Human Immunodeficiency VirusPhase 4dPEPNCT02211690

The Tolerability of, and Adherence to, Dolutegravir With Co-formulated Tenofovir-emtricitabine for HIV Non-occupational Post-exposure Prophylaxis

A Phase 4 study testing dolutegravir 50 mg (one tablet daily) and emtricitabine-tenofovir 300/200 mg (one tablet daily) in people with Human Immunodeficiency Virus, run by Andrew Carr at 5 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study aims to describe the proportion of participants with non-occupational post-exposure prophylaxis (NPEP) failure, defined as NPEP non-completion (including loss to follow-up) at week 4 or primary HIV infection at week 4 or 12, excluding those participants who should and do cease study drug because: 1. 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: Human Immunodeficiency Virus
What is being tested?: dolutegravir 50 mg (one tablet daily) and emtricitabine-tenofovir 300/200 mg (one tablet daily)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 5 sitesAustralia
Study dates: Aug 2014to Feb 2016
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
Potential HIV exposure following:
receptive anal intercourse with a source known to be HIV-infected; or
receptive anal intercourse with a source of unknown HIV status; or
insertive anal intercourse with a source known to be HIV-infected
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 baseline testing (antibody, Western blot, proviral DNA) including indeterminate serology consistent with possible primary HIV infection
Use of any medication contra-indicated with DTG, FTC or TDF
Use of any medication that effects the concentration of dolutegravir and / or concomitant drug including: oxcarbazepine, phenytoin, phenobarbital, carbamazepine, rifampicin, metformin or St. John's wort (St John's wort can be stopped for the 28-day period of NPEP).
History or presence of allergy to DTG, FTC, TDF or their components

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Alanine aminotransferase (ALT) ≥5 times the upper limit of the reference range or ALT ≥3 times and bilirubin ≥1.5 times the upper limit of the reference range
Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice) or known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
Severe hepatic impairment (Class C) as determined by Child-Pugh classification
Serum estimated Glomerular Filtration Rate (eGFR) <60 mL/min/BSAc
Current therapy for hepatitis B infection
Serological evidence of chronic/active hepatitis B
Previous OPEP/NPEP containing DTG
A participant 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 participant's participation for the full duration of the study
Unable to complete study procedures

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Australia5 sites

Melbourne Sexual Health Centre
Carlton, Victoria, 3053
St Vincent's Hospital Centre for Applied Medical Research
Darlinghurst, New South Wales, 2010
Alfred Hospital
Melbourne, Victoria, 3004
Sydney Sexual Health Centre
Sydney, New South Wales, 2000
Clinic 16, Royal North Shore Hospital
Sydney, New South Wales, 2065

Other trials in Australia

About this study

The participant is found to be HIV-infected (study drugs will be ceased until the genotype of the infecting strain is determined)
The source is found to be HIV-uninfected

The primary study objectives are:

To describe on-drug adherence and regimen completion rates of 28 days of NPEP using dolutegravir (DTG) with co-formulated emtricitabine-tenofovir (FTC-TDF)
To describe the safety of 28 days of non-occupational post-exposure prophylaxis (NPEP) using dolutegravir with co-formulated emtricitabine-tenofovir

The study is a multi-site, prospective, open-label, non-randomized trial. One-hundred (100) eligible participants will receive dolutegravir (one tablet) with co-formulated emtricitabine-tenofovir, two tablets, once daily for 28 days based on one of the following exposures:

receptive anal intercourse with a source known to be HIV-infected; or
receptive anal intercourse with a source of unknown HIV status; or
insertive anal intercourse with a source known to be HIV-infected

There will be 7 study visits over a 12-week period. Follow-up post NPEP is for 8 weeks i.e. to week-12 post-exposure. Any participant who is intolerant of dolutegravir will be managed at the investigator's discretion.

Conditions: Human Immunodeficiency Virus
Being tested: dolutegravir 50 mg (one tablet daily), emtricitabine-tenofovir 300/200 mg (one tablet daily)
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

dolutegravir 50 mg (one tablet daily)Drug
emtricitabine-tenofovir 300/200 mg (one tablet daily)Drug

Study groups in NCT02211690
Study group	Role	What they receive
dolutegravir 50mg with co-formulated emtricitabine-tenofovir	Experimental	One-hundred eligible participants will receive dolutegravir (1 x 50mg tablet) with co-formulated emtricitabine-tenofovir (1 tablet) once daily for 28 days Receives: Drug: dolutegravir 50 mg (one tablet daily); Drug: emtricitabine-tenofovir 300/200 mg (one tablet daily)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants with Adverse Events as a Measure of Safety and Tolerability
Measured: twelve (12) weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2014Feb 2016

First posted7 Aug 2014 (estimated)
Study startAug 2014
Primary completionNov 2015
Study completionFeb 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Human Immunodeficiency VirusStudies 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)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02211690
Sponsor's protocol ID: 2.0 dated 23 June 2014
Other IDs: 201047
Acronym: dPEP
Status last verified: May 2016
First submitted: 23 Jun 2014
Last updated: 27 May 2016
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Human Immunodeficiency Virus trials

Study at a glance

From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Tolerability of, and Adherence to, Dolutegravir With Co-formulated Tenofovir-emtricitabine for HIV Non-occupational Post-exposure Prophylaxis
ClinicalTrials.gov ID: NCT02211690
Acronym / sponsor ID: dPEP / 2.0 dated 23 June 2014
Conditions: Human Immunodeficiency Virus
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Andrew CarrUniversity, hospital or other
Collaborators: ViiV Healthcare Australia Pty. Ltd
Study start: Aug 2014
Primary completion: Nov 2015 (actual)
Study completion: Feb 2016 (actual)
First posted: 7 Aug 2014 (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.

The participant is found to be HIV-infected (study drugs will be ceased until the genotype of the infecting strain is determined)
The source is found to be HIV-uninfected

The primary study objectives are:

To describe on-drug adherence and regimen completion rates of 28 days of NPEP using dolutegravir (DTG) with co-formulated emtricitabine-tenofovir (FTC-TDF)
To describe the safety of 28 days of non-occupational post-exposure prophylaxis (NPEP) using dolutegravir with co-formulated emtricitabine-tenofovir

receptive anal intercourse with a source known to be HIV-infected; or
receptive anal intercourse with a source of unknown HIV status; or
insertive anal intercourse with a source known to be HIV-infected

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
dolutegravir 50mg with co-formulated emtricitabine-tenofovir	Experimental	Drug: dolutegravir 50 mg (one tablet daily), Drug: emtricitabine-tenofovir 300/200 mg (one tablet daily)One-hundred eligible participants will receive dolutegravir (1 x 50mg tablet) with co-formulated emtricitabine-tenofovir (1 tablet) once daily 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 (8 listed)

Man who has sex with men
Age at least 18 years
Potential HIV exposure following:
Able to provide written, informed consent
Able to commit to the study visits

Key exclusion criteria (15 listed)

Non-sexual exposure
Exposure occurring during sex between a man and a woman
HIV infection diagnosed on baseline testing (antibody, Western blot, proviral DNA) including indeterminate serology consistent with possible primary HIV infection
Use of any medication contra-indicated with DTG, FTC or TDF
Use of any medication that effects the concentration of dolutegravir and / or concomitant drug including: oxcarbazepine, phenytoin, phenobarbital, carbamazepine, rifampicin, metformin or St. John's wort (St John's wort can be stopped for the 28-day period of NPEP).

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
dolutegravir 50 mg (one tablet daily)	Drug	dolutegravir 50mg with co-formulated emtricitabine-tenofovir
emtricitabine-tenofovir 300/200 mg (one tablet daily)	Drug	dolutegravir 50mg with co-formulated emtricitabine-tenofovir

Primary outcome

Number of participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: twelve (12) weeks

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 27 May 2016.

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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.

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 15 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 27 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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?

Number of participants with Adverse Events as a Measure of Safety and Tolerability (time frame: twelve (12) weeks). 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 NCT02211690.

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 27 May 2016.