Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06629480
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
Incidence of Metabolic Syndrome in People Living With HIV Without ExperienCe to ART Who Start DoLutegravir Based-Regimen Compared With BictegrAvir Based-RegimeN
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MICTLAN
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 BICFTCTAF or DTG3TCABC 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
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 conductedfrom 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 BICFTCTAF with DTG3TCABC in patients with HIV type 1 HIV-1 infection starting ARTStudy 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None