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
Trial acronym: PIBIK
Description
HIV-positive individuals who have evidence of drug resistant HIV are usually treated with recommended boosted protease inhibitors such as darunavir or atazanavir. However, these protease inhibitors are either associated with increased cardiovascular risk or higher discontinuation rates due to adverse events such as hyperbilirubinaemia and increased risk of chronic kidney diseases. Ageing of HIV-positive individuals makes it imperative to find alternative agents which are active against drug resistant HIV but without any of the adverse events associated with protease inhibitors Bictegravir, a new generation integrase strand transfer inhibitor (INSTI), is not licensed for the use in patients who already have documented evidence of certain resistant mutations.
However it is plausible that bictegravir in combination with tenofovir alafenamide and emtricitabine as the single tablet regimen Biktarvy®, would be effective in individuals harbouring certain drug resistant HIV. This derives from clinical trial evidence of other INSTI and retrospective analysis of resistance data from pooled clinical trial data of Biktarvy®. To test this hypothesis and address any ethical issues as a result of using a Biktarvy® outside of its licenced indication, we have decided to undertake a randomised pilot study initially with an early assessment of efficacy or futility at 24 weeks and if efficacious to continue to 48 weeks.
Study design: A phase IV, open-label, randomised pilot study
Disease area: Virologically suppressed HIV-1 infected adults harbouring drug resistance mutations
Trial status: Closed
Chief Investigator: Dr Collins Iwuji
Sponsor: University of Sussex
Funder: Gilead Sciences, Inc
Start date: Sep 2019
End date: Jun 2021
Recruitment target: 100
Summary of study results: N/A
For further information contact:
E: n.dailey@bsms.ac.uk