s12879-020-05240-y.pdf (471.21 kB)
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
Version 2 2023-06-07, 08:51
Version 1 2023-06-07, 07:28
journal contribution
posted on 2023-06-07, 08:51 authored by Collins IwujiCollins Iwuji, Duncan Churchill, Stephen BremnerStephen Bremner, Nicky Perry, Ye To, Debbie LambertDebbie Lambert, Chloe Bruce, Laura Waters, Chloe Orkin, Anna Maria GerettiBackground Currently recommended boosted protease-inhibitor (bPI) regimens may be associated with increased risk of cardiovascular or chronic kidney diseases; in addition, boosted regimens are particularly associated with drug-drug interactions. Since both cardiovascular and renal disease, and polypharmacy, are common in ageing people with HIV, there is a need for alternative efficacious regimens. bPI-based regimens are often the treatment of choice for individuals with pre-treatment or treatment-acquired resistance but it is plausible that carefully selected HIV-positive individuals with drug resistance, who are virologically suppressed on their current bPI regimen, could maintain virological efficacy when switched to bictegravir, emtricitabine and tenofovir alafenamide (B/F/TAF) fixed dose combination (FDC). Methods/design A phase IV, investigator-initiated, multicentre, open label pilot, randomised two-arm study to assess the safety and efficacy of switching from bPI regimen to B/F/TAF single tablet regimen in integrase inhibitor-naïve, virologically suppressed adults with HIV-1 infection harbouring drug resistance mutations. Eligible individuals will either continue on their bPI regimen or switch to B/F/TAF FDC. After 24?weeks, all participants in the bPI arm will be switched to B/F/TAF and followed for a further 24?weeks and all participants will be followed for 48?weeks. The primary efficacy endpoint is the proportion of participants with HIV-1 RNA
History
Publication status
- Published
File Version
- Published version
Journal
BMC Infectious DiseasesISSN
1471-2334Publisher
BMCExternal DOI
Issue
1Volume
20Page range
1-12Article number
a524Department affiliated with
- Global Health and Infection Publications
Full text available
- No
Peer reviewed?
- Yes
Legacy Posted Date
2020-07-09First Open Access (FOA) Date
2020-07-21First Compliant Deposit (FCD) Date
2020-07-09Usage metrics
Categories
No categories selectedKeywords
Licence
Exports
RefWorks
BibTeX
Ref. manager
Endnote
DataCite
NLM
DC