The BIC T&T Study
Research type
Research Study
Full title
Efficacy of BIC/F/TAF versus standard of care in the treatment of new HIV infection diagnoses in the context of 'test and treat'
IRAS ID
271361
Contact name
Marta Boffito
Contact email
Sponsor organisation
Chelsea and Westminster Hospital NHS Foundation Trust
Eudract number
2019-003208-11
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
The administration of combination antiretroviral therapy (cART) to HIV-infected patients has been associated with a dramatic reduction in AIDS-related morbidity and mortality. Time to cART start is currently approximately 2-4 weeks after diagnosis, mostly deferred for reasons of waiting for baseline blood test results; in particular HIV genotype, CD4 count, OI screen and logistics of a consultant clinical review. Whilst there is a clear rationale for this delay there is a risk of loss to follow-up as well as the potential risk of onward viral transmission. The balance between “readiness” to start ART against pragmatic and practical safe initiation of treatment needs to be tested using currently available safe potent antiretroviral agents in a head-to-head comparison study to allow careful rigorous comparisons of outcomes.
This study will recruit 36 newly diagnosed HIV patients to be started on treatment immediately upon diagnosis. This would optimally be within 7 days, for eligibility to the study up to 14 days will be permissible. Patients will be randomised to one of two open-label combination therapies known to be highly effective; Biktarvy or Symtuza. The patients will receive study treatment for 48 weeks. The two therapies will be compared by the change in HIV viral load from start of treatment to 12 weeks. Further clinical data will be recorded for the trial patients and exploratory investigations undertaken. As those recruited to the trial may not be representative of the full cohort of newly diagnosed HIV patients there will also be data collected on all newly diagnosed patients in a given period. This data will contribute to conclusions on the benefits and issues of implementing test and treat.
REC name
London - South East Research Ethics Committee
REC reference
19/LO/1953
Date of REC Opinion
27 Jan 2020
REC opinion
Further Information Favourable Opinion