Recruitment

Recruitment Status
Completed

Inclusion Criteria

Able to provide written, informed consent
Able to commit to the study visits
receptive anal intercourse with a source known to be HIV-infected; or
...
Able to provide written, informed consent
Able to commit to the study visits
receptive anal intercourse with a source known to be HIV-infected; or
Age at least 18 years
receptive anal intercourse with a source of unknown HIV status; or
insertive anal intercourse with a source known to be HIV-infected
Man who has sex with men

Exclusion Criteria

Unable to complete study procedures
Serological evidence of chronic/active hepatitis B
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)
...
Unable to complete study procedures
Serological evidence of chronic/active hepatitis B
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)
Previous OPEP/NPEP containing DTG
Non-sexual exposure
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
Use of any medication contra-indicated with DTG, FTC or TDF
HIV infection diagnosed on baseline testing (antibody, Western blot, proviral DNA) including indeterminate serology consistent with possible primary HIV infection
Exposure occurring during sex between a man and a woman
Severe hepatic impairment (Class C) as determined by Child-Pugh classification
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
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).
Serum estimated Glomerular Filtration Rate (eGFR) <60 mL/min/BSAc
Current therapy for hepatitis B infection

Summary

Conditions
Human Immunodeficiency Virus
Type
Interventional
Phase
Phase 4
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Inclusion Criteria

Able to provide written, informed consent
Able to commit to the study visits
receptive anal intercourse with a source known to be HIV-infected; or
...
Able to provide written, informed consent
Able to commit to the study visits
receptive anal intercourse with a source known to be HIV-infected; or
Age at least 18 years
receptive anal intercourse with a source of unknown HIV status; or
insertive anal intercourse with a source known to be HIV-infected
Man who has sex with men

Exclusion Criteria

Unable to complete study procedures
Serological evidence of chronic/active hepatitis B
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)
...
Unable to complete study procedures
Serological evidence of chronic/active hepatitis B
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)
Previous OPEP/NPEP containing DTG
Non-sexual exposure
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
Use of any medication contra-indicated with DTG, FTC or TDF
HIV infection diagnosed on baseline testing (antibody, Western blot, proviral DNA) including indeterminate serology consistent with possible primary HIV infection
Exposure occurring during sex between a man and a woman
Severe hepatic impairment (Class C) as determined by Child-Pugh classification
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
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).
Serum estimated Glomerular Filtration Rate (eGFR) <60 mL/min/BSAc
Current therapy for hepatitis B infection

Locations

Darlinghurst, New South Wales, 2010
Sydney, New South Wales, 2065
Sydney, New South Wales, 2000
Melbourne, Victoria, 3004
Carlton, Victoria, 3053
...
Darlinghurst, New South Wales, 2010
Sydney, New South Wales, 2065
Sydney, New South Wales, 2000
Melbourne, Victoria, 3004
Carlton, Victoria, 3053

Tracking Information

NCT #
NCT02211690
Collaborators
ViiV Healthcare Australia Pty. Ltd
Investigators
Not Provided