Pre-exposure Option for Reducing HIV in the UK.(PROUD)
Status:
Completed
Trial end date:
2016-10-01
Target enrollment:
Participant gender:
Summary
This study is looking at a new way to reduce the risk of catching HIV - Truvada-PrEP.
To find out whether a daily tablet, Truvada, can safely reduce the risk of gay men catching
HIV, we need to do a large trial in which half the men do not receive Truvada for one year.
We do not know if gay men at risk of HIV are interested in taking Truvada, and if they are,
whether they would be willing to wait a year before they can take it. The reason it may not
be safe, is that taking Truvada-PrEP may lead to an increase in risk behaviour. This could
mean there was more chance of catching HIV and other infections.
As well as finding out if a large trial would be possible, this study will looks at other
factors including:
- Whether people using PrEP change the number of partners they have sex with
- Whether people using PrEP change how often they use condoms
- Whether PrEP leads to higher rates of other sexually transmitted infections (STIs).
This information on changes in sexual activity over time is one of the most important aspects
of the study, because we have never collected this before in the UK. This means we don't know
what happens to people's sexual activity without PrEP! In October 2014 an interim analysis of
the PROUD study data showed that pre-exposure prophylaxis (PrEP) was highly protective
against HIV for gay men and other men who have sex with men (MSM) at high risk of infection.
The PROUD Trial Steering Committee announced that participants on the deferred arm of the
study, who had not yet started PrEP, should be offered the opportunity to begin PrEP ahead of
schedule. As a result, we changed the study design and offered all enrolled participants the
opportunity to access PrEP. All study participants will be followed up until study closure in
October 2016
Phase:
Phase 4
Details
Lead Sponsor:
MRC [ycm]
Treatments:
Emtricitabine Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Tenofovir