HIV InfectionsPhase 4TLACAELELNCT07138144

Efficacy, Safety, and ToLerability of Switching to A Two-Drug Regimen With DTG/3TC Compared to Maintaining A Three-Drug REgimen With BIC/FTC/TAF or DTG/3TC/ABC in ViroLogically SupprEssed PeopLe Living With HIV After 24 and 48 Weeks of Follow-Up

A Phase 4 study testing Standard Medical Therapy and dual therapy in people with HIV Infections, run by José Antonio Mata Marín at 1 site in Mexico.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: HIV Infections
What is being tested?: Standard Medical Therapy and dual therapy
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 156 participants
Where: 1 siteMexico
Study dates: 12 Jul 2025to 30 Jul 2026
Phase: Phase 4
Are there results?: Not yet: the study is under way

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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

PLWH aged over 18 years.
Virologically suppressed for at least 48 weeks prior to study enrollment.
On ART with Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) or Dolutegravir/Lamivudine/Abacavir (DTG/3TC/ABC).
No history of virologic failure.
Willing to participate in the study.
Signed written informed consent.
HIV-1 RNA <50 copies/mL within 4 weeks prior to randomization.
eGFR by CKD-EPI ≥60 mL/min.

Who cannot join

Pregnant or breastfeeding patients.
Known allergies to any component of the antiretroviral regimens.
Coinfection with hepatitis B and/or hepatitis C virus.
Concomitant medications that interact with any component of the ART regimens.
Diagnosis of malignancy prior to randomization.
Use of recreational drugs with anorexigenic potential (crystal meth, methamphetamines, cocaine) within 60 days prior to randomization.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mexico1 site, 1 recruiting

Hospital de Infectología, Centro Médico Nacional La Raza
Mexico City, Mexico City, 02990
José A Mata Marin, Master, 55 5724 5900, jamatamarin@gmail.com
José A Mata Marin, Master
Recruiting

Other trials in Mexico

About this study

Official title: Efficacy, Safety, and Tolerability of Switching to a Two-Drug Regimen With DTG/3TC Compared to Maintaining a Three-Drug Regimen With BIC/FTC/TAF or DTG/3TC/ABC in Virologically Suppressed PeopLe Living With HIV After 24 and 48 Weeks of Follow-Up

This is a phase 4, randomized, controlled, open-label, single-center clinical trial conducted at the Hospital de Infectología, National Medical Center "La Raza." The study employs a non-inferiority design with follow-up assessments at 24 and 48 weeks. The study will enroll 156 PLWH aged ≥18 years who are on ART with BIC/FTC/TAF or DTG/3TC/ABC and have maintained virological suppression (HIV-1 RNA <50 copies/mL) for at least 48 weeks. Participants will be randomized in a 2:1 ratio: 104 to switch to DTG/3TC and 52 to continue their current regimen (control group).

Read the detailed description

Since the identification of the human immunodeficiency virus (HIV), developing effective, safe, and well-tolerated antiretroviral therapy (ART) for people living with HIV (PLWH) has been a global health priority. Advances in ART have significantly improved the prognosis for PLWH, achieving life expectancies comparable to the general population. However, three-drug regimens, such as bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) or dolutegravir/lamivudine/abacavir (DTG/3TC/ABC), are associated with metabolic, renal, and cardiovascular adverse effects, particularly in the Mexican population, which has a high prevalence of metabolic syndrome.

Clinical trials, including GEMINI, TANGO, SALSA, RUMBA, PASO DOBLE, and DYAD, have demonstrated that two-drug regimens, such as dolutegravir/lamivudine (DTG/3TC), offer comparable virological efficacy and improved tolerability. Reducing the pharmacological burden may minimize adverse effects while maintaining viral suppression. The impact of metabolic disturbances on fat weight gain remains a controversial issue.

Objectives General Objective To compare the effectiveness, safety, and tolerability of switching to a DTG/3TC regimen versus continuing BIC/FTC/TAF or DTG/3TC/ABC in virally suppressed PLWH at 24 and 48 weeks of treatment.

Secondary Objectives

Assess changes in lipid profile, body mass index (BMI), and abdominal circumference.
Evaluate alterations in glucose metabolism.
Measure changes in blood pressure and cardiovascular risk using Framingham and AHA/ACC scales.
Analyze changes in body composition (fat, water, muscle).
Document adverse events associated with ART. Study Design This is a phase 4, randomized, controlled, open-label, single-center clinical trial conducted at the Hospital de Infectología, National Medical Center "La Raza." The study employs a non-inferiority design with follow-up assessments at 24 and 48 weeks. The study will enroll 156 PLWH aged ≥18 years who are on ART with BIC/FTC/TAF or DTG/3TC/ABC and have maintained virological suppression (HIV-1 RNA <50 copies/mL) for at least 48 weeks. Participants will be randomized in a 2:1 ratio: 104 to switch to DTG/3TC and 52 to continue their current regimen (control group).

Inclusion Criteria

Age ≥18 years.
Virological suppression (HIV-1 RNA <50 copies/mL) for ≥48 weeks.
Estimated glomerular filtration rate (eGFR) ≥60 mL/min.
Signed informed consent. Exclusion Criteria
Pregnancy or breastfeeding.
Hepatitis B or C coinfection.
Active malignancy.
Use of recreational drugs or medications with significant interactions with ART.

Procedures Following approval by the local ethics committee, participant recruitment will commence. Participants will be followed continuously for 48 weeks. Data will be collected on efficacy (viral suppression), safety (adverse events), and tolerability (patient-reported outcomes and clinical assessments).

Data Management and Statistical Analysis

Patient data will remain confidential and accessible only to study investigators. Data will be recorded in an SPSS database. Statistical analyses will include:

Kolmogorov-Smirnov test for normality.
χ² test for categorical variables.
Student's t-test or Mann-Whitney U test for continuous variables, as appropriate.
ANOVA for group comparisons.
Paired tests for within-group changes. A significance level of p ≤ 0.05 will be applied.

Feasibility The Hospital de Infectología, National Medical Center "La Raza," has the necessary infrastructure, trained personnel, and access to study medications to conduct this trial. The study is independent and not sponsored by any pharmaceutical company.

Conditions: HIV Infections
Being tested: Standard Medical Therapy, dual therapy
Keywords: HIV, DTG/3TC, BIC/TAF/FTC, dual therapy, non-inferiority
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Standard Medical TherapyDrug
Also called INSTI
Intervention arm will be dual therapy oh DTG 50 mg/ 3TC 300 mg, this will be compared to standar therapy of 3 drugs with: Bictegravir 50 mg / tenofovir alafenamide 25 mg / emtricitabine 200 mg or dolutegravir 50 mg / lamivudine 300 mg / abacavir 600 mg, both combinations in a single tablet.
dual therapyDrug
Also called DTG/3TC
Intervention arm will be dual therapy oh DTG 50 mg/ 3TC 300 mg, this will be compared to standar therapy of 3 drugs

Study groups in NCT07138144
Study group	Role	What they receive
Standar therapy	Active comparator	Bictegravir 50 mg / tenofovir alafenamide 25 mg / emtricitabine 200 mg or dolutegravir 50 mg / lamivudine 300 mg / abacavir 600 mg, both combinations in a single tablet, will be used as standard therapy Receives: Drug: Standard Medical Therapy
dual therapy	Experimental	This arm is the experimental one, with dual therapy, 2 drugs: Dolutegravir 50 mg/Lamivudina 300 mg, in a single tablet. Receives: Drug: dual therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Effectiveness.
Effectiveness: Individuals with >50 copies/ml.
Measured: 24 and 48 weeks.
Safety of switching ART regimen with an INSTI to DTG/3TC.
Number of participants with treatment-related adverse events as assessed of serious adverse events (WHO grade 3 or 4) for PWH treated with DTG/3TC at 24 and 48 weeks, expressed in proportions of new cases.
Measured: 24 and 48 weeks.
Tolerability of switching ART regimen with an INSTI to DTG/3TC.
Maintaining ART with DTG/3TC without changes, interruptions, or substitutions due to adverse effects or perceived discomfort.
Measured: 24 and 48 weeks.

Secondary outcomes (6)

Changes in lipid profile.
Changes in total cholesterol, HDL cholesterol, and triglycerides, measured in mg/dL.
Measured: 24 and 48 weeks
Changes in body mass index
To evaluate changes in body mass index (BMI, kg/m²) at weeks 24 and 48.
Measured: 24 and 48 weeks.
Changes in waist circumference.
To evaluate changes greater than 90 cm in waist circumference at weeks 24 and 48.
Measured: 24 and 48 weeks.
Glucose metabolism disorders.
To determine changes at weeks 24 and 48, including the development of prediabetes or diabetes.
Measured: 24 and 48 weeks.
Assess changes in blood pressure and cardiovascular risk
Framingham and AHA/ACC scales
Measured: 24 and 48 weeks
Measure body composition
fat, water, muscle
Measured: 24 and 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jul 202530 Jul 2026

First posted22 Aug 2025
Study start12 Jul 2025
Primary completion28 Feb 2026 (estimated)
Study completion30 Jul 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies 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: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This is a phase 4, randomized, controlled, open-label, single-center clinical trial conducted at the Hospital de Infectología, National Medical Center "La Raza." The study employs a non-inferiority design with follow-up assessments at 24 and 48 weeks. The study will enroll 156 PLWH aged ≥18 years who are on ART with BIC/FTC/TAF or DTG/3TC/ABC and have maintained virological suppression (HIV-1 RNA \<50 copies/mL) for at least 48 weeks. Participants will be randomized in a 2:1 ratio: 104 to switch to DTG/3TC and 52 to continue their current regimen (control group).
Masking: None (open label)
Enrolment: 156 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07138144
Sponsor's protocol ID: R-2025-3502-186
Acronym: TLACAELEL
Status last verified: Aug 2025
First submitted: 4 Aug 2025
Last updated: 22 Aug 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The data cannot be shared openly because it contains personal information about the participants; if required, it can be requested from the corresponding author.

Publications

Rolle CP, Castano J, Nguyen V, Hinestrosa F, DeJesus E. Efficacy, Safety, and Tolerability of Switching From Bictegravir/Emtricitabine/Tenofovir Alafenamide to Dolutegravir/Lamivudine Among Adults With Virologically Suppressed HIV: The DYAD Study. Open Forum Infect Dis. 2024 Sep 26;11(10):ofae560. doi: 10.1093/ofid/ofae560. eCollection 2024 Oct.
PubMed 39416993
Llibre JM, Brites C, Cheng CY, Osiyemi O, Galera C, Hocqueloux L, Maggiolo F, Degen O, Taylor S, Blair E, Man C, Wynne B, Oyee J, Underwood M, Curtis L, Bontempo G, van Wyk J. Efficacy and Safety of Switching to the 2-Drug Regimen Dolutegravir/Lamivudine Versus Continuing a 3- or 4-Drug Regimen for Maintaining Virologic Suppression in Adults Living With Human Immunodeficiency Virus 1 (HIV-1): Week 48 Results From the Phase 3, Noninferiority SALSA Randomized Trial. Clin Infect Dis. 2023 Feb 18;76(4):720-729. doi: 10.1093/cid/ciac130.
PubMed 35235656
De Scheerder MA, Degroote S, Delporte M, Kiselinova M, Trypsteen W, Vincke L, De Smet E, Van Den Eeckhout B, Schrooyen L, Verschoore M, Muccini C, Vanherrewege S, Caluwe E, De Buyser S, Gerlo S, Blomme E, Vandekerckhove L. In-depth Analysis of the HIV Reservoir Confirms Effectiveness and Safety of Dolutegravir/Lamivudine in a Phase 4 Randomized Controlled Switch Trial (RUMBA). J Infect Dis. 2025 Feb 4;231(1):e91-e100. doi: 10.1093/infdis/jiae405.
PubMed 39226296
van Wyk J, Ajana F, Bisshop F, De Wit S, Osiyemi O, Portilla Sogorb J, Routy JP, Wyen C, Ait-Khaled M, Nascimento MC, Pappa KA, Wang R, Wright J, Tenorio AR, Wynne B, Aboud M, Gartland MJ, Smith KY. Efficacy and Safety of Switching to Dolutegravir/Lamivudine Fixed-Dose 2-Drug Regimen vs Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Phase 3, Randomized, Noninferiority TANGO Study. Clin Infect Dis. 2020 Nov 5;71(8):1920-1929. doi: 10.1093/cid/ciz1243.
PubMed 31905383

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy, Safety, and Tolerability of Switching to a Two-Drug Regimen With DTG/3TC Compared to Maintaining a Three-Drug Regimen With BIC/FTC/TAF or DTG/3TC/ABC in Virologically Suppressed PeopLe Living With HIV After 24 and 48 Weeks of Follow-Up
ClinicalTrials.gov ID: NCT07138144
Acronym / sponsor ID: TLACAELEL / R-2025-3502-186
Conditions: HIV Infections
Keywords: HIV, DTG/3TC, BIC/TAF/FTC, dual therapy, non-inferiority
Phase: Phase 4
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 156 participants (estimated)
Lead sponsor: José Antonio Mata MarínOther government
Study start: 12 Jul 2025 (actual)
Primary completion: 28 Feb 2026 (estimated)
Study completion: 30 Jul 2026 (estimated)
First posted: 22 Aug 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.

Detailed description

Secondary Objectives

Assess changes in lipid profile, body mass index (BMI), and abdominal circumference.
Evaluate alterations in glucose metabolism.
Measure changes in blood pressure and cardiovascular risk using Framingham and AHA/ACC scales.
Analyze changes in body composition (fat, water, muscle).
Document adverse events associated with ART. Study Design This is a phase 4, randomized, controlled, open-label, single-center clinical trial conducted at the Hospital de Infectología, National Medical Center "La Raza." The study employs a non-inferiority design with follow-up assessments at 24 and 48 weeks. The study will enroll 156 PLWH aged ≥18 years who are on ART with BIC/FTC/TAF or DTG/3TC/ABC and have maintained virological suppression (HIV-1 RNA <50 copies/mL) for at least 48 weeks. Participants will be randomized in a 2:1 ratio: 104 to switch to DTG/3TC and 52 to continue their current regimen (control group).

Inclusion Criteria

Age ≥18 years.
Virological suppression (HIV-1 RNA <50 copies/mL) for ≥48 weeks.
Estimated glomerular filtration rate (eGFR) ≥60 mL/min.
Signed informed consent. Exclusion Criteria
Pregnancy or breastfeeding.
Hepatitis B or C coinfection.
Active malignancy.
Use of recreational drugs or medications with significant interactions with ART.

Data Management and Statistical Analysis

Patient data will remain confidential and accessible only to study investigators. Data will be recorded in an SPSS database. Statistical analyses will include:

Kolmogorov-Smirnov test for normality.
χ² test for categorical variables.
Student's t-test or Mann-Whitney U test for continuous variables, as appropriate.
ANOVA for group comparisons.
Paired tests for within-group changes. A significance level of p ≤ 0.05 will be applied.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: This is a phase 4, randomized, controlled, open-label, single-center clinical trial conducted at the Hospital de Infectología, National Medical Center "La Raza." The study employs a non-inferiority design with follow-up assessments at 24 and 48 weeks. The study will enroll 156 PLWH aged ≥18 years who are on ART with BIC/FTC/TAF or DTG/3TC/ABC and have maintained virological suppression (HIV-1 RNA <50 copies/mL) for at least 48 weeks. Participants will be randomized in a 2:1 ratio: 104 to switch to DTG/3TC and 52 to continue their current regimen (control group).

Arm	Type	Receives
Standar therapy	Active comparator	Drug: Standard Medical TherapyBictegravir 50 mg / tenofovir alafenamide 25 mg / emtricitabine 200 mg or dolutegravir 50 mg / lamivudine 300 mg / abacavir 600 mg, both combinations in a single tablet, will be used as standard therapy
dual therapy	Experimental	Drug: dual therapyThis arm is the experimental one, with dual therapy, 2 drugs: Dolutegravir 50 mg/Lamivudina 300 mg, in a single tablet.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

PLWH aged over 18 years.
Virologically suppressed for at least 48 weeks prior to study enrollment.
On ART with Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) or Dolutegravir/Lamivudine/Abacavir (DTG/3TC/ABC).
No history of virologic failure.
Willing to participate in the study.

Key exclusion criteria (6 listed)

Pregnant or breastfeeding patients.
Known allergies to any component of the antiretroviral regimens.
Coinfection with hepatitis B and/or hepatitis C virus.
Concomitant medications that interact with any component of the ART regimens.
Diagnosis of malignancy prior to randomization.

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
Standard Medical TherapyAlso: INSTIIntervention arm will be dual therapy oh DTG 50 mg/ 3TC 300 mg, this will be compared to standar therapy of 3 drugs with: Bictegravir 50 mg / tenofovir alafenamide 25 mg / emtricitabine 200 mg or dolutegravir 50 mg / lamivudine 300 mg / abacavir 600 mg, both combinations in a single tablet.	Drug	Standar therapy
dual therapyAlso: DTG/3TCIntervention arm will be dual therapy oh DTG 50 mg/ 3TC 300 mg, this will be compared to standar therapy of 3 drugs	Drug	dual therapy

Primary outcome

Effectiveness.
Time frame: 24 and 48 weeks.
Effectiveness: Individuals with >50 copies/ml.
Safety of switching ART regimen with an INSTI to DTG/3TC.
Time frame: 24 and 48 weeks.
Number of participants with treatment-related adverse events as assessed of serious adverse events (WHO grade 3 or 4) for PWH treated with DTG/3TC at 24 and 48 weeks, expressed in proportions of new cases.
Tolerability of switching ART regimen with an INSTI to DTG/3TC.
Time frame: 24 and 48 weeks.
Maintaining ART with DTG/3TC without changes, interruptions, or substitutions due to adverse effects or perceived discomfort.

6 secondary outcomes

Changes in lipid profile.
Time frame: 24 and 48 weeks
Changes in body mass index
Time frame: 24 and 48 weeks.
Changes in waist circumference.
Time frame: 24 and 48 weeks.
Glucose metabolism disorders.
Time frame: 24 and 48 weeks.
Assess changes in blood pressure and cardiovascular risk
Time frame: 24 and 48 weeks
Measure body composition
Time frame: 24 and 48 weeks

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
Background: PubMed 39416993Rolle CP, Castano J, Nguyen V, Hinestrosa F, DeJesus E. Efficacy, Safety, and Tolerability of Switching From Bictegravir/Emtricitabine/Tenofovir Alafenamide to Dolutegravir/Lamivudine Among Adults With Virologically Suppressed HIV: The DYAD Study. Open Forum Infect Dis. 2024 Sep 26;11(10):ofae560. doi: 10.1093/ofid/ofae560. eCollection 2024 Oct.
Background: PubMed 35235656Llibre JM, Brites C, Cheng CY, Osiyemi O, Galera C, Hocqueloux L, Maggiolo F, Degen O, Taylor S, Blair E, Man C, Wynne B, Oyee J, Underwood M, Curtis L, Bontempo G, van Wyk J. Efficacy and Safety of Switching to the 2-Drug Regimen Dolutegravir/Lamivudine Versus Continuing a 3- or 4-Drug Regimen for Maintaining Virologic Suppression in Adults Living With Human Immunodeficiency Virus 1 (HIV-1): Week 48 Results From the Phase 3, Noninferiority SALSA Randomized Trial. Clin Infect Dis. 2023 Feb 18;76(4):720-729. doi: 10.1093/cid/ciac130.
Background: PubMed 39226296De Scheerder MA, Degroote S, Delporte M, Kiselinova M, Trypsteen W, Vincke L, De Smet E, Van Den Eeckhout B, Schrooyen L, Verschoore M, Muccini C, Vanherrewege S, Caluwe E, De Buyser S, Gerlo S, Blomme E, Vandekerckhove L. In-depth Analysis of the HIV Reservoir Confirms Effectiveness and Safety of Dolutegravir/Lamivudine in a Phase 4 Randomized Controlled Switch Trial (RUMBA). J Infect Dis. 2025 Feb 4;231(1):e91-e100. doi: 10.1093/infdis/jiae405.
Background: PubMed 31905383van Wyk J, Ajana F, Bisshop F, De Wit S, Osiyemi O, Portilla Sogorb J, Routy JP, Wyen C, Ait-Khaled M, Nascimento MC, Pappa KA, Wang R, Wright J, Tenorio AR, Wynne B, Aboud M, Gartland MJ, Smith KY. Efficacy and Safety of Switching to Dolutegravir/Lamivudine Fixed-Dose 2-Drug Regimen vs Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Phase 3, Randomized, Noninferiority TANGO Study. Clin Infect Dis. 2020 Nov 5;71(8):1920-1929. doi: 10.1093/cid/ciz1243.
Individual participant dataSharing planned: No. The data cannot be shared openly because it contains personal information about the participants; if required, it can be requested from the corresponding author.

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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.

Hospital de Infectología, Centro Médico Nacional La Raza

Mexico City, Mexico

55 5724 5900

jamatamarin@gmail.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Standard Medical Therapy and dual therapy in people with HIV Infections, run by José Antonio Mata Marín at 1 site in Mexico.

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 8 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 22 Aug 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 Mexico. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness. (time frame: 24 and 48 weeks.). 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?

On the ClinicalTrials.gov record for NCT07138144, which also lists 4 linked publications.

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 22 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.