Efficacy, tolerability and acceptability of Biktarvy by TPLWH

• Research type

  Research Study

• Full title

  Efficacy, tolerability and acceptability of the single tablet regimen (STR) Biktarvy® by trans people living with HIV (TPLWH)

• IRAS ID

  302393

• Contact name

  Marta Boffito

• Contact email

  marta.boffito@nhs.net

• Sponsor organisation

  Chelsea and Westminster NHS Foundation Trust

• Eudract number

  2020-001070-29

• Clinicaltrials.gov Identifier

  NCT04944654

• Duration of Study in the UK

  3 years, 0 months, 1 days

• Research summary

  We here propose a clinical trial for TPLWH (Trans people living with HIV) who are stable on cART (combined antiretroviral therapy) with an undetectable viral load or a detectable viral load but no resistance to NRTIs (nucleoside reverse transcriptase inhibitors) and InSTI (integrase strand transfer inhibitor). Following written consent and screening procedures, study subjects will undergo a switch (or will restart) of their combination antiretroviral therapy (cART) to Biktarvy. The goal of this research project is to recruit an understudied population into a controlled clinical trial aimed at optimizing TPLWH cART. This will be demonstrated by measuring viral load outcomes at regular intervals, with a focus on viral load results 48 weeks after Biktarvy initiation (primary outcome).

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  21/LO/0784

• Date of REC Opinion

  11 Jan 2022

• REC opinion

  Further Information Favourable Opinion