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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.
- Source :
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BMC infectious diseases [BMC Infect Dis] 2020 Jul 20; Vol. 20 (1), pp. 524. Date of Electronic Publication: 2020 Jul 20. - Publication Year :
- 2020
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Abstract
- Background: 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).<br />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 < 50 copies/mL at week 24 using pure virologic response whilst the secondary efficacy endpoint is the proportion of participants with HIV-1 RNA < 50 copies/mL at Week 48. Other secondary outcome measures include between arm comparisons of drug resistance at virological failure, safety and tolerability and patient-reported outcome measures.<br />Discussion: We aim to provide preliminary evidence of the efficacy of switching to B/F/TAF in patients with virological suppression on a bPI-based regimen who harbour select drug resistance mutations.<br />Trial Registration: ISRCTN 44453201 , registered 19 June 2019 and EudraCT 2018-004732-30.
- Subjects :
- Adenine therapeutic use
Adult
Alanine
Amides
Drug Combinations
Emtricitabine adverse effects
Female
HIV Infections genetics
HIV Infections virology
HIV Integrase Inhibitors adverse effects
Heterocyclic Compounds, 3-Ring
Heterocyclic Compounds, 4 or More Rings adverse effects
Humans
Male
Mutation
Pilot Projects
Piperazines
Prospective Studies
Protease Inhibitors adverse effects
Pyridones
Reverse Transcriptase Inhibitors adverse effects
Tenofovir analogs & derivatives
Treatment Outcome
Adenine analogs & derivatives
Drug Resistance, Viral genetics
Emtricitabine therapeutic use
HIV Infections drug therapy
HIV Integrase Inhibitors therapeutic use
HIV-1 drug effects
Heterocyclic Compounds, 4 or More Rings therapeutic use
Protease Inhibitors therapeutic use
Reverse Transcriptase Inhibitors therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1471-2334
- Volume :
- 20
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- BMC infectious diseases
- Publication Type :
- Academic Journal
- Accession number :
- 32689975
- Full Text :
- https://doi.org/10.1186/s12879-020-05240-y