UK Chelsea and Westminster NHS Foundation Trust started clinical trail of Efficacy of BIC/F/TAF Versus Standard of Care in the Treatment of New HIV Infection Diagnoses

Photo by Alev Takil

Chelsea and Westminster NHS Foundation Trust is recruiting patients for the clinical trial of Efficacy of BIC/F/TAF Versus Standard of Care in the Treatment of New HIV Infection Diagnoses in the Context of 'Test and Treat' (BIC-T&T).

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.

Among primary outcome measures is the rate of HIV viral load response to first-line anti-retroviral treatment.

The study will take place at the Brighton and Sussex University Hospitals NHS Trust Lawson Unit Royal Sussex County Hospital, Brighton, United Kingdom and Chelsea and Westminster Hospital NHS Foundation Trust, London, United Kingdom.

The Inclusion Criteria are:

  • Confirmed diagnosis of HIV-1 as per local clinic definition less than 14 days before day treatment is to be initiated.
  • A female may be eligible to enter and participate in the study if she:
    1. is of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or,
    2. is of child-bearing potential with a negative pregnancy test at Screening (& baseline visit) and agrees to use one of the methods of contraception to avoid pregnancy indicated in Appendix 4 during the study and for a period of 12 weeks after the study.
  • Men who have partners who are women of childbearing potential (WOCBP - definition in Appendix 4) must be using an adequate method of contraception as listed in Appendix 4 to avoid pregnancy in their partner throughout the study and for a period of at least 12 weeks after the study.

The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT04653194

Clinical Research News

Upcoming Clinical Trials

3