Pre-exposure Option for Reducing HIV in the UK.(PROUD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Medical Research Council
Sponsor:
Information provided by (Responsible Party):
MRC [ycm], Medical Research Council
ClinicalTrials.gov Identifier:
NCT02065986
First received: February 16, 2014
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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!


Condition Intervention Phase
HIV
Drug: Truvada (once daily tablet containing 300mg tenofovir disoproxil (TDF) and 200mg of emtricitabine (FTC)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Pre-exposure Option for Reducing HIV in the UK: an Open-label Randomisation to Immediate or Deferred Daily Truvada for HIV Negative Gay Men.(PROUD)

Resource links provided by NLM:


Further study details as provided by Medical Research Council:

Primary Outcome Measures:
  • Time to accrual of 500 participants and Retention at 12 and 24 months from randomisation [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HIV infections acquired between trial entry and 12 months, and between 12 and 24 months [ Time Frame: 24months ]

Estimated Enrollment: 500
Study Start Date: October 2012
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: Immediate offer of Truvada-PrEP
Immediate offer of Truvada (once daily tablet containing 300mg tenofovir disoproxil (TDF) and 200mg of emtricitabine (FTC)
Drug: Truvada (once daily tablet containing 300mg tenofovir disoproxil (TDF) and 200mg of emtricitabine (FTC)
Arm B: Deferred (12m) offer of Truvada-PrEP
Access to Truvada from 12 months after enrolment
Drug: Truvada (once daily tablet containing 300mg tenofovir disoproxil (TDF) and 200mg of emtricitabine (FTC)

Detailed Description:

Intervention and control groups:

Arm A: Immediate offer of Truvada-PrEP Arm B: Deferred (12m) offer of Truvada-PrEP

Method of randomisation:

Randomisation will be performed centrally using a computer algorithm based on random permuted blocks stratified by site.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Born to male gender, age 18 years or more
  • Previously attended the enrolling clinic on at least one occasion
  • Completed a screen for HIV and STIs
  • HIV negative by a routinely used assay within 4 weeks prior to or on the day of randomisation
  • Reported unprotected anal intercourse (UAI) on more than one occasion within the 90 days prior to randomisation
  • Likely, in the opinion of the volunteer, to have UAI in the next 90 days
  • Willing and able to comply with the visit schedule throughout the follow-up period
  • Willing and able to provide written informed consent

Exclusion Criteria:

  • An acute viral illness that could be due to HIV seroconversion
  • Any contraindications to Truvada according to the current package insert
  • Treatment for hepatitis B infection indicated or ongoing
  • Unlikely, in the opinion of the clinician, to comply with the randomised allocation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02065986

Contacts
Contact: Prof Sheena McCormack +44 (0)20 7670-4708 s.mccormack@ucl.ac.uk

Locations
United Kingdom
MRC Clinical Trials Unit Recruiting
London, United Kingdom, WC2B 6NH
Contact: Prof Sheena McCormack    +44 (0)20 7670-4708    s.mccormack@ucl.ac.uk   
Sponsors and Collaborators
MRC [ycm]
  More Information

No publications provided

Responsible Party: MRC [ycm], Medical Research Council
ClinicalTrials.gov Identifier: NCT02065986     History of Changes
Other Study ID Numbers: 2012-002373-56
Study First Received: February 16, 2014
Last Updated: February 18, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Medical Research Council:
HIV
Prevention
Truvada

Additional relevant MeSH terms:
Tenofovir
Tenofovir disoproxil
Emtricitabine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on August 01, 2014