HIV Nonoccupational Post-exposure Prophylaxis in Men Who Have Sex With MenPhase 4EPEPNCT01715636
Safety, Tolerability,and Adherence to Co-formulated Tenofovir-emtricitabine-rilpivirine Used as HIV Nonoccupational Post-exposure Prophylaxis in Men Who Have Sex With Men.
A Phase 4 study testing Eviplera = emtricitabine 200mg, rilpivirine 25mg, tenofovir 245mg in people with HIV Nonoccupational Post-exposure Prophylaxis in Men Who Have Sex With Men, run by Andrew Carr at 4 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Nonoccupational Post-exposure Prophylaxis in Men Who Have Sex With Men
- What is being tested?
- Eviplera = emtricitabine 200mg, rilpivirine 25mg, tenofovir 245mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesAustralia
- Study dates
- Dec 2012to Jul 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
The Alfred Hospital
Melbourne, Victoria, 3004
Melbourne Sexual Health Centre
Melbourne, Victoria, 3053
Sydney Sexual Heatlh Centre
Sydney, New South Wales, 2000
St Vincents Hospital
Sydney, New South Wales, 2010
About this study
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)
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.
Read more
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
- Being tested
- Eviplera = emtricitabine 200mg, rilpivirine 25mg, tenofovir 245mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eviplera = emtricitabine 200mg, rilpivirine 25mg, tenofovir 245mgDrug
Also called Eviplera
| Study group | Role | What they receive |
|---|---|---|
| Eviplera | Other | Eviplera = emtricitabine 200mg, rilpivirine 25mg, tenofovir 245mg, one tablet, once daily, taken with food, for 28 days Receives: Drug: Eviplera = emtricitabine 200mg, rilpivirine 25mg, tenofovir 245mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days
Secondary outcomes (1)
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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study startDec 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV Nonoccupational Post-exposure Prophylaxis in Men Who Have Sex With MenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrew Carr
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrew Carr, St Vincent's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715636
- Sponsor's protocol ID
- 1.0 dated 28 May 2012
- Other IDs
- Carr (IN-AU-264-0119)
- Acronym
- EPEP
- Status last verified
- Jan 2015
- First submitted
- 18 Oct 2012
- Last updated
- 12 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26123937
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01715636
- Acronym / sponsor ID
- EPEP / 1.0 dated 28 May 2012
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Andrew CarrUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 29 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eviplera | Other | Drug: Eviplera = emtricitabine 200mg, rilpivirine 25mg, tenofovir 245mgEviplera = emtricitabine 200mg, rilpivirine 25mg, tenofovir 245mg, one tablet, once daily, taken with food, for 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eviplera = emtricitabine 200mg, rilpivirine 25mg, tenofovir 245mgAlso: Eviplera | Drug | Eviplera |
Primary outcome
To describe the safety of 28 days of nonoccupational post-exposure prophylaxis with Eviplera
Time frame: 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
1 secondary outcome
To describe the tolerability of 28 days of nonoccupational post-exposure prophylaxis with Eviplera
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2015.
- Derived from this study: PubMed 26123937Foster 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eviplera = emtricitabine 200mg, rilpivirine 25mg, tenofovir 245mg in people with HIV Nonoccupational Post-exposure Prophylaxis in Men Who Have Sex With Men, run by Andrew Carr at 4 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To describe the safety of 28 days of nonoccupational post-exposure prophylaxis with Eviplera (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01715636, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2015.