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

NCT06629480 | Completed

• 1 other identifier: R-2021-3502-084
• Study Type: interventional
• Target: 378
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Weight gain; Metabolic syndrome; Dyslipidemia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

BIC/TAF/FTC

ACTIVE COMPARATOR

Drug: Bictegravir

DTG/ABC/3TC

ACTIVE COMPARATOR

Drug: Bictegravir

Interventions

Bictegravir DRUG

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.

BIC/TAF/FTC; DTG/ABC/3TC

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

Hospital de Infectología, "La Raza" National Medical Center

Mexico City, 02990, Mexico

Location

MeSH Terms

Conditions

HIV Infections; Metabolic Syndrome; Weight Gain; Dyslipidemias

Interventions

bictegravir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lipid Metabolism Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 8, 2024
• Study Start: June 25, 2021
• Primary Completion: February 24, 2024
• Study Completion: February 28, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

ME (1)