HIV TreatmentNCT06829082
Real-Life Outcomes of TAF/FTC/BIC in HIV Patients in Colombia
An observational study of HIV Treatment, run by Servicios de Salud IPS Suramericana S.A.S at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Treatment
- What is being tested?
- BIKTARVY 50Mg-200Mg-25Mg Tablet
- Type of treatment
- Pill or oral medicine
- How many people
- 161 participants
- Where
- 1 siteColombia
- Study dates
- 15 Nov 2024to 17 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who meet the defined selection criteria within the established time frame for the search will be included.
Who may be able to join
- Male or female patients aged 18 years or older.
- Individuals with a confirmed HIV diagnosis.
- Individuals enrolled in EPS SURA during the study period.
- Patients receiving treatment with the TAF/FTC/BIC regimen.
Who cannot join
- Patients with a concurrent diagnosis of tuberculosis.
- Pregnant patients during the study period.
- Patients with virologic failure.
- Patients who started treatment with TAF/FTC/BIC but changed providers or discontinued treatment before completing six months of therapy.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Servicios de Salud IPS Suramericana S.A.S.
Medellín, Antioquia
About this study
Official title: 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
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
- HIV Treatment
- Being tested
- BIKTARVY 50Mg-200Mg-25Mg Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIKTARVY 50Mg-200Mg-25Mg TabletDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness: Virological Suppression
Measured: From enrollment to weeks 24 and 48
Effectiveness: CD4 T-Lymphocytes count
Measured: From enrollment to weeks 24 and 48
Security: Treatment-Related Adverse Events
Measured: From enrollment to weeks 24 and 48
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to weeks 24 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start15 Nov 2024
- Primary completion17 Jan 2025
- Study completion17 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Servicios de Salud IPS Suramericana S.A.S
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829082
- Sponsor's protocol ID
- SR-GL-003
- Status last verified
- Feb 2025
- First submitted
- 3 Feb 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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).
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06829082
- Acronym / sponsor ID
- SR-GL-003
- Conditions
- HIV Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Servicios de Salud IPS Suramericana S.A.SUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 17 Jan 2025 (actual)
- Study completion
- 17 Jan 2025 (actual)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who meet the defined selection criteria within the established time frame for the search will be included.
Key inclusion criteria (4 listed)
- Male or female patients aged 18 years or older.
- Individuals with a confirmed HIV diagnosis.
- Individuals enrolled in EPS SURA during the study period.
- Patients receiving treatment with the TAF/FTC/BIC regimen.
Key exclusion criteria (4 listed)
- Patients with a concurrent diagnosis of tuberculosis.
- Pregnant patients during the study period.
- Patients with virologic failure.
- Patients who started treatment with TAF/FTC/BIC but changed providers or discontinued treatment before completing six months of therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIKTARVY 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. | Drug | – |
Primary outcome
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
4 secondary outcomes
Security: Paraclinical Results: Hepatic and Renal Function, and Lipid Profile
Time frame: From enrollment to weeks 24 and 48
Adherence to Treatment
Time frame: From enrollment to week 48
Security; Hepatic function
Time frame: From enrollment to week 48
Security: Renal function
Time frame: From enrollment to weeks 24 and 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Individual participant dataSharing planned: 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Treatment, run by Servicios de Salud IPS Suramericana S.A.S at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness: Virological Suppression (time frame: From enrollment to weeks 24 and 48). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.