Back to resultsThe Tolerability of, and Adherence to, Dolutegravir With Co-formulated Tenofovir-emtricitabine for HIV Non-occupational Post-exposure Prophylaxis (dPEP)
Primary Purpose
Human Immunodeficiency Virus
Status
Completed
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
dolutegravir 50 mg (one tablet daily)
emtricitabine-tenofovir 300/200 mg (one tablet daily)
Sponsored by
About this trial
This is an interventional prevention trial for Human Immunodeficiency Virus
Eligibility Criteria
Inclusion Criteria:
- Man who has sex with men
- Age at least 18 years
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
- Able to provide written, informed consent
- Able to commit to the study visits
Exclusion Criteria:
- Non-sexual exposure
- Exposure occurring during sex between a man and a woman
- HIV infection diagnosed on baseline testing (antibody, Western blot, proviral DNA) including indeterminate serology consistent with possible primary HIV infection
- Use of any medication contra-indicated with DTG, FTC or TDF
- 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).
- History or presence of allergy to DTG, FTC, TDF or their components
- 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
- 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)
- Severe hepatic impairment (Class C) as determined by Child-Pugh classification
- Serum estimated Glomerular Filtration Rate (eGFR) <60 mL/min/BSAc
- Current therapy for hepatitis B infection
- Serological evidence of chronic/active hepatitis B
- Previous OPEP/NPEP containing DTG
- 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
- Unable to complete study procedures
Sites / Locations
- St Vincent's Hospital Centre for Applied Medical Research
- Sydney Sexual Health Centre
- Clinic 16, Royal North Shore Hospital
- Melbourne Sexual Health Centre
- Alfred Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
dolutegravir 50mg with co-formulated emtricitabine-tenofovir
Arm Description
One-hundred eligible participants will receive dolutegravir (1 x 50mg tablet) with co-formulated emtricitabine-tenofovir (1 tablet) once daily for 28 days
Outcomes
Primary Outcome Measures
Number of participants with Adverse Events as a Measure of Safety and Tolerability
Secondary Outcome Measures
Full Information
NCT ID
NCT02211690
First Posted
June 23, 2014
Last Updated
May 25, 2016
Sponsor
Andrew Carr
Collaborators
ViiV Healthcare Australia Pty. Ltd
1. Study Identification
Unique Protocol Identification Number
NCT02211690
Brief Title
The Tolerability of, and Adherence to, Dolutegravir With Co-formulated Tenofovir-emtricitabine for HIV Non-occupational Post-exposure Prophylaxis
Acronym
dPEP
Official Title
The Tolerability of, and Adherence to, Dolutegravir With Co-formulated Tenofovir-emtricitabine for HIV Non-occupational Post-exposure Prophylaxis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Andrew Carr
Collaborators
ViiV Healthcare Australia Pty. Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
The participant is found to be HIV-infected (study drugs will be ceased until the genotype of the infecting strain is determined)
The source is found to be HIV-uninfected
The primary study objectives are:
To describe on-drug adherence and regimen completion rates of 28 days of NPEP using dolutegravir (DTG) with co-formulated emtricitabine-tenofovir (FTC-TDF)
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:
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dolutegravir 50mg with co-formulated emtricitabine-tenofovir
Arm Type
Experimental
Arm Description
One-hundred eligible participants will receive dolutegravir (1 x 50mg tablet) with co-formulated emtricitabine-tenofovir (1 tablet) once daily for 28 days
Intervention Type
Drug
Intervention Name(s)
dolutegravir 50 mg (one tablet daily)
Intervention Type
Drug
Intervention Name(s)
emtricitabine-tenofovir 300/200 mg (one tablet daily)
Primary Outcome Measure Information:
Title
Number of participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
twelve (12) weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Man who has sex with men
Age at least 18 years
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
Able to provide written, informed consent
Able to commit to the study visits
Exclusion Criteria:
Non-sexual exposure
Exposure occurring during sex between a man and a woman
HIV infection diagnosed on baseline testing (antibody, Western blot, proviral DNA) including indeterminate serology consistent with possible primary HIV infection
Use of any medication contra-indicated with DTG, FTC or TDF
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).
History or presence of allergy to DTG, FTC, TDF or their components
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
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)
Severe hepatic impairment (Class C) as determined by Child-Pugh classification
Serum estimated Glomerular Filtration Rate (eGFR) <60 mL/min/BSAc
Current therapy for hepatitis B infection
Serological evidence of chronic/active hepatitis B
Previous OPEP/NPEP containing DTG
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
Unable to complete study procedures
Facility Information:
Facility Name
St Vincent's Hospital Centre for Applied Medical Research
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Sydney Sexual Health Centre
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
Clinic 16, Royal North Shore Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Melbourne Sexual Health Centre
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
The Tolerability of, and Adherence to, Dolutegravir With Co-formulated Tenofovir-emtricitabine for HIV Non-occupational Post-exposure Prophylaxis
We'll reach out to this number within 24 hrs