The role of Home packs of HIV PEPSE in High Risk Individuals

Phase 1

Conditions: HIV
MedDRA version: 20.0Level: PTClassification code 10020187Term: HIV test negativeSystem Organ Class: 10022891 - Investigations
MedDRA version: 20.1Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2013-004809-24-GB

Lead Sponsor: Guy's & St. Thomas' NHS Foundation Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: 140

Inclusion Criteria

1. Male gender at birth, age =18 years
2. HIV negative by a routinely used assay within 4 weeks prior to or on the day of randomization
3. Willing and able to provide written informed consent
4.And any one of:
a.condomless anal sex with a male on >1 occasion within the 90 days prior to randomization
b.bacterial sexually transmitted infection (STI) within the 90 days prior to randomization
c.use of PEPSE in the 12 months prior to randomization following possible exposure to HIV through unprotected anal intercourse (UAI) with a male.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 140

Exclusion Criteria

1. An acute viral illness that could be due to HIV seroconversion
2. Hypersensitivity to active substance
3. allergic to soy or peanuts
4. concomitant use of antihypertensive agents
5. history of postural hypotension
6. known hepBsAg positive
7. current participation in a HIV PrEP or PEPSE study
8. 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To reduce the time to first dose of PEPSE in those accessing PEPSE following potential sexual exposure to HIV;Secondary Objective: To determine:<br>a.the number of appropriate (sexual risk met the criteria for PEPSE) and inappropriate uptakes (risk did not meet the criteria for PEPSE); <br>b.the number of missed opportunities for PEPSE initiation;<br>c.the safety of HOME PEPSE provision with Truvada?/Maraviroc 600mg OD (Safety Objective) taken for =5 days;<br>d.the safety of HOME PEPSE provision with Truvada?/Maraviroc 600mg OD (Safety Objective) given for a 28 day course;<br>e.the impact of HOME PEPSE availability upon sexual health (incident bacterial STI) HIV and risk-taking behaviour.<br>;Primary end point(s): In those accessing PEPSE, the number of hours from HIV sexual risk exposure to initiating PEPSE over 48 weeks.;Timepoint(s) of evaluation of this end point: Arm A = 48 weeks<br>Arm B = 72 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - the number of appropriate (met BASSH guidelines for sexual risk) times HOME PEPSE is accessed;<br>- the number of inappropriate (did not meet BASSH guidelines for sexual risk) times HOME PEPSE was accessed<br>- the number of missed opportunities for PEPSE i.e. should have taken PEPSE but did not<br>- the number of condomless anal sex acts with individuals of unknown or HIV -positive status in the 3 months preceding week 24 and week 48 visits<br>- HIV incidence and incidence of bacterial STI<br>- Adherence to HOME PEPSE from initiation to first contact with sexual health team;<br>- safety of HOME PEPSE as measured by number, type and severity of adverse events from initiation to first contact with sexual health team<br>- safety of HOME PEPSE taken for 28 days as measured by number, type and severity of adverse events during each HOME PEPSE cycle<br>;Timepoint(s) of evaluation of this end point: Arm A = 48 weeks<br>Arm B = 72 weeks