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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by St Vincent's Hospital, Sydney
Sponsor:
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: August 5, 2014
Last verified: August 2014
  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

The primary study objectives are:

  1. To describe on-drug adherence and regimen completion rates of 28 days of NPEP using dolutegravir (DTG) with co-formulated emtricitabine-tenofovir (FTC-TDF)
  2. To describe the safety of 28 days of non-occupational post-exposure prophylaxis (NPEP) using dolutegravir with co-formulated emtricitabine-tenofovir

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:

  1. receptive anal intercourse with a source known to be HIV-infected; or
  2. receptive anal intercourse with a source of unknown HIV status; or
  3. 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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: twelve (12) weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: August 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: January 2016 (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

Ages Eligible for Study:   18 Years and older
Genders 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:

  1. Non-sexual exposure
  2. Exposure occurring during sex between a man and a woman
  3. HIV infection diagnosed on baseline testing (antibody, Western blot, proviral DNA) including indeterminate serology consistent with possible primary HIV infection
  4. Use of any medication contra-indicated with DTG, FTC or TDF
  5. 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).
  6. History or presence of allergy to DTG, FTC, TDF or their components
  7. 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
  8. 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)
  9. Severe hepatic impairment (Class C) as determined by Child-Pugh classification
  10. Serum estimated Glomerular Filtration Rate (eGFR) <60 mL/min/BSAc
  11. Current therapy for hepatitis B infection
  12. Serological evidence of chronic/active hepatitis B
  13. Previous OPEP/NPEP containing DTG
  14. 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
  15. Unable to complete study procedures
  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

Contacts
Contact: Andrew Carr, MBBS,MD,FRACP +61 2 8382 3359 andrew.carr@svha.org.au
Contact: Robyn Richardson, RN +61 2 8382 3872 robyn.richardson@svha.org.au

Locations
Australia, New South Wales
St Vincent's Hospital Centre for Applied Medical Research Recruiting
Darlinghurst, New South Wales, Australia, 2010
Contact: Robyn Richardson, RN    (02) 8382 3872    robyn.richardson@svha.org.au   
Contact: Krista Siefried, RN    (02) 8382 2668    krista.siefried@svha.org.au   
Principal Investigator: Andrew Carr, MBBS,MD,FRACP         
Sydney Sexual Health Centre Recruiting
Sydney, New South Wales, Australia, 2000
Contact: Anna McNulty, MBBS,MD,FRACP    (02) 9382 7440    Anna.McNulty@sesiahs.health.nsw.gov.au   
Australia, Queensland
Cairns Sexual Health Service Recruiting
Cairns, Queensland, Australia, 4870
Contact: Darren Russell, MBBS    (07) 4226 4769    Darren.russell@health.qld.gov.au   
Australia, Victoria
Melbourne Sexual Health Centre Recruiting
Carlton, Victoria, Australia, 3053
Contact: Tim Read, MBBS,MD,FRACP    (03) 9341 6262    TRead@mshc.org.au   
Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Anna Pierce, MD    (03) 9076 6900    A.Pierce@alfred.org.au   
Sponsors and Collaborators
Andrew Carr
ViiV Healthcare Australia Pty. Ltd
  More Information

No publications provided

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: August 5, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Dolutegravir
Emtricitabine
Tenofovir
Tenofovir disoproxil
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Integrase Inhibitors
Integrase Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014