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NCT06629480Completed

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

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)

Source: ClinicalTrials.gov · Last updated 8 Oct 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
378 (actual)
First submitted
30 Sept 2024
Start date
25 Jun 2021
Primary completion date
24 Feb 2024
Lead sponsor
Instituto Mexicano del Seguro Social
Diseases
HIV
NCT number
NCT06629480

What you commit to

  • Study type: Interventional
  • Participants enrolled: 378
  • From 25 Jun 2021 to the primary completion date, 24 Feb 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Comorbidities or prescription of drugs associated with weight gain or weight loss

Other illness

  • Metabolic Syndrome
  • Current treatment for tuberculosis.

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital de Infectología, "La Raza" National Medical Center
Coordinator of this site? Confirm its status
Mexico CityMexicoUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.