Clinical Trials Directory

Trials / Completed

CompletedNCT06829082

Real-Life Outcomes of TAF/FTC/BIC in HIV Patients in Colombia

Clinical Effectiveness, Adherence, Clinical and Paraclinical Outcomes Associated With Tenofovir Alafenamide/Emtricitabine/Bictegravir (TAF/FTC/BIC) in Patients Diagnosed With Human Immunodeficiency Virus HIV) in Colombia: A Real-Life Study

Status
Completed
Phase
Study type
Observational
Enrollment
161 (actual)
Sponsor
Servicios de Salud IPS Suramericana S.A.S · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

HIV remains a major global health issue, with 38 million people affected, and significant challenges in diagnosis and treatment due to stigma and socioeconomic factors. In Colombia, the epidemic is concentrated among men who have sex with men, with 165,405 people living with HIV and 14,670 new cases reported in 2023. Barriers to treatment access are exacerbated by social factors and Venezuelan migration. While integrase inhibitors like TAF/FTC/BIC have shown effectiveness, real-world data in Colombia is limited. This study evaluates adherence, effectiveness, and clinical outcomes of TAF/FTC/BIC in 169 patients within the EPS SURA program, contributing context-specific evidence.

Conditions

Interventions

TypeNameDescription
DRUGBIKTARVY 50Mg-200Mg-25Mg TabletAntiretroviral therapy (ART) has advanced with the introduction of integrase strand transfer inhibitors (INSTIs), such as the fixed-dose combination of tenofovir alafenamide/emtricitabine/bictegravir (TAF/FTC/BIC), known as Biktarvy®. This regimen is preferred for its high genetic barrier to resistance, minimal drug interactions, and once-daily, single-tablet formulation, which enhances adherence and long-term treatment outcomes. While clinical trials have demonstrated its efficacy, real-world data specific to Colombia are lacking.

Timeline

Start date
2024-11-15
Primary completion
2025-01-17
Completion
2025-01-17
First posted
2025-02-17
Last updated
2025-02-17

Locations

1 site across 1 country: Colombia

Source: ClinicalTrials.gov record NCT06829082. Inclusion in this directory is not an endorsement.