Condition category
Infections and Infestations
Date applied
22/07/2011
Date assigned
09/03/2012
Last edited
04/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Post-exposure prophylaxis (PEP) involves taking anti-HIV medications as soon as possible after you may have been exposed to HIV to try to reduce the chance of becoming HIV positive. It is readily available for healthcare workers following occupational HIV exposure (during the performance of their job duties). The current Department of Health guidelines recommend treatment with combination of three drugs for 28 days, which should be started as soon as possible after the exposure, ideally within one hour. Post-exposure prophylaxis following non-occupational exposure to HIV (e.g., sexual contact, sharing of injection drug needles) is increasingly being provided and many countries including the UK have now developed guidelines for its use. However, studies also suggest that PEP is often poorly tolerated, with patients frequently reporting side effects and not completing their treatment. Identifying drug combinations likely to be better tolerated would therefore be extremely useful. The aim of this study is to determine if, when used in combination with tenofovir/emtricitabine, maraviroc is superior to lopinavir/ritonavir with respect to the proportion of patients who complete 28 days of PEP without developing adverse events.

Who can participate?
Patients aged 18 or over receiving PEP following occupational or non-occupational HIV exposure.

What does the study involve?
Participants are randomly allocated to either the control group or the experimental group. The control group receive 28 days’ treatment with tenofovir/emtricitabine (one tablet once daily) and lopinavir/ritonavir (two tablets twice daily). These drugs are the standard combination currently in use in most centers for PEP in the UK. The experimental group receive 28 days’ treatment with tenofovir/emtricitabine (one tablet once daily) and maraviroc (one tablet twice daily). Participants attend a follow-up visit 3 months after the last dose of medication.

What are the possible benefits and risks of participating?
Collecting blood samples could cause discomfort and may leave temporary bruises. Every effort will be made to minimise this. No additional blood samples will be required in this study beyond the routine care. Maraviroc and lopinavir/ritonavir PEP may cause side effects. The most common side effects are gastrointestinal (digestive) symptoms, but these are unlikely to require any action since the treatment is only given for short time. The study doctor will advise patients on the appropriate management of any side effects. Maraviroc has not ever been used as a part of HIV PEP so its effectiveness has not been documented, and any potential risks will be monitored and the study stopped if necessary.

Where is the study run from?
The Mortimer Market Centre, Camden Provider Services, London
The Claude Nicol Unit, Brighton and Sussex University Hospitals NHS Trust, Brighton
The John Hunter Clinic, Chelsea and Westminster NHS Foundation Trust, London
The Lydia Clinic, St Thomas’ Hospital, London

When is the study starting and how long is it expected to run for?
October 2011 to June 2013.

Who is funding the study?
Global Investigator Initiated Research Group, Pfizer

Who is the main contact?
Dr Paul Benn

Trial website

Contact information

Type

Scientific

Primary contact

Dr Paul Benn

ORCID ID

Contact details

Mortimer Market Centre
Off Capper Street
London
WCE 6JB
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MMC001

Study information

Scientific title

Randomised controlled trial of the tolerability and completion of Maraviroc compared to Kaletra® in combination with Truvada® for HIV Post Exposure Prophylaxis

Acronym

MiPEP

Study hypothesis

This trial aims to determine whether maraviroc-based combination antiretroviral therapy (ART) is superior to a lopinavir (LPV) based combination, in terms of the proportion of patients who complete a full post exposure prophylaxis (PEP) course, and to compare clinical events, safety and toxicity between the two groups.

Ethics approval

1 .NRES Committee London - Riverside ref: 11/LO/1333
2. NHS Brighton and Hove

Study design

Multicentre open-label randomised study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

HIV

Intervention

Control arm:
Patients randomised to the control arm will receive 28 days treatment with Truvada® (tenofovir disoproxil - as fumarate, 245 mg, emtricitabine 200 mg), one tablet once daily in addition to Kaletra® (lopinavir 200 mg, ritonavir 50 mg), two tablets twice daily. These drugs are the standard combination currently in use in most centres for PEP in the UK.

Experimental arm:
Patients randomised to the experimental arm will receive 28 days treatment with Truvada® (tenofovir disoproxil -as fumarate- 245 mg, emtricitabine 200 mg), one tablet once daily in addition to maraviroc (300 mg), one tablet twice daily.

Intervention type

Drug

Phase

Phase IV

Drug names

Tenofovir/emtricitabine, maraviroc, lopinavir/ritonavir

Primary outcome measures

1. Composite end point of completion of 28 days of allocated PEP regimen without Grade 3 or 4 clinical or laboratory adverse events
2. Division of AIDS table for Grading the severity of Adult and Paediatric Adverse Events

Secondary outcome measures

1. Completion rates of 28 days of allocated PEP regimen
2. Rates of Grade 1, 2, 3 or 4 clinical adverse events
3. Rates of Grade 1, 2, 3 or 4 laboratory anormalities
4. Rates and causes of regimen modification or discontinuation
5. Number of missed doses of Truvada® over 28 day course of PEP
6. Number of missed doses of Kaletra®or maraviroc over 28 day course of PEP
7. Number of doses of antidiarrhoeal medication taken
8. Number of doses of antiemetic taken
9. Number of days absent from work or college (not including days attending for clinic visits)
10. Number of clinic visits required
11. Rates of HIV seroconversion at month 4 after exposure
12. Proportion of individuals reporting unprotected anal/vaginal intercourse in
12.1. The three months preceeding PEP
12.2. While receiving PEP and
12.3. In the three months post completion of PEP with a potentially sero-discordant partner
13. Number of sexual partners in
13.1. The three month period preceeding PEP
13.2. While receiving PEP
13.3. The three month period following PEP
14. Rates of sexually transmitted infections [gonorrhoea, chlamydia, Lymphogranuloma venereum (LGV), syphilis, hepatitis B and C]

Overall trial start date

01/10/2011

Overall trial end date

01/06/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. 18 years old or older
2. A patient attending one of four genitourinary medicine clinics and for whom PEP is considered appropriate by the clinician according to current guidelines including following occupational or non occupational exposure
3. Willing to provide written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

280

Participant exclusion criteria

1. The baseline human immunodeficiency virus (HIV) test is reactive or positive
2. Currently receiving medication which would reduce the effectiveness of Kaletra® / maraviroc
3. Currently receiving medication where the interaction would result in a dangerously high level of the concomitant drug
4. Pregnant or trying to become pregnant at the time of trial entry
5. The source is known to have multi-drug resistant HIV and therefore more likely to have CXCR 4 tropic virus
6. History of active substance abuse or psychiatric illness that, in the opinion of the investigator, would preclude compliance with the protocol, dosing schedule or assessments
7. Any other active clinically significant condition, or findings during screening medical history or examination, or abnormality on screening laboratory blood tests that would, in the opinion of the investigator, compromise the patient’s safety or outcome in the trial

Recruitment start date

03/12/2011

Recruitment end date

31/05/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Mortimer Market Centre
Camden Provider Services
London
WCE 6JB
United Kingdom

Trial participating centre

The Claude Nicol Unit
Brighton and Sussex University Hospitals NHS Trust
Brighton
-
United Kingdom

Trial participating centre

The John Hunter Clinic
Chelsea and Westminster NHS Foundation Trust
London
-
United Kingdom

Trial participating centre

The Lydia Clinic
St Thomas’ Hospital
London
-
United Kingdom

Sponsor information

Organisation

Central and North West London NHS Foundation Trust (UK)

Sponsor details

c/o Ms Angela Williams
Camden Provider Services
Bedford House
125 - 133 Camden High Street
London
NW1 7JR
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.cnwl.nhs.uk/

Funders

Funder type

Industry

Funder name

Pfizer (UK) ref: WS923309

Alternative name(s)

Pfizer Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes