HIV Nonoccupational Post-exposure Prophylaxis in Men Who Have Sex With Men Clinical Trial
— EPEPOfficial 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)
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
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | July 2014 |
| Est. primary completion date | July 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility |
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 |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Australia | Melbourne Sexual Health Centre | Melbourne | Victoria |
| Australia | The Alfred Hospital | Melbourne | Victoria |
| Australia | St Vincents Hospital | Sydney | New South Wales |
| Australia | Sydney Sexual Heatlh Centre | Sydney | New South Wales |
| Lead Sponsor | Collaborator |
|---|---|
| Andrew Carr |
Australia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | on-drug adherence and regimen completion dates | 28 days | No | |
| Primary | To describe the safety of 28 days of nonoccupational post-exposure prophylaxis with Eviplera | 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 | 28 days | Yes |
| Secondary | To describe the tolerability of 28 days of nonoccupational post-exposure prophylaxis with Eviplera | Subjective reporting of AEs with data collection/grading utilising DAIDS-AE | 28 days | Yes |