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

NCT06629480 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 378

Last updated 2024-10-08

No results posted yet for this study

Summary

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.

Conditions

  • Antiretroviral Treatment
  • HIV Infection
  • Metabolic Cardiovascular Syndrome

Interventions

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.

Sponsors & Collaborators

  • Instituto Mexicano del Seguro Social

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-25
Primary Completion
2024-02-24
Completion
2024-02-28

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06629480 on ClinicalTrials.gov