The Role of Home Packs of HIV PEPSE in High Risk Individuals

• Status: Completed
• Trial end date: 2021-03-16
• Target enrollment: 0
• Participant gender: Male

Summary

The study is looking at a new way to reduce the risk of catching HIV. Post-exposure Prophylaxis for sexual exposure (PEPSE) is where a month of HIV drugs can be given to reduce the chance of getting HIV, after a risk. To improve its use the Investigators want to see whether providing a 5-day course of PEPSE for people to keep at home (HOME PEPSE) will lead to it being taken much quicker than having to get it from sexual health clinics or A&E. The HOME PEPSE packs contain HIV tablets that are used in routine HIV care. However the type of HIV drugs are slightly different to those currently used in PEPSE and the Investigators hope that they will have fewer side effects. HOME PEP consists of Truvada and Maraviroc.

140 gay men who are at high risk of getting HIV will be randomised to one of two groups. Group A will receive HOME PEPSE immediately and group B will receive HOME PEPSE after 48 weeks on the study.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Collaborators: Gilead Sciences; ViiV Healthcare
• Treatments: Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Maraviroc; Tenofovir

Criteria

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:

1. condomless anal sex with a male on >1 occasion within the 90 days prior to randomization

2. bacterial rectal sexually transmitted infection (STI) within the 90 days prior to randomization

3. use of PEPSE in the 12 months prior to randomization following possible exposure to HIV through unprotected anal intercourse (UAI) with a male

Exclusion Criteria:

1. An acute viral illness that could be due to HIV seroconversion

2. Any contraindications to Truvada or maraviroc according to the current SmPC

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.