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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02206555




Registration number
NCT02206555
Ethics application status
Date submitted
28/07/2014
Date registered
1/08/2014
Date last updated
2/12/2019

Titles & IDs
Public title
PrEP Demonstration Project (PRELUDE Study)
Scientific title
Implementation of HIV Preexposure Prophylaxis With Antiretroviral Medications Among People at High Risk for HIV Infection: A Demonstration Project
Secondary ID [1] 0 0
14/098
Secondary ID [2] 0 0
HEPP 1403
Universal Trial Number (UTN)
Trial acronym
PRELUDE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - emtricitabine/tenofovir disoproxil fumarate

Experimental: Treatment group (TRUVADA) - Homosexual men and heterosexual men and women at high risk of HIV infection


Treatment: Drugs: emtricitabine/tenofovir disoproxil fumarate
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to accrual
Timepoint [1] 0 0
Approximately 18 months
Primary outcome [2] 0 0
Seroconversion-free time on PrEP
Timepoint [2] 0 0
Approximately 18 months
Primary outcome [3] 0 0
Time to TRUVADA discontinuation
Timepoint [3] 0 0
Approximately 18 months
Primary outcome [4] 0 0
Prescribed doses taken
Timepoint [4] 0 0
Approximately 18 months
Primary outcome [5] 0 0
Incidents of HIV seroconversion
Timepoint [5] 0 0
Approximately 24 months
Primary outcome [6] 0 0
Incidents of rectal gonorrhea and chlamydia
Timepoint [6] 0 0
Approximately 18 months
Primary outcome [7] 0 0
Serious adverse reactions
Timepoint [7] 0 0
Approximately 18 months
Primary outcome [8] 0 0
Adverse events
Timepoint [8] 0 0
Approximately 18 months

Eligibility
Key inclusion criteria
- HIV negative at enrollment (per algorithm provided in protocol)

- At high and ongoing risk for acquiring HIV infection (per algorithm provided in
protocol)

- Aged 18 years or over

- Resident of NSW (or elsewhere in Australia if they visit NSW with sufficient frequency
to allow participation)

- Medicare eligible (to have Medicare coverage for the standard-of-care services)

- Willing and able to provide informed consent

- Willing and able to take part in all required study procedures

- Proficiency in written and spoken English (necessary to complete attitude, behavioural
and lifestyle surveys)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- HIV-1 infected or has symptoms consistent with acute viral infection (If HIV positive
status is not confirmed by testing, delay starting PrEP for at least one month and
reconfirm negative HIV-1 status).

- Having an estimated creatinine clearance (glomerular filtration rate [GFR]) <60ml/min

- Having or developing clinical symptoms suggestive of lactic acidosis or pronounced
hepatotoxicity (including nausea, vomiting, unusual or unexpected stomach discomfort,
and weakness)

- Concurrently taking a nephrotoxic agent (e.g., high-dose non-steroidal
anti-inflammatory drugs / NSAIDs)

- Allergic to tenofovir disoproxil fumarate and/or emtricitabine (based on self-report
or recorded)

- Concurrently taking prescribed products containing emtricitabine or tenofovir
disoproxil fumarate including ATRIPLA®, COMPLERA®, EMTRIVA, STRIBILD®, VIREAD; other
drugs containing lamivudine; HEPSERA

- Mental health issues, memory loss or other cognitive impairment or intellectual
disability that may compromise participant safety and/or regimen adherence

- Factors or conditions that may compromise a participant's retention in the study
(incarceration, planned relocation or potential absence from NSW for a period of 3
months or longer during the course of the study)

- Unwilling to adhere to any of the required study procedures

- Currently breastfeeding

Note: Safety for infants exposed to TRUVADA during pregnancy is not fully assessed but no
harm has been reported. Therefore, planning to become pregnant or currently being pregnant
is not an exclusion criterion for this study. However, women who are pregnant should learn
about the risks and benefits of TRUVADA to reduce the risk of acquiring HIV during their
pregnancy. Site investigators will review the risks and benefits of TRUVADA and of
potential HIV infection with pregnant women and women who plan to become pregnant.

Study design
Purpose of the study
Prevention
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
14/11/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/12/2017
Sample size
Target
Accrual to date
Final
327
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
RPA Sexual Health - Camperdown
Recruitment hospital [2] 0 0
Holdsworth House Medical Practice - Darlinghurst
Recruitment hospital [3] 0 0
St Vincent's Hospital HIV, Immunology and Infectious Disease Unit - Darlinghurst
Recruitment hospital [4] 0 0
Western Sydney Sexual Health Centre - Parramatta
Recruitment hospital [5] 0 0
Sydney Sexual Health Centre - Sydney
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2150 - Parramatta
Recruitment postcode(s) [4] 0 0
2000 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Kirby Institute
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Significant increases in HIV diagnoses among gay and other homosexually active men, in
Australia and internationally, have been observed since the late 1990s. The levels of high
HIV risk sexual practices among gay men have also increased, particularly unprotected anal
intercourse (UAI). Nationally, over three quarters of the new HIV infections diagnosed
annually are among men who have sex with men (MSM). The proportion of heterosexual men and
women among those diagnosed with HIV annually has also increased in recent years. Despite
successes in some situations, HIV transmission has not been adequately reduced by the
prevention methods available to those at risk, such as education, condoms, and treatment of
sexually transmitted infections (STIs).

The effectiveness of daily oral antiretroviral medications (ARVs) as preexposure prophylaxis
of HIV (PrEP) has now been established by clinical trials in both heterosexual adults and
homosexual men. Whether PrEP confers high rates of protection in real life situations and is
a feasible strategy to implement still requires further investigation. Through its "HIV
prevention strategy 2015: New era," NSW Health committed to consider how to most
appropriately and efficiently implement PrEP in line with evidence. This commitment
translated in the support to this PrEP demonstration project.

This demonstration project is designed to evaluate the off-label provision of daily
combination of tenofovir disoproxil fumarate and emtricitabine (TDF/FTC, known as TRUVADA) as
PrEP to a sample of sero-negative individuals at high risk for HIV infection in clinical
settings in New South Wales. The project will inform policy development regarding primary HIV
prevention with PrEP.

This is an open-label, single-arm treatment evaluation study. All consenting and eligible HIV
negative participants will receive TRUVADA prescribed for daily administration orally. At
each followup visit, the following procedures will be conducted: clinical evaluations/
procedures, laboratory evaluations/ procedures, testing for HIV, STIs, hepatic and renal
function, assessment for adherence to the prescribed medication, side effects, eligibility
for next TRUVADA prescription, and willingness to continue on PrEP.

As a study requirement, participants will be offered a self-administered assessment of
behaviour, lifestyle and attitudes which will be conducted ideally within two and no more
than seven days of the clinic visit in the participant's private space.

Analyses will include: the feasibility of PrEP delivery, adherence to the study medication,
safety and tolerability, the effects of PrEP use on behavior, and statistical analyses of the
risk of HIV seroconversion.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02206555
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Iryna Zablotska, MD, MPH, PhD
Address 0 0
The Kirby Institute for Infection and Immunity in Society
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/ct2/show/NCT02206555