PIBIK Study
Research type
Research Study
Full title
A Phase IV, Randomised, Open-Label Pilot Study to Evaluate Switching from Protease-Inhibitor based regimen to Bictegravir/Emtricitabine/Tenofovir Alafenamide Single Tablet Regimen in Integrase Inhibitor-naïve, virologically suppressed HIV-1 infected adults harbouring drug resistance mutations.
IRAS ID
257865
Contact name
Collins Iwuji
Contact email
Sponsor organisation
University of Sussex
Eudract number
2018-004732-30
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
This is a randomised controlled trial where patients who are HIV-positive and on effective antiretroviral treatment containing a protease inhibitor will be randomised to either stay on their current medication or switch to tenofovir alafenamide/emtricitabine/bictegravir (Biktarvy) single tablet regimen. Patients who are potentially eligible for this study must have evidence that the virus is resistance to antiretroviral therapy. As HIV multiplies in the body, the virus sometimes changes form (mutates). Some HIV mutations that develop while a person is taking HIV medicines can lead to drug-resistant strains of HIV. Once drug resistance develops, HIV medicines that previously controlled a person’s HIV are no longer effective. In other words, the HIV medicines can't prevent the drug-resistant HIV from multiplying. Drug resistance can cause HIV treatment to fail. We want to investigate if the new regimen is as effective as a regimen containing a protease inhibitor in controlling the multiplication of HIV virus which harbours resistance.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
19/LO/0905
Date of REC Opinion
28 Jun 2019
REC opinion
Favourable Opinion