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

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.

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Key information

Conditions

Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

St Vincent's Hospital Centre for Applied Medical Research, Darlinghurst, New South Wales, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 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

Treatment and study plan

dolutegravir 50 mg (one tablet daily)

Drug

emtricitabine-tenofovir 300/200 mg (one tablet daily)

Drug

Primary outcomes

Number of participants with Adverse Events as a Measure of Safety and Tolerability

Time frame: twelve (12) weeks

Sponsors and collaborators

Lead sponsor

Andrew Carr

Other

Collaborators

ViiV Healthcare Australia Pty. Ltd

Registry information

Acronym: dPEP

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2016
First posted: Aug 7, 2014
Registry last updated: May 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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