Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Paul Benn


Study Location:

Skip to Main Content
English | Cymraeg
Be Part of Research - Trial Details - Tolerability and completion of Maraviroc compared to Kaletra® in combination with Truvada® for HIV Post Exposure Prophylaxis

Tolerability and completion of Maraviroc compared to Kaletra® in combination with Truvada® for HIV Post Exposure Prophylaxis

Not Recruiting

Open to: All Genders

Age: Adult

Medical Conditions

HIV


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

03 Dec 2011 31 May 2013

Publications

2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28369381 results

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.


Patients aged 18 or over receiving PEP following occupational or non-occupational HIV exposure.

You can take part if:



You may not be able to take part if:


1. The baseline human immunodeficiency virus (HIV) test is reactive or positive2. 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 drug4. Pregnant or trying to become pregnant at the time of trial entry5. The source is known to have multi-drug resistant HIV and therefore more likely to have CXCR 4 tropic virus6. History of active substance abuse or psychiatric illness that, in the opinion of the investigator, would preclude compliance with the protocol, dosing schedule or assessments7. 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


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Mortimer Market Centre
    Camden Provider Services
    London
    WCE 6JB

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.

Dr Paul Benn



The study is sponsored by Central and North West London NHS Foundation Trust (UK) and funded by Pfizer (UK) ref: WS923309.




We'd like your feedback

Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.


Is this study information helpful?

What will you do next?

Read full details for Trial ID: ISRCTN63350011
Last updated 13 February 2018

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.