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 (PIBIK study): study protocol for a randomised trial

Table 2 Randomisation strata

Stratum	Baseline Protease-inhibitor Regimen	Use of lipid lowering therapy at study day 1	No of baseline mutations of the NRTI class^a
I	Atazanavir	Yes	< 2
II	Atazanavir	Yes	≥2
III	Atazanavir	No	< 2
IV	Atazanavir	No	≥2
V	Darunavir	Yes	< 2
VI	Darunavir	Yes	≥2
VII	Darunavir	No	< 2
VIII	Darunavir	No	≥2

ISSN: 1471-2334