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NCT07859904
Study on Retention in Care and on Clinical Chracteristics of HIV-infected Women Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIKWO).
Conditions: HIV 1 Infection
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 100
Sponsor: Ente Ospedaliero Ospedali Galliera
Location: Galliera Hospital Genova
Summary
Women are an underrepresented population in clinical studies on HIV and antiretroviral therapy. This study aims to help bridge this gap by providing real-world data on therapeutic management with B/F/TAF (Biktarvy) in an exclusively female cohort, aiming to improve treatment personalization and the early identification of risk factors for poor retention and treatment failure in this population.
This study is single-center, ambispective observational. The retrospective component analyzes medical record data from June 2019 (the date BIC/FTC/TAF became available in Italy) to the study data cutoff. The prospective component involves data collection during routine follow-up visits up to December 31, 2027. No diagnostic or therapeutic procedures beyond standard clinical practice are involved.
The study opulation includes adult women (≥18 years of age) with a confirmed diagnosis of HIV-1 infection who have received at least one prescription for BIC/FTC/TAF at the Infectious Diseases Unit of E.O. Ospedali Galliera in Genoa from June 2019 to the present, with a documented follow-up of at least 6 months.
The primary objective of the study is to determine the 12- and 24-month retention-in-care rates among women treated with B/F/TAF (Biktarvy) and to identify factors associated with treatment maintenance and predictors of treatment discontinuation.
Secondary objectives of the study include:
* Percentage of women achieving/maintaining virologic suppression (\
Eligibility Criteria
Inclusion Criteria:
* Adult women
* at least 18 years
* documented HIV-1 infection
* actively receiving treatment with BIC/FTC/TAF started between 2019 and enrollment date
* at lest 6 months follow up after starting BIC/FTC/TAF
Exclusion Criteria:
* loss to follow up before 6 months from starting BIC/FTC/TAF
* unavailability of data/information on follow up after starting BIC/FTC/TAF
Source: ClinicalTrials.gov (NCT07859904). StuddyBuddy aggregates publicly available trial information.