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

NCT02065986 | Completed Phase 4 DMC

• 1 other identifier: 2012-002373-56
• Study Type: interventional
• Target: 544
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

HIV

Keywords

HIV; Prevention; Truvada

Outcome Measures

Primary Outcomes (1)

• Time to accrual of 500 participants and Retention at 12 and 24 months from randomisation

  2 years

Secondary Outcomes (1)

• HIV infections acquired between trial entry and 12 months, and between 12 and 24 months

  24months

Study Arms (2)

Arm A: Immediate offer of Truvada-PrEP

EXPERIMENTAL

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

OTHER

Access to Truvada from 12 months after enrolment

Drug: Truvada (once daily tablet containing 300mg tenofovir disoproxil (TDF) and 200mg of emtricitabine (FTC)

Interventions

Truvada (once daily tablet containing 300mg tenofovir disoproxil (TDF) and 200mg of emtricitabine (FTC) DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MRC [ycm]: lead

Study Sites (1)

MRC Clinical Trials Unit

London, WC2B 6NH, United Kingdom

Location

Related Publications (3)

• Miltz A, Lampe F, McCormack S, Dunn D, White E, Rodger A, Phillips A, Sherr L, Sullivan AK, Reeves I, Clarke A, Gafos M. Prevalence and correlates of depressive symptoms among gay, bisexual and other men who have sex with men in the PROUD randomised clinical trial of HIV pre-exposure prophylaxis. BMJ Open. 2019 Dec 10;9(12):e031085. doi: 10.1136/bmjopen-2019-031085.

  PMID: 31826890 DERIVED

• Miltz AR, Lampe FC, Bacchus LJ, McCormack S, Dunn D, White E, Rodger A, Phillips AN, Sherr L, Clarke A, McOwan A, Sullivan A, Gafos M. Intimate partner violence, depression, and sexual behaviour among gay, bisexual and other men who have sex with men in the PROUD trial. BMC Public Health. 2019 Apr 25;19(1):431. doi: 10.1186/s12889-019-6757-6.

  PMID: 31023281 DERIVED

• McCormack S, Dunn DT, Desai M, Dolling DI, Gafos M, Gilson R, Sullivan AK, Clarke A, Reeves I, Schembri G, Mackie N, Bowman C, Lacey CJ, Apea V, Brady M, Fox J, Taylor S, Antonucci S, Khoo SH, Rooney J, Nardone A, Fisher M, McOwan A, Phillips AN, Johnson AM, Gazzard B, Gill ON. Pre-exposure prophylaxis to prevent the acquisition of HIV-1 infection (PROUD): effectiveness results from the pilot phase of a pragmatic open-label randomised trial. Lancet. 2016 Jan 2;387(10013):53-60. doi: 10.1016/S0140-6736(15)00056-2. Epub 2015 Sep 9.

  PMID: 26364263 DERIVED

MeSH Terms

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir; Emtricitabine

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Research Council

Study Record Dates

• First Submitted: February 16, 2014
• First Posted: February 19, 2014
• Study Start: October 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: October 1, 2016
• Last Updated: January 5, 2017

Record last verified: 2017-01

Locations

GB (1)