Status:
COMPLETED
The Tolerability of, and Adherence to, Dolutegravir With Co-formulated Tenofovir-emtricitabine for HIV Non-occupational Post-exposure Prophylaxis
Lead Sponsor:
Andrew Carr
Collaborating Sponsors:
ViiV Healthcare Australia Pty. Ltd
Conditions:
Human Immunodeficiency Virus
Eligibility:
MALE
18+ years
Phase:
PHASE4
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 pri...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02211690
Start Date
August 1 2014
End Date
February 1 2016
Last Update
May 27 2016
Active Locations (5)
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1
St Vincent's Hospital Centre for Applied Medical Research
Darlinghurst, New South Wales, Australia, 2010
2
Sydney Sexual Health Centre
Sydney, New South Wales, Australia, 2000
3
Clinic 16, Royal North Shore Hospital
Sydney, New South Wales, Australia, 2065
4
Melbourne Sexual Health Centre
Carlton, Victoria, Australia, 3053