Incidence of Metabolic Syndrome in People Living With HIV Without ExperienCe to ART Who Start DoLutegravir Based-Regimen Compared With BictegrAvir Based-RegimeN (MICTLAN)

October 3, 2024 updated by: José Antonio Mata Marín, Instituto Mexicano del Seguro Social

Incidence of Metabolic Syndrome in People Living With HIV Without ExperienCe to ART Who Start DoLutegravir Based-Regimen Compared With BictegrAvir Based-RegimeN After 48 Weeks (MICTLAN Trial)

The aim of the study was to identify the incidence of MetS at 48 weeks for ATP III score in patients living with HIV (PLH) who started antiretroviral therapy (ART) with Dolutegravir based-regimen compared with Bictegravir based-regimen. MICTLAN is a randomized open clinical trial developed with men PLH who started ART randomized to BIC/FTC/TAF or DTG/3TC/ABC. Weight, height, blood pressure, and waist circumference and electriccircumference were measured during routine clinical care; in addition, electric bioimpedance were measured atmeasuredwas done; repeated measures of weight in kilograms were done at baseline, 24 and 48 weeks. Metabolic laboratory tests were done on each visit.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The aim of this study was to compare the incidence of MetS at 24 weeks by ATP III score in PLHpatients living with HIV who started antiretroviral therapy (ART) with Dolutegravir based-regimen vs. Bictegravir based-regimen. An open-label randomized clinical trial was conducted,from February 2021 through December 2022, in HIV clinic at the national medical center "La Raza", Mexico city. the primary endpoint was the incidence of MetS at 48 weeks comparing BIC/FTC/TAF with DTG/3TC/ABC in patients with HIV type 1 (HIV-1) infection starting ART.Study subjects were men who have sex with men (MSM) with HIV-1 infection ≥18 years old, living with HIV, naïve to ART (PLHIV). The trial enrolled residents of Mexico City and Mexico State from February 2021 through February 2024. Inclusion criteria were men over ≥18 years , a viral load of at least of 500 copies/ or more per milliliter, and a creatinine clearance over 60 ml/ per minute (CKD-EPI formula). Among the exclusion criteria were MetS, comorbidities or prescription of drugs associated with weight gain or weight loss or current treatment for tuberculosis. Each patient received a personalized eating plan based on the equivalent food system method adjusted to their energy requirements before starting treatment by a nutritionist . The primary endpoint was the incidence of MetS at week 24. Secondary objectives were the percentage of patients with an HIV-1 RNA level of less than 40 copies/ per mlilliliter, CD4+ count changes, and side-effect profile and safety, including findings on physical examination and laboratory analyses. Body composition was measured at baseline and at 24 weeks using a next generation bioimpedance device. Each patient was measured in duplicate to ensure better results and to avoid minimal changes. An ultrasonography (US) to measure visceral and subcutaneous fat was donemeasured. Waist circumference was also measured in the fasting state by using a non-retractable material flexible ruler. There was no testing of HIV resistance at screening. Patients with two confirmed elevations in the HIV-1 RNA level to 1000 copies or more per milliliter after week 24 were tested for drug resistance, together with their stored baseline samples. Weight and height were measured every medical visitduring routine clinical care, and recorded in electronic health records. Repeated measures of weight in kilograms (kg) were done at baseline 24 and 48 weeks. Descriptive results were summarized using median and interquartile range (IQR). Percentage was obtained in order to evaluate the weight gain classification. The main outcome variable was the incidence of MS at 48 weeks. We assessed weight change and metabolic changes at 48 weeks with a Wilcoxon signed-rank test. Mann Whitney U-test was used to compare between groups of INSTI. The effectiveness outcomes were analyzed in the intention-to-treat population and the safety outcomes were analyzed in the as-treated population. All analyses were conducted using SPSS software (version 29; SPSS IBM Corp., Armonk, NJ, USA)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
378

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico, 02990
        • Hospital de Infectología, "La Raza" National Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Men who have sex with men (MSM) with HIV-1 infection
  • ≥18 years old
  • Living with HIV
  • Naïve to ART
  • Creatinine clearance over 60 ml/ per minute (CKD-EPI formula)

Exclusion Criteria:

  • Metabolic Syndrome
  • Comorbidities or prescription of drugs associated with weight gain or weight loss
  • Current treatment for tuberculosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: BIC/TAF/FTC
Drug: Bictegravir
The aim of the study was to identify the incidence of MetS at 48 weeks for ATP III score in patients living with HIV (PLH) who started antiretroviral therapy (ART) with Dolutegravir based-regimen compared with Bictegravir based-regimen. A randomized open clinical trial was developed with men PLH who started ART randomized to BIC/FTC/TAF or DTG/3TC/ABC.
Active Comparator: DTG/ABC/3TC
Drug: Bictegravir
The aim of the study was to identify the incidence of MetS at 48 weeks for ATP III score in patients living with HIV (PLH) who started antiretroviral therapy (ART) with Dolutegravir based-regimen compared with Bictegravir based-regimen. A randomized open clinical trial was developed with men PLH who started ART randomized to BIC/FTC/TAF or DTG/3TC/ABC.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Metabolic Syndrome
Time Frame: 48 weeks
Incidence of MetS at 48 weeks for ATP III score in patients living with HIV (PLH) who started antiretroviral therapy (ART) with Dolutegravir based-regimen compared with Bictegravir based-regimen.
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Instituto Mexicano del Seguro Social

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 25, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 24, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R-2021-3502-084

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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