HIV Once Daily ARV Single Tablet bPI Regimen
Research type
Research Study
Full title
A Phase 3, randomized, active-controlled, open-label study to evaluate switching to a darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) once-daily single- tablet regimen versus continuing the current regimen consisting of a boosted protease inhibitor (bPI) combined with emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in virologically-suppressed, human immunodeficiency virus type 1 (HIV-1) infected subjects
IRAS ID
164208
Contact name
Andrew Ustianowski
Contact email
Sponsor organisation
Janssen Research and Development, Global Clinical Operations
Eudract number
2014-003052-31
Duration of Study in the UK
2 years, 7 months, 31 days
Research summary
Study TMC114IFD3013 is a randomized, active-controlled, open-label, multicenter, Phase 3 study with virologically-suppressed, HIV-1 infected adult participants. Its purpose is to compare the current standard antiretroviral therapy regimen of a boosted Protease Inhibitor (bPI) combined with emtricitabine and tenofovir disoproxil (FTC/TDF) taken separately with a once-daily single-tablet regimen of darunavir/cobicistat/emtracitabine/tenofovir alafenamide (D/C/F/TAF) over a 48-week treatment period.
Participants will be randomized in a 1:1 ratio to one of the treatment groups. There will be a screening visit followed by eight clinic visits over 48 weeks. The study is followed by a treatment extension phase lasting a further 48 weeks in which all participants will be given the option to receive the experimental treatment D/C/F/TAF.
Study assessments include blood and urine testing, physical examination, ECG, vital signs and weight measurement, assessment of adherence to treatment and adverse events. Participants will receive a logbook for recording any missed treatment doses.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
14/WM/1210
Date of REC Opinion
5 Nov 2014
REC opinion
Favourable Opinion