Recruitment

Recruitment Status
Completed

Inclusion Criterias

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

Exclusion Criterias

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

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

Exclusion Criterias

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

Locations

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

Tracking Information

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