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NCT Number: NCT06518213

Efficacy and Safety of First-line ART With BIC/FTC/TAF Introduced at the First Clinical Visit

Bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) is a recommended first-line antiretroviral regimen. Croatia has a centralized care for people living with HIV (PLWH) and all persons are seen and treated in a single center, preferably in a same-day initiation model whenever suitable. This retrospective cohort study evaluated antiretroviral therapy (ART) naïve PLWH who initiated BIC/FTC/TAF, in a same-day model. The goal of the study is to assess safety and efficacy of this model by collecting information from the electronic database of the Croatian HIV Reference Centre.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital for Infectious Diseases ''Dr. Fran Mihaljevic''

Zagreb, City of Zagreb, 10000, Croatia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HIV seropositivity confirmed by a fourth generation test
  • the subject had not previously taken ART
  • ART was started within 24 hours of the first examination

Exclusion criteria

  • persons under 18 years of age
  • people who are pregnant, breastfeeding or planning to become pregnant
  • unacceptable interaction with a drug that the subject is already taking

Treatment and study plan

Primary outcomes

  1. Virological suppression (HIV-1 RNA below 50 copies/mL plasma)

    Time frame: 12±3 months of ART (BIC/FTC/TAF)

    Virological suppression (HIV-1 RNA below 50 copies/mL plasma) after 12±3 months of antiretroviral treatment with first-line ART (BIC/FTC/TAF) initiated at first clinical contact

Secondary outcomes

  1. HIV-1 RNA 50-200 copies/mL

    Time frame: 6 and 12 months of treatment

    HIV-1 RNA 50-200 copies/mL of plasma after 6 and 12 months of treatment

  2. HIV-1 RNA above 200 copies/mL

    Time frame: 6 and 12 months of treatment

    HIV-1 RNA above 200 copies/mL of plasma after 6 and 12 months of treatment

  3. Virological failure

    Time frame: 6 and 12 months of treatment

    Virological failure (HIV-1 RNA above 50 copies/mL) after 6 and 12 months of treatment with BIC/FTC/TAF

  4. Number of CD4+ T-lymphocytes

    Time frame: 6 and 12 months of treatment

    Change in the number of CD4+ T-lymphocytes per microL of blood compared to the initial value after 6 and 12 months of treatment

  5. Change in CD4+/CD8+ T-lymphocytes ratio

    Time frame: 6 and 12 months of treatment

    Change in ratio of CD4+ and CD8+ T-lymphocytes measured after 6 and 12 months of treatment

  6. Side effect to the drug BIC/FTC/TAF

    Time frame: through study completion, an average of 1 year

    Side effect to the administered medication which required discontinuation of treatment

  7. Change in weight

    Time frame: 6 and 12 months of treatment

    Change in patient's weight in kilograms measured after 6 and 12 months of treatment

  8. Change in eGFR

    Time frame: 6 and 12 months of treatment

    Change in estimated glomerular filtration rate (mL/min/1.73 m2) measured after 6 and 12 months of treatment

  9. Change in liver enzymes

    Time frame: 6 and 12 months of treatment

    Change in liver enzymes aspartate aminotransferase (AST), alanine aminotransferase (ALT) and gamma-glutamyl transpeptidase (GGT) concentration (U/L) measured after 6 and 12 months of treatment

  10. Lipids concentration

    Time frame: 6 and 12 months of treatment

    Change in lipids (total cholesterol, LDL, HDL and triglycerides) concentration (mmol/L) measured after 6 and 12 months of treatment

Sponsors and collaborators

Lead sponsor

University Hospital for Infectious Diseases, Croatia

Other

Registry information

Official study title

Efficacy and Safety of First-line Antiretroviral Therapy (ART) With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Introduced at the First Clinical Visit: a Real-life Retrospective Single Arm Single Center Study

Important dates

Study start
2019
Primary completion
2022
Study completion
2024
First posted
Jul 24, 2024
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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