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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/NCT02211690




Registration number
NCT02211690
Ethics application status
Date submitted
23/06/2014
Date registered
7/08/2014
Date last updated
27/05/2016

Titles & IDs
Public title
The Tolerability of, and Adherence to, Dolutegravir With Co-formulated Tenofovir-emtricitabine for HIV Non-occupational Post-exposure Prophylaxis
Scientific title
The Tolerability of, and Adherence to, Dolutegravir With Co-formulated Tenofovir-emtricitabine for HIV Non-occupational Post-exposure Prophylaxis
Secondary ID [1] 0 0
201047
Secondary ID [2] 0 0
2.0 dated 23 June 2014
Universal Trial Number (UTN)
Trial acronym
dPEP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Human Immunodeficiency Virus 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 - dolutegravir 50 mg (one tablet daily)
Treatment: Drugs - emtricitabine-tenofovir 300/200 mg (one tablet daily)

Experimental: dolutegravir 50mg with co-formulated emtricitabine-tenofovir - One-hundred eligible participants will receive dolutegravir (1 x 50mg tablet) with co-formulated emtricitabine-tenofovir (1 tablet) once daily for 28 days


Treatment: Drugs: dolutegravir 50 mg (one tablet daily)


Treatment: Drugs: emtricitabine-tenofovir 300/200 mg (one tablet daily)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with Adverse Events as a Measure of Safety and Tolerability
Timepoint [1] 0 0
twelve (12) weeks

Eligibility
Key inclusion criteria
1. Man who has sex with men

2. Age at least 18 years

3. Potential HIV exposure following:

- receptive anal intercourse with a source known to be HIV-infected; or

- receptive anal intercourse with a source of unknown HIV status; or

- insertive anal intercourse with a source known to be HIV-infected

4. Able to provide written, informed consent

5. Able to commit to the study visits
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Non-sexual exposure

2. Exposure occurring during sex between a man and a woman

3. HIV infection diagnosed on baseline testing (antibody, Western blot, proviral DNA)
including indeterminate serology consistent with possible primary HIV infection

4. Use of any medication contra-indicated with DTG, FTC or TDF

5. Use of any medication that effects the concentration of dolutegravir and / or
concomitant drug including: oxcarbazepine, phenytoin, phenobarbital, carbamazepine,
rifampicin, metformin or St. John's wort (St John's wort can be stopped for the 28-day
period of NPEP).

6. History or presence of allergy to DTG, FTC, TDF or their components

7. Alanine aminotransferase (ALT) =5 times the upper limit of the reference range or ALT
=3 times and bilirubin =1.5 times the upper limit of the reference range

8. Unstable liver disease (as defined by the presence of ascites, encephalopathy,
coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent
jaundice) or known biliary abnormalities (with the exception of Gilbert's syndrome or
asymptomatic gallstones)

9. Severe hepatic impairment (Class C) as determined by Child-Pugh classification

10. Serum estimated Glomerular Filtration Rate (eGFR) <60 mL/min/BSAc

11. Current therapy for hepatitis B infection

12. Serological evidence of chronic/active hepatitis B

13. Previous OPEP/NPEP containing DTG

14. A participant 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 participant's participation for the full duration of the
study

15. Unable to complete study procedures

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
1/08/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2016
Sample size
Target
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital Centre for Applied Medical Research - Darlinghurst
Recruitment hospital [2] 0 0
Sydney Sexual Health Centre - Sydney
Recruitment hospital [3] 0 0
Clinic 16, Royal North Shore Hospital - Sydney
Recruitment hospital [4] 0 0
Melbourne Sexual Health Centre - Carlton
Recruitment hospital [5] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2000 - Sydney
Recruitment postcode(s) [3] 0 0
2065 - Sydney
Recruitment postcode(s) [4] 0 0
3053 - Carlton
Recruitment postcode(s) [5] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Andrew Carr
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
ViiV Healthcare Australia Pty. Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study aims to describe the proportion of participants with non-occupational
post-exposure prophylaxis (NPEP) failure, defined as NPEP non-completion (including loss to
follow-up) at week 4 or primary HIV infection at week 4 or 12, excluding those participants
who should and do cease study drug because:

1. The participant is found to be HIV-infected (study drugs will be ceased until the
genotype of the infecting strain is determined)

2. The source is found to be HIV-uninfected

The primary study objectives are:

1. To describe on-drug adherence and regimen completion rates of 28 days of NPEP using
dolutegravir (DTG) with co-formulated emtricitabine-tenofovir (FTC-TDF)

2. To describe the safety of 28 days of non-occupational post-exposure prophylaxis (NPEP)
using dolutegravir with co-formulated emtricitabine-tenofovir

The study is a multi-site, prospective, open-label, non-randomized trial. One-hundred (100)
eligible participants will receive dolutegravir (one tablet) with co-formulated
emtricitabine-tenofovir, two tablets, once daily for 28 days based on one of the following
exposures:

1. receptive anal intercourse with a source known to be HIV-infected; or

2. receptive anal intercourse with a source of unknown HIV status; or

3. insertive anal intercourse with a source known to be HIV-infected

There will be 7 study visits over a 12-week period. Follow-up post NPEP is for 8 weeks i.e.
to week-12 post-exposure. Any participant who is intolerant of dolutegravir will be managed
at the investigator's discretion.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02211690
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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/NCT02211690