HIV retro study
Research type
Research Study
Full title
Impact of single tablet regimens on adherence and prescription errors – how big an issue and how relevant in both clinical and economic terms.
IRAS ID
151942
Contact name
Phillip Hay
Contact email
Sponsor organisation
Gilead Sciences International Limited
Research summary
HIV-1 infected adults in Italy, Spain, Portugal and the United Kingdom will take part in the study. Antiretroviral treatment (ART) is used in HIV-1 infected patients. This involves the use of a combination of multiple classes of drugs. In order to achieve a successful treatment rate, adherence is of utmost importance, this association between adherence to ART and therapeutic success has been demonstrated.
The study aims to determine whether Single Tablet Regimens will improve adherence and generate clinical and economic benefits and/or prevent prescription errors.
The study focuses primarily on patient adherence to ART but there is also a sub-study which will review and quantify prescription errors. Whilst all centres will participate in the Adherence component, only centres where such data is available will also be included in the Prescription errors component.
The study is non-interventional and collects retrospective data only.
Information on 700 Single Tablet Regimen subjects and 805 non-Single Tablet Regimen subjects will be collected for the adherence study globally.For the Prescription errors sub-study each centre will aim to include 40 inpatient care episodes of HIV-1 infected patients (hospitalised for a minimum of 48 hours between 1st January 2012 and 29th December 2013 and who received, or should have received an ART regimen during the first 48 hours of the hospital period). For the adherence study in order to be eligible for inclusion, the patient must have been on an ART regimen containing Stribild or one which is recommended by EACS v 7.0 and which was taken once daily for at least 90 days between 1st January 2009 and 31st December 2013.
As the study is a retrospective data collection study, the data collection period will be minimal and participants will not need to undergo any treatments or procedures.
REC name
North of Scotland Research Ethics Committee 2
REC reference
14/NS/1040
Date of REC Opinion
3 Sep 2014
REC opinion
Further Information Favourable Opinion