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

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: Completed
• Conditions: HIV Infection; Metabolic Cardiovascular Syndrome; Antiretroviral Treatment
• Intervention / Treatment: Drug: Bictegravir

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: Interventional
• Enrollment (Actual): 378
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Incidence of Metabolic Syndrome	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

• Sponsor: Instituto Mexicano del Seguro Social

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2021
• Primary Completion (Actual): February 24, 2024
• Study Completion (Actual): February 28, 2024

Study Registration Dates

• First Submitted: September 30, 2024
• First Submitted That Met QC Criteria: October 3, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 3, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Metabolic syndrome; Dyslipidemia; Weight gain
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID 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