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

Human Immunodeficiency Virus Clinical Trial

— dPEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02211690
• Other study ID #: 2.0 dated 23 June 2014
• Secondary ID: 201047
• Status: Completed
• Phase: Phase 4
• First received: June 23, 2014
• Last updated: May 25, 2016
• Start date: August 2014
• Est. completion date: February 2016

Study information

• Verified date: May 2016
• Source: St Vincent's Hospital, Sydney
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationAustralia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

Drug:
• dolutegravir 50 mg (one tablet daily)

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

Locations

Country	Name	City	State
Australia	Melbourne Sexual Health Centre	Carlton	Victoria
Australia	St Vincent's Hospital Centre for Applied Medical Research	Darlinghurst	New South Wales
Australia	Alfred Hospital	Melbourne	Victoria
Australia	Clinic 16, Royal North Shore Hospital	Sydney	New South Wales
Australia	Sydney Sexual Health Centre	Sydney	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
Andrew Carr	ViiV Healthcare Australia Pty. Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Adverse Events as a Measure of Safety and Tolerability		twelve (12) weeks	Yes