The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Scientific title
Safety, Tolerability, and Adherence to a Raltegravir-based Antiretroviral Regimen for HIV Non-occupational Postexposure Prophylaxis
Secondary ID [1] 0 0
RAL-NPEP version 1.
Universal Trial Number (UTN)
Trial acronym
RAL-NPEP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Prevention 0 0
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To describe the safety of 28 days of nonoccupational post-exposure prophylaxis containing raltegravir - 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
Timepoint [1] 0 0
28 days on drug with 5 month follow-up
Primary outcome [2] 0 0
To describe the tolerability of 28 days of NPEP containing raltegravir - Subjective reporting of AEs with data collection/grading utilising DAIDS-AE
Timepoint [2] 0 0
28 days on-drug and 5 months follow-up
Primary outcome [3] 0 0
To describe on-drug adherence and regimen completion rates of 28 days of NPEP containing raltegravir - Adherence measurement by self report and pill count at 3 time points during the 28-days of NPEP
Timepoint [3] 0 0
28 days
Secondary outcome [1] 0 0
To describe the context of the risk - Context of risk event described using directed questioning around pre determined variables
Timepoint [1] 0 0
Baseline visit day 1 of NPEP
Secondary outcome [2] 0 0
To investigate whether or not receipt of NPEP decreases, increases or has no impact on future HIV risk taking behaviour - 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.
Timepoint [2] 0 0
Visit 2 (day 3-5 of study), visit 7 (day 82-84 of study) visit 9 (day 166-168 of study)
Secondary outcome [3] 0 0
To describe the effects of raltegravir and truvada on key inflammatory biomarkers - 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.
Timepoint [3] 0 0
Day 1 and day 28 of NPEP

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.
Minimum age
18 Years
Maximum age
70 Years
Gender
Males
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Sydney Sexual Health, Sydney Hospital - Sydney
Recruitment hospital [2] 0 0
St. Vincent's Hospital, 390 Victoria Rd, Darlinghurst - Sydney
Recruitment postcode(s) [1] 0 0
2000 - Sydney
Recruitment postcode(s) [2] 0 0
2010 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Andrew Carr
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Merck Sharp & Dohme Corp.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT01087840
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robert Fielden, RN
Address 0 0
St Vincent's Hospital, Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications