Raltegravir Use as Nonoccupational Postexposure Prophylaxis (NPEP) in Men Who Have Sex With Men
Information source: St Vincent's Hospital, Sydney
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Prevention; HIV Infections
Intervention: Raltegravir (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Andrew Carr Official(s) and/or principal investigator(s): Robert Fielden, RN, Principal Investigator, Affiliation: St Vincent's Hospital, Sydney Anna McNulty, MBBS, FAChSHM, Principal Investigator, Affiliation: Sydney Sexual Health, Sydney Hospital Phillip Read, MBBS, FAChSHM, Principal Investigator, Affiliation: Sydney Sexual Health, Sydney Hospital Andrew Carr, MBBS, MD, Principal Investigator, Affiliation: St Vincents Hospital
Summary
The use of anti-HIV drugs following a potential sexual or injecting drug use exposure to HIV
in order to try and prevent an exposure from becoming an infection is common. This is called
nonoccupational postexposure prophylaxis (NPEP). The likelihood of NPEP succeeding is
related to intrinsic qualities of the drugs used which includes at which point in the life
cycle of the HIV virus the drugs work, how strong the drugs are against HIV, and how well
tolerated the drugs are i. e. what side effects they produce. Many people skip doses during
their treatment or abandon their treatment because of side effects. The anti-HIV drug
raltegravir works early in the life cycle of the virus i. e. before it integrates with human
DNA, is potent against HIV and causes few side effects. These qualities make it an obvious
choice for use as a NPEP treatment. In this study 100 HIV negative men will receive
raltegravir along with another HIV drug called truvada (commonly used in NPEP) for 28 days
after a possible sexual exposure to HIV. They will be monitored closely for adverse events,
side effects and for their ability to take the medicine each day for the whole 28 days. The
hypothesis in this study states that raltegravir use in NPEP will be safe, well tolerated
and result in a high treatment completion rate.
Clinical Details
Official title: Safety, Tolerability, and Adherence to a Raltegravir-based Antiretroviral Regimen for HIV Non-occupational Postexposure Prophylaxis
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To describe the safety of 28 days of nonoccupational post-exposure prophylaxis containing raltegravirTo describe the tolerability of 28 days of NPEP containing raltegravir To describe on-drug adherence and regimen completion rates of 28 days of NPEP containing raltegravir
Secondary outcome: To describe the context of the riskTo investigate whether or not receipt of NPEP decreases, increases or has no impact on future HIV risk taking behaviour To describe the effects of raltegravir and truvada on key inflammatory biomarkers
Detailed description:
This is a single site, 72-week, prospective, open-label, non-randomized trial. One hundred
and 50 (150) eligible participants will be assigned to receive RAL 400 mg BID along with
tenofovir disoproxil fumarate/emtricitabine (TVD) 1 tablet once daily (3-drug NPEP) for
28-days or TVD 1 tablet once daily (2-drug NPEP) for 28-days according to established
Australian guidelines for the use of 3 or 2-drug NPEP following a potential or actual sexual
exposure to HIV in men who have sex with men (MSM).1 Based on hospital NPEP data over the
past 2 years, it is anticipated that 100 MSM will receive 3-drug (RAL-TVD) NPEP and 50 will
receive 2-drug (TVD) NPEP. Follow-up post NPEP is for 23 weeks i. e. to week 24 post
exposure.
Primary study objectives:
To describe the safety of 28 days of nonoccupational post-exposure prophylaxis(NPEP)
containing raltegravir (RAL) To describe the tolerability of 28 days of NPEP containing RAL
To describe on-drug adherence and regimen completion rates of 28 days of NPEP containing RAL
Secondary study objectives:
To investigate whether or not receipt of NPEP decreases, increases or has no impact on HIV
risk taking behaviour To describe the effects of RAL and tenofovir disoproxil
fumarate/emtricitabine (TVD) on key inflammatory biomarkers in a subset of the main study
population
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Eligible MSM who, according to Australian NPEP guidelines, or in the opinion of the
investigators, are assessed as eligible for NPEP following a potential or actual
sexual exposure to HIV who present to St. Vincent's Hospital, Sydney.
Exclusion Criteria:
- Non sexual exposures
- Exposures occurring during sex between a man and a woman
- HIV infection diagnosed on baseline serological testing including indeterminate
serology consistent with possible primary HIV infection
- Use of any medication contraindicated with RAL or TVD
- Serum hepatic transaminases (ALT/AST) greater than 5 times the upper limit of normal
- Serum creatinine greater than 2 times the upper limit of normal#
- Therapy with adefovir, tenofovir, emtricitabine, lamivudine, or entecavir for
hepatitis B
- Baseline serological evidence of chronic/active hepatitis B
- Previous NPEP containing RAL in the study period
- A patient with a history or current evidence of any condition, therapy, or laboratory
abnormality, or other circumstance that might confound the results of the study, or
interfere with the patient's participation for the full duration of the study
Locations and Contacts
St. Vincent's Hospital, 390 Victoria Rd, Darlinghurst, Sydney, New South Wales 2010, Australia
Sydney Sexual Health, Sydney Hospital, Sydney, New South Wales 2000, Australia
Additional Information
Starting date: July 2010
Last updated: April 15, 2014
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