NCT02211690

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Andrew Carr · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	dolutegravir 50 mg (one tablet daily)
DRUG	emtricitabine-tenofovir 300/200 mg (one tablet daily)

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-11-01
• Completion: 2016-02-01
• First posted: 2014-08-07
• Last updated: 2016-05-27

Locations

5 sites across 1 country: Australia