role: lead

Responsible Party

Andrew Carr

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Sydney Sexual Heatlh Centre

Sydney, New South Wales, Australia

St Vincents Hospital

Sydney, New South Wales, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Melbourne Sexual Health Centre

Melbourne, Victoria, Australia

Countries

Australia

References

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.

Reference Type: DERIVED

PMID: 26123937 (View on PubMed)

Other Identifiers

Carr (IN-AU-264-0119)

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1.0 dated 28 May 2012

Identifier Type: -

Identifier Source: org_study_id