Efficacy, Tolerability and Acceptability of Biktarvy by TPLWH

• Status: Not yet recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a clinical trial for TPLWH (Trans People Living with HIV) who are stable on cART with an undetectable viral load or a detectable viral load but no resistance to NRTIs and InSTI. 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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chelsea and Westminster NHS Foundation Trust
• Collaborators: Gilead Sciences; Imperial College London
• Treatments: Emtricitabine

Criteria

Inclusion Criteria:

• Participant self-identifies as transgender and/or has a current gender identity which differs from gender assigned at birth (includes all gender diverse people)

• Age > 18 years

• HIV infection diagnosis at any time before study consent

• Willing to sign an informed consent and take part in the study

• On an antiretroviral regimen with an undetectable viral load or off an antiretroviral regimen with a detectable viral load (the cART can have been stopped for any clinical or personal reason; if on cART with a detectable viral load and no resistance to any of the component of Biktarvy, the patient is also eligible.

• A female may be eligible to enter and participate in the study if she:

• 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,

• 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 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 3) must be using an adequate method of contraception as listed the Protocol to avoid pregnancy in their partner throughout the study and for a period of at least 12 weeks after the study.

Exclusion Criteria:

• Age < 18 years

• Unable to take part in the study according to the Investigator opinion (example:

unable to understand the study information leaflet, unable to provide written consent, etc.)

• History of virological failure while on a cART containing NRTIs and InSTIs and development of resistance to NRTIs and InSTI

• Use of medications that are known to interact with Biktarvy. Contraindications given in appendix 4 and full information on drug-drug interactions given in SmPC.

• Hypersensitivity to active substance or excipient of Biktarvy as listed in SmPC.

• Women planning pregnancy or who are pregnant or breast feeding.

• Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical or anal intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the Study medical monitor for inclusion of the subject prior to randomisation.

• Known acute or chronic viral hepatitis including, but not limited to, A, B, or C. Chronic hepatitis B and history of hepatitis C (cured) are allowed

• Any investigational drug within 30 days prior to the trial drug administration

• Any other condition (including illicit drug use or alcohol abuse) or laboratory results which, in the investigator's opinion, interfere with assessments or completion of the trial.