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

Completed

• Conditions: HIV Infections

• Registration Number: NCT06518213
• Lead Sponsor: University Hospital for Infectious Diseases, Croatia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-01
• Primary Completion: 2022-12-31
• Study Completion: 2024-03-31
• Status Verified: 2024-07
• Study First Submitted: 2024-07-12
• Study First Submitted QC: 2024-07-18
• Last Update Submitted: 2024-07-18
• Study First Posted: 2024-07-24
• Last Update Posted: 2024-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Virological suppression (HIV-1 RNA below 50 copies/mL plasma)	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 Outcome Measures

Name	Time	Method
Side effect to the drug BIC/FTC/TAF	through study completion, an average of 1 year	Side effect to the administered medication which required discontinuation of treatment
Change in CD4+/CD8+ T-lymphocytes ratio	6 and 12 months of treatment	Change in ratio of CD4+ and CD8+ T-lymphocytes measured after 6 and 12 months of treatment
HIV-1 RNA 50-200 copies/mL	6 and 12 months of treatment	HIV-1 RNA 50-200 copies/mL of plasma after 6 and 12 months of treatment
HIV-1 RNA above 200 copies/mL	6 and 12 months of treatment	HIV-1 RNA above 200 copies/mL of plasma after 6 and 12 months of treatment
Virological failure	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
Change in weight	6 and 12 months of treatment	Change in patient's weight in kilograms measured after 6 and 12 months of treatment
Number of CD4+ T-lymphocytes	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
Change in eGFR	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
Lipids concentration	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
Change in liver enzymes	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

Trial Locations

Locations (1)

University Hospital for Infectious Diseases ''Dr. Fran Mihaljevic''; 🇭🇷 Zagreb, City Of Zagreb, Croatia