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

Phase 1

Active, not recruiting

• Conditions: MedDRA version: 20.0Level: LLTClassification code 10020441Term: Human immunodeficiency virus infection, unspecifiedSystem Organ Class: 100000004862; Human Immunodeficiency Virus (HIV) infection; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001070-29-ES
• Lead Sponsor: Chelsea and Westminster NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-09
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 50

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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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 and full information on drug-drug interactions given in SmPC.
•Hypersensitivity to active substance or excipient of Biktarvy as listed in SmPC.
•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 initiation of treatment
•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified