An observational study in HIV Treatment, sponsored by Servicios de Salud IPS Suramericana S.A.S. Completed at 1 site in Colombia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-17.
Sponsored by Servicios de Salud IPS Suramericana S.A.S · Observational
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.
This is the only study on the registry with Servicios de Salud IPS Suramericana S.A.S as lead sponsor.
Counted across the registry records on this site, refreshed daily.
All patients who meet the defined selection criteria within the established time frame for the search will be included.
Exclusion Criteria:
Antiretroviral 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.
Effectiveness: Virological Suppression
Time frame: From enrollment to weeks 24 and 48
Effectiveness: CD4 T-Lymphocytes count
Time frame: From enrollment to weeks 24 and 48
Security: Treatment-Related Adverse Events
Time frame: From enrollment to weeks 24 and 48
Security: Paraclinical Results: Hepatic and Renal Function, and Lipid Profile
The lipid profile will be evaluated using HDL and LDL levels before the start of treatment and at 24 and 48 weeks of treatment.
Time frame: From enrollment to weeks 24 and 48
Adherence to Treatment
Adherence will be measured using pharmacy claims information with the Proportion of Days Covered (PDC). PDC calculates the proportion of days the patient has access to the medication over a specified period.
Time frame: From enrollment to week 48
Security; Hepatic function
Liver function will be evaluated by AST and ALT enzymes and total bilirubin levels before the start of treatment and at 24 and 48 weeks of treatment.
Time frame: From enrollment to week 48
Security: Renal function
Renal function will be assessed by serum creatinine levels before the start of treatment and at 24 and 48 weeks of treatment.
Time frame: From enrollment to weeks 24 and 48
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Following the results of the study, they will be analyzed and evaluated by the team designated for this purpose. When the final version of the study product has been obtained and the draft manuscript has been reviewed and approved by the authors, it will be submitted to the journal selected and agreed upon by the principal investigator, according to the impact classification of the publication. In addition, it will be presented at a previously selected scientific event (congresses, symposia, among others). Publications will comply with the guidelines of the International Committee of Medical Journal Editors (ICMJE). Likewise, all individuals who meet the authorship criteria defined by the ICMJE will be recognized as authors of the publications (http://www.icmje.org).
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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