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.

BMC Infectious Diseases
Collins C IwujiAnna Maria Geretti

Abstract

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). 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 t...Continue Reading

References

Dec 26, 2001·Journal of Clinical Epidemiology·A C JusticeUNKNOWN Adult AIDS Clinical Trials Unit Outcomes Committee
Oct 25, 2003·Antimicrobial Agents and Chemotherapy·Katharina WolfBarbara Schmidt
Nov 25, 2003·The New England Journal of Medicine·Nina Friis-MøllerUNKNOWN Data Collection on Adverse Events of Anti-HIV Drugs (DAD) Study Group
Dec 3, 2003·The Journal of Antimicrobial Chemotherapy·Dan TurnerMark A Wainberg
Mar 27, 2012·The Journal of Infectious Diseases·Kim C E SigaloffUNKNOWN PharmAccess African Studies to Evaluate Resistance (PASER)
May 23, 2012·AIDS Patient Care and STDs·E Jennifer EdelmanUNKNOWN Vacs Project Team
Jun 29, 2013·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Peter J RuaneKitty Yale
Jul 12, 2014·The New England Journal of Medicine·Nicholas I PatonUNKNOWN EARNEST Trial Team
Jul 8, 2015·Antimicrobial Agents and Chemotherapy·Nicolas A MargotChristian Callebaut
Aug 9, 2016·Nature Medicine·Katherine M BrunerRobert F Siliciano
Oct 26, 2016·BMJ : British Medical Journal·Sandra M EldridgeUNKNOWN PAFS consensus group
Dec 13, 2017·Current Opinion in Infectious Diseases·Jens LundgrenLene Ryom

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Citations

Apr 27, 2021·Frontiers in Cardiovascular Medicine·Shiridhar KashyapManish K Gupta

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Methods Mentioned

BETA
contraception
pregnancy
blood draw

Software Mentioned

MOBIDIP
EARNEST
Sealed
MACRO

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