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

NCT04965662 | Completed Phase 4 DMC

• 1 other identifier: JF006-3170
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (1)

• Number of hours from HIV risk exposure to PEPSE

  In those accessing PEPSE, the number of hours from HIV sexual risk exposure to initiating PEPSE over 48 weeks.

  48 weeks

Study Arms (2)

Arm A: Home PEPSE (Immediate)

EXPERIMENTAL

Patients randomised to the immediate arm (ARM A) will receive a 5 day PEPSE 'Home pack' containing Truvada® (tenofovir disoproxil -as fumarate- 245 mg, emtricitabine 200 mg), ONE tablet OD and Maraviroc 300 mg, TWO tablets OD.

Drug: Maraviroc; Drug: Truvada

Arm B: Standard of Care (Deferred)

NO INTERVENTION

Standard of care antiretroviral therapy for PEPSE as per the British Association for Sexual Health and HIV (BASHH) guidelines.

Interventions

Maraviroc DRUG

Maraviroc 300 mg, TWO tablets once daily.

Arm A: Home PEPSE (Immediate)

Truvada DRUG

Truvada one tablet once daily

Also known as: tenofovir disoproxil -as fumarate- 245 mg, emtricitabine 200 mg

Arm A: Home PEPSE (Immediate)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• An acute viral illness that could be due to HIV seroconversion
• Any contraindications to Truvada or maraviroc according to the current SmPC
• allergic to soy or peanuts
• concomitant use of antihypertensive agents
• history of postural hypotension
• known hepBsAg positive
• current participation in a HIV PrEP or PEPSE study
• 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.

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• ViiV Healthcare: collaborator
• Gilead Sciences: collaborator

Study Sites (1)

Guy's & St. Thomas' NHS Foundation Trust

London, Greater London, SE1 9RT, United Kingdom

Location

MeSH Terms

Interventions

Maraviroc; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir; Emtricitabine

Intervention Hierarchy (Ancestors)

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

Study Officials

• Julie M Fox, MD

  Chief Investigator-Guy's & St. Thomas' NHS Foundation Trust

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Individuals at high risk for acquiring HIV will be randomized (1:1) to immediate (ARM A) or deferred (ARM B) Home PEPSE provision (standard of care (SOC)); planned duration of follow-up is 48 weeks for Arm A and 72 weeks for Arm B.

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 16, 2021
• Study Start: January 1, 2018
• Primary Completion: March 16, 2021
• Study Completion: March 16, 2021
• Last Updated: July 22, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)