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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
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
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
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
Timepoint [3] 0 0
28 days
Secondary outcome [1] 0 0
To describe the context of the risk
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
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
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
Sex
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
Not applicable
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
1/07/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2012
Sample size
Target
Accrual to date
Final
120
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 LLC
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/study/NCT01087840
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.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01087840