Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06602622
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
Change in Body Weight and BMI in PWH with DOR3TCTDF Compared with INSTI
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Change in Body Weight and BMI in PWH Virologically Suppressed Who Maintain a Second-generation INSTI Regimen Compared to Those Who Switch to DOR3TCTDF At 48 Weeks
Status:
RECRUITING
Status Verified Date:
2024-09
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:
TLATOANI
Brief Summary:
Patients who developed metabolic syndrome after initiation of HIV treatment or with antiretroviral therapy ART for at least 36 months treated with second generation integrase inhibitors BICTAFFTC DTGABC3Tc or DTGTDFFTC who have gained at least 10 of their total body weight after starting ART with a body mass index 25 kgm2 and body fat greater than 20 will be eligible to participate in this clinical trial If they decide to participate they will sign an informed consent After this a mobile application will randomly decide whether the participant will continue with their ART regimen or switch to another ART listed in the guidelines as one of the main lines of treatment containing doravirinelamivudinedisoproxil fumarate tenofovir Medical visits will be at 1 month 3 months 6 months 9 months and 12 months after get in to this protocol with laboratory studies that evaluate fats blood sugar liver function kidney function and test for HIV control in addition each visit will be given self-fillable scales to evaluate neuropsychiatric disorders such as depression anxiety insomnia satisfaction with treatment or symptoms associated with itThe aim of the study is to observe whether there is weight loss with the change in HIV treatment
Detailed Description:
Open-label randomized clinical trial conducted at the infectious disease hospital La Raza National Medical Center Mexico City from July 2024 to November 2025
The aim of the study is to determine the percentage change in body weight and BMI in virologically suppressed PWH maintaining a second-generation INSTI BICTAFFTC DTGABC3TC or DTGTDFFTC regimen compared with those switching to DOR3TCTDF at 48 weeks post-switch
PWH who are on a second-generation INSTI regimen who are virologically suppressed HIV-1 RNA minor to 50 copiesmL and have gained 10 of their body weight compared to their weight before starting ART BMI 25 kgm2 and body fat greater than 20 will be identified and invited to participate
A medical interview will be conducted to assess clinical characteristics comorbidities of the study subject new drugs changes in doses or suspensions as well as plans by their other physicians for changes in the same diet frequency and intensity of exercise Once the preliminary information has been obtained it will be established whether the patient is a candidate to take part in the study and will be invited to participate voluntarily The project and the probable results benefits and risks of participating will be explained in detail and in detail If they agree to participate informed consent will be obtained from the principal investigator or associate researchers during the medical visit where weight gain and BMI are identified for authorization to take clinical exams anthropometric measurements these will be carried out by the principal investigator or associates A response will be obtained during the same medical visit with free decision to continue or withdraw from the study at the time deemed appropriate during the study period without this affecting your medical care at the HIV clinic Annex 1 Patients who accept will be asked again for HIV-1 RNA CD4 complete blood count lipid profile complete liver enzymes cystatin C and urinary electrolytes within 45 days prior to randomization and if they meet the inclusion criteria through simple randomization and with the randomizer for clinical trial application the principal investigator will randomize them into the group of maintaining the previous regimen with second-generation INSTI or changing the regimen to DOR3TCTDF and in order to maintain privacy a folio number will be assigned at the time of recruitment
Weight measurements will be taken with a FitScan segmental body composition monitor BC-545F scale height in centimeters body mass index BMI with the formula weight kgheight m2 body composition fat in water in muscle in kg bone in kg with a FitScan segmental body composition monitor BC-545F equipment waist and hip measurements with a measuring tape in cm
Laboratory studies will include complete blood count complete blood chemistry with glucose creatinine complete lipid profile and liver function tests after randomization at 4 weeks 12 weeks 24 weeks and 48 weeks post-switch CD4 HIV-1 RNA Cystatin C and urinary electrolytes will be determined prior to randomization at 6 months and 12 months after entering the study Comparisons will be made between measurements taken prior to entering the study at 24 and 48 weeks after entering the study
In case of elevated AST andor ALT ampampampampgt90 IUL serologies will be requested to rule out HBV and HCV
The PSQI ISI HADS-A and HADS-D questionnaires will be used to assess anxiety depression and sleep quality in addition the HIVTSQ questionnaire will be used to assess treatment satisfaction at weeks 4 12 24 and 48 weeks after randomization and HIV Symptoms Distress Module HIV-SDM
The change in weight and BMI at 48 weeks will be defined as the difference between the weight and BMI prior to randomization compared to the results at 48 weeks weight will be expressed in kg percentages and BMI in kgm2
The sampling was simple random participation in the study was offered to all Mexican patients living with HIV who have gained 10 of body weight and BMI 25 from a regimen with second-generation integrase inhibitor BICTAFFTC or DTGABC3TC
Sample size per group 54 participants per group Calculated based on the expected change after switching from INSTI to a regimen with DORTDF3TC with estimated losses of 20 108 participants in total
Kolmogorov-Smirnoff test will be used to identify distribution of data and to express central tendency measures medians with interquartile ranges and percentages accordingly Data will be compared using the Mann-Whitney U test Qualitative data will be analyzed using the x2 or Fishers exact test as appropriate Subsequently data will be analyzed by groups at 12 24 36 and 48 weeks using the Wilcoxon test A P value 005 with a 95 confidence interval will be considered statistically significant
The aim of the study is to determine the percentage change in body weight and BMI in virologically suppressed PWH maintaining a second-generation INSTI BICTAFFTC DTGABC3TC or DTGTDFFTC regimen compared with those switching to DOR3TCTDF at 48 weeks post-switch
PWH who are on a second-generation INSTI regimen who are virologically suppressed HIV-1 RNA minor to 50 copiesmL and have gained 10 of their body weight compared to their weight before starting ART BMI 25 kgm2 and body fat greater than 20 will be identified and invited to participate
A medical interview will be conducted to assess clinical characteristics comorbidities of the study subject new drugs changes in doses or suspensions as well as plans by their other physicians for changes in the same diet frequency and intensity of exercise Once the preliminary information has been obtained it will be established whether the patient is a candidate to take part in the study and will be invited to participate voluntarily The project and the probable results benefits and risks of participating will be explained in detail and in detail If they agree to participate informed consent will be obtained from the principal investigator or associate researchers during the medical visit where weight gain and BMI are identified for authorization to take clinical exams anthropometric measurements these will be carried out by the principal investigator or associates A response will be obtained during the same medical visit with free decision to continue or withdraw from the study at the time deemed appropriate during the study period without this affecting your medical care at the HIV clinic Annex 1 Patients who accept will be asked again for HIV-1 RNA CD4 complete blood count lipid profile complete liver enzymes cystatin C and urinary electrolytes within 45 days prior to randomization and if they meet the inclusion criteria through simple randomization and with the randomizer for clinical trial application the principal investigator will randomize them into the group of maintaining the previous regimen with second-generation INSTI or changing the regimen to DOR3TCTDF and in order to maintain privacy a folio number will be assigned at the time of recruitment
Weight measurements will be taken with a FitScan segmental body composition monitor BC-545F scale height in centimeters body mass index BMI with the formula weight kgheight m2 body composition fat in water in muscle in kg bone in kg with a FitScan segmental body composition monitor BC-545F equipment waist and hip measurements with a measuring tape in cm
Laboratory studies will include complete blood count complete blood chemistry with glucose creatinine complete lipid profile and liver function tests after randomization at 4 weeks 12 weeks 24 weeks and 48 weeks post-switch CD4 HIV-1 RNA Cystatin C and urinary electrolytes will be determined prior to randomization at 6 months and 12 months after entering the study Comparisons will be made between measurements taken prior to entering the study at 24 and 48 weeks after entering the study
In case of elevated AST andor ALT ampampampampgt90 IUL serologies will be requested to rule out HBV and HCV
The PSQI ISI HADS-A and HADS-D questionnaires will be used to assess anxiety depression and sleep quality in addition the HIVTSQ questionnaire will be used to assess treatment satisfaction at weeks 4 12 24 and 48 weeks after randomization and HIV Symptoms Distress Module HIV-SDM
The change in weight and BMI at 48 weeks will be defined as the difference between the weight and BMI prior to randomization compared to the results at 48 weeks weight will be expressed in kg percentages and BMI in kgm2
The sampling was simple random participation in the study was offered to all Mexican patients living with HIV who have gained 10 of body weight and BMI 25 from a regimen with second-generation integrase inhibitor BICTAFFTC or DTGABC3TC
Sample size per group 54 participants per group Calculated based on the expected change after switching from INSTI to a regimen with DORTDF3TC with estimated losses of 20 108 participants in total
Kolmogorov-Smirnoff test will be used to identify distribution of data and to express central tendency measures medians with interquartile ranges and percentages accordingly Data will be compared using the Mann-Whitney U test Qualitative data will be analyzed using the x2 or Fishers exact test as appropriate Subsequently data will be analyzed by groups at 12 24 36 and 48 weeks using the Wilcoxon test A P value 005 with a 95 confidence interval will be considered statistically significant
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