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 virologically suppressed HIV-1 infected adults harbouring drug resistance mutations

niversity of Sussex0 sites100 target enrollmentJune 19, 2019

Overview

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32689975/ protocol (added 22/07/2020)

Registry

who.int

Start Date

June 19, 2019

End Date

February 28, 2023

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of Sussex

•Current participant inclusion criteria as of 23/07/2021:
•1\. 18 years and above
•2\. On a bPI\-based ART regimen with documented HIV\-1 RNA \<50 copies/mL for at least 6 months on current regimen and at screening (A switch from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF), lamivudine (3TC) to emtricitabine (FTC), or splitting co\-formulated tablets to their individual component or vice versa will not be considered true regimen changes)
•3\. Must have a historical genotype
•4\. Eligible drug resistance mutations in historical genotype include at least one of the following:
•4\.1\. M184V/I with or without any nucleoside analogue mutation (e.g. L74I/V, Y115F, K70E/G/Q/T/N/S)
•4\.2\. M184V/I alone (maximum of 20 participants with isolated M184V/I mutation with or without NNRTI mutations)
•4\.3\. Up to 2 TAMs (M41L, D67N, K70R, L210W, T215F/Y, or K219Q/E/N/R) with or without M184V/I
•4\.4\. Any of the above with or without NNRTI mutations
•5\. If previous INSTI exposure, participants should not have experienced virological failure on the INSTI regimen. Site must provide viral load history during the time participant was on INSTI for Chief Investigator review and confirmation of eligibility. Participants who experienced one of the following whilst on INSTI regimen will be excluded:

•Current participant exclusion criteria as of 23/07/2021:
•1\. Exclusion under drug resistance mutations include:
•1\.1\. Presence of any of the following mutations: K65R/N/E
•1\.2\. Presence of multidrug resistance mutations: T69ins, Q151M with or without A62V, V75I, F77L, F116Y
•1\.3\. Presence of INSTI mutations: H51Y, T66AIK, E92QGV, G118R, F121Y, E138KAT, G140ASC, Y143CRHKSGA, P145S, Q146P, S147G, Q148HKRN, S153YF, N155HSTD, S230R, R263K
•1\.4\. Three or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, or K219Q/E/N/R)
•2\. Individuals experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, or variceal bleeding)
•3\. An opportunistic illness within the 30 days prior to screening
•4\. Active tuberculosis infection
•5\. Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study (e.g., corticosteroids, immunoglobulins, and other immune\- or cytokine based therapies)