The Tolerability of, and Adherence to, Dolutegravir With Co-formulated Tenofovir-emtricitabine for HIV Non-occupational Post-exposure Prophylaxis
dPEP
2 other identifiers
interventional
100
1 country
5
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
- 3.To describe on-drug adherence and regimen completion rates of 28 days of NPEP using dolutegravir (DTG) with co-formulated emtricitabine-tenofovir (FTC-TDF)
- 4.To describe the safety of 28 days of non-occupational post-exposure prophylaxis (NPEP) using dolutegravir with co-formulated emtricitabine-tenofovir
- 5.receptive anal intercourse with a source known to be HIV-infected; or
- 6.receptive anal intercourse with a source of unknown HIV status; or
- 7.insertive anal intercourse with a source known to be HIV-infected
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Aug 2014
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedFirst Posted
Study publicly available on registry
August 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedMay 27, 2016
May 1, 2016
1.3 years
June 23, 2014
May 25, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with Adverse Events as a Measure of Safety and Tolerability
twelve (12) weeks
Study Arms (1)
dolutegravir 50mg with co-formulated emtricitabine-tenofovir
EXPERIMENTALOne-hundred eligible participants will receive dolutegravir (1 x 50mg tablet) with co-formulated emtricitabine-tenofovir (1 tablet) once daily for 28 days
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Andrew Carrlead
- ViiV Healthcare Australia Pty. Ltdcollaborator
Study Sites (5)
St Vincent's Hospital Centre for Applied Medical Research
Darlinghurst, New South Wales, 2010, Australia
Sydney Sexual Health Centre
Sydney, New South Wales, 2000, Australia
Clinic 16, Royal North Shore Hospital
Sydney, New South Wales, 2065, Australia
Melbourne Sexual Health Centre
Carlton, Victoria, 3053, Australia
Alfred Hospital
Melbourne, Victoria, 3004, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Head Clinical research Program
Study Record Dates
First Submitted
June 23, 2014
First Posted
August 7, 2014
Study Start
August 1, 2014
Primary Completion
November 1, 2015
Study Completion
February 1, 2016
Last Updated
May 27, 2016
Record last verified: 2016-05