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Clinical Trials

MainTitle

The Tolerability of, and Adherence to, Dolutegravir With Co-formulated Tenofovir-emtricitabine for HIV Non-occupational Post-exposure Prophylaxis (dPEP)

This study has been completed
Sponsor
Andrew Carr

Collaborator
ViiV Healthcare Australia Pty. Ltd

Information provided by (Responsible Party)
Andrew Carr, St Vincent's Hospital

ClinicalTrials.gov Identifier
NCT02211690

First received: June 23, 2014
Last updated: May 25, 2016
Last Verified: May 2016
History of Changes
Purpose

Purpose

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. The primary study objectives are:
  4. To describe on-drug adherence and regimen completion rates of 28 days of NPEP using dolutegravir (DTG) with co-formulated emtricitabine-tenofovir (FTC-TDF)
  5. To describe the safety of 28 days of non-occupational post-exposure prophylaxis (NPEP) using dolutegravir with co-formulated emtricitabine-tenofovir


  6. 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:
  7. receptive anal intercourse with a source known to be HIV-infected; or
  8. receptive anal intercourse with a source of unknown HIV status; or
  9. 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.

Condition Intervention Phase
Human Immunodeficiency Virus

Drug : dolutegravir 50 mg (one tablet daily)
Drug : emtricitabine-tenofovir 300/200 mg (one tablet daily)
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Tolerability of, and Adherence to, Dolutegravir With Co-formulated Tenofovir-emtricitabine for HIV Non-occupational Post-exposure Prophylaxis

Further study details as provided by Andrew Carr, St Vincent's Hospital:

Primary Outcome Measures

  • Number of participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: twelve (12) weeks ]

Enrollment: 100
Study Start Date: August 2014
Study Completion Date: February 2016
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: dolutegravir 50mg with co-formulated emtricitabine-tenofovir
One-hundred eligible participants will receive dolutegravir (1 x 50mg tablet) with co-formulated emtricitabine-tenofovir (1 tablet) once daily for 28 days
Drug: dolutegravir 50 mg (one tablet daily)
Drug: emtricitabine-tenofovir 300/200 mg (one tablet daily)
Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: Male  
Accepts Healthy Volunteers: Yes  

Criteria

Inclusion Criteria:

  1. Man who has sex with men
  2. Age at least 18 years
  3. 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
  4. Able to provide written, informed consent
  5. 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

    contacts and locations

    Contacts and Locations

    Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT02211690

    Locations

    Australia
    St Vincent's Hospital Centre for Applied Medical Research
    Darlinghurst, New South Wales, Australia, 2010
    Sydney Sexual Health Centre
    Sydney, New South Wales, Australia, 2000
    Clinic 16, Royal North Shore Hospital
    Sydney, New South Wales, Australia, 2065
    Melbourne Sexual Health Centre
    Carlton, Victoria, Australia, 3053
    Alfred Hospital
    Melbourne, Victoria, Australia, 3004

    Sponsors and Collaborators

    Andrew Carr
    ViiV Healthcare Australia Pty. Ltd
    More Information

    More Information


    Responsible Party: Andrew Carr, Head Clinical research Program, St Vincent's Hospital  
    ClinicalTrials.gov Identifier: NCT02211690   History of Changes  
    Other Study ID Numbers: 2.0 dated 23 June 2014  
      201047  
    Study First Received: June 23, 2014  
    Last Updated: May 25, 2016  

    Additional relevant MeSH terms:
    Immunologic Deficiency Syndromes
    Acquired Immunodeficiency Syndrome
    HIV Infections
    Tenofovir
    Emtricitabine
    Dolutegravir
    Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

    ClinicalTrials.gov processed this data on October 20, 2017
    This information is provided by ClinicalTrials.gov.