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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01087840
Registration number
NCT01087840
Ethics application status
Date submitted
15/03/2010
Date registered
16/03/2010
Date last updated
17/04/2014
Titles & IDs
Public title
Raltegravir Use as Nonoccupational Postexposure Prophylaxis (NPEP) in Men Who Have Sex With Men
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Scientific title
Safety, Tolerability, and Adherence to a Raltegravir-based Antiretroviral Regimen for HIV Non-occupational Postexposure Prophylaxis
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Secondary ID [1]
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RAL-NPEP version 1.
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Universal Trial Number (UTN)
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Trial acronym
RAL-NPEP
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HIV Prevention
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HIV Infections
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Condition category
Condition code
Infection
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Acquired immune deficiency syndrome (AIDS / HIV)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Raltegravir
Experimental: Raltegravir, NPEP - Drug: Raltegravir Tablet 400mg taken orally, twice daily with or without food for 28 days along with Truvada 1 tablet taken orally daily for 28 days.
Arms: Raltegravir/Truvada
Treatment: Drugs: Raltegravir
Drug: Raltegravir tablet 400mg is taken orally, twice daily with or without food for 28 days along with Tenofovir disoproxil fumarate/emtricitabine 300mg/200mg 1 tablet taken orally once daily with or without food for 28 days.
Arms: Raltegravir/Truvada Other Names: Isentress/Truvada
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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To describe the safety of 28 days of nonoccupational post-exposure prophylaxis containing raltegravir
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Assessment method [1]
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Objective AE and SAE data collection/grading utilising DAIDS data collection tool. Measurement of weight and vital signs, electrolytes, urea, creatinine, eGFR, inorganic phosphate, calcium, liver function, glucose, amylase, lipase, creatine kinase, lactate, urinalysis
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Timepoint [1]
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28 days on drug with 5 month follow-up
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Primary outcome [2]
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To describe the tolerability of 28 days of NPEP containing raltegravir
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Assessment method [2]
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Subjective reporting of AEs with data collection/grading utilising DAIDS-AE
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Timepoint [2]
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28 days on-drug and 5 months follow-up
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Primary outcome [3]
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To describe on-drug adherence and regimen completion rates of 28 days of NPEP containing raltegravir
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Assessment method [3]
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Adherence measurement by self report and pill count at 3 time points during the 28-days of NPEP
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Timepoint [3]
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28 days
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Secondary outcome [1]
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To describe the context of the risk
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Assessment method [1]
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Context of risk event described using directed questioning around pre determined variables
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Timepoint [1]
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Baseline visit day 1 of NPEP
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Secondary outcome [2]
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To investigate whether or not receipt of NPEP decreases, increases or has no impact on future HIV risk taking behaviour
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Assessment method [2]
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Baseline data collection of HIV risk behaviour in 6 months preceeding NPEP. Repeat data collection at week 12 and week 24 post NPEP risk event. Data collected utilising assisted completion of HIV related behaviour questionaire.
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Timepoint [2]
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Visit 2 (day 3-5 of study), visit 7 (day 82-84 of study) visit 9 (day 166-168 of study)
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Secondary outcome [3]
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To describe the effects of raltegravir and truvada on key inflammatory biomarkers
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Assessment method [3]
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Measurement of CR-P, D-Dimer, IL-6 on a subset of 50 patients receiving raltegravir/truvada NPEP and a subset of 25 patients receiving truvada alone as NPEP.
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Timepoint [3]
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Day 1 and day 28 of NPEP
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Males
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2012
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Sample size
Target
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Accrual to date
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Final
120
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Sydney Sexual Health, Sydney Hospital - Sydney
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Recruitment hospital [2]
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St. Vincent's Hospital, 390 Victoria Rd, Darlinghurst - Sydney
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Recruitment postcode(s) [1]
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2000 - Sydney
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Recruitment postcode(s) [2]
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2010 - Sydney
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Funding & Sponsors
Primary sponsor type
Other
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Name
Andrew Carr
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Merck Sharp & Dohme LLC
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/study/NCT01087840
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Trial related presentations / publications
McAllister J, Carr A. Should a protease inhibitor be standard of care for HIV postexposure prophylaxis? AIDS. 2011 Mar 13;25(5):721-2. doi: 10.1097/QAD.0b013e32834168bd. No abstract available.
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Public notes
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Contacts
Principal investigator
Name
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Robert Fielden, RN
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Address
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St Vincent's Hospital, Sydney
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01087840
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