Actively Recruiting
Change in Body Weight and BMI in PWH with DOR/3TC/TDF Compared with INSTI
Led by Instituto Mexicano del Seguro Social · Updated on 2024-09-19
108
Participants Needed
2
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 (BIC/TAF/FTC, DTG/ABC/3Tc or DTG+TDF/FTC) who have gained at least 10% of their total body weight after starting ART, with a body mass index ≥25 kg/m2 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 doravirine/lamivudine/disoproxil 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 it.The aim of the study is to observe whether there is weight loss with the change in HIV treatment.
CONDITIONS
Official Title
Change in Body Weight and BMI in PWH with DOR/3TC/TDF Compared with INSTI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Virologically suppressed for at least 48 weeks prior to study entry
- On a regimen containing BIC/FTC/TAF, DTG/3TC/ABC, or DTG+TDF/FTC with no known integrase inhibitor failures for at least 48 weeks
- BMI of 25 kg/m2 or higher at screening
- Unintentional weight gain of more than 10% from baseline within 1-3 years of starting INSTI ART without other medical causes
- Body fat percentage greater than 20%
- No planned changes to medications associated with significant weight change during the study
- Stable doses of antipsychotics, antidepressants, anticonvulsants/mood stabilizers, and thyroid hormones for at least 12 weeks prior
- Stable doses of antidiabetic drugs known to cause weight loss for at least 24 weeks prior
- Agree to follow assigned ART regimen during the study
- HIV-1 RNA less than 50 copies/mL within 45 days before study entry
- Glomerular filtration rate (GFR) of 60 mL/min or higher
- ALT and AST less than 90 IU/L
- Normal thyroid profile prior to study entry
- Normal serum and urinary electrolytes and cystatin C prior to study entry
You will not qualify if you...
- Loss of social security
- Allergy to any ART components
- Withdrawal of informed consent
- New HBV or HCV infection during follow-up
- HIV-1 RNA greater than 200 copies/mL in two consecutive tests after suppression
- Starting or stopping certain antipsychotics, antidepressants, anticonvulsants, or thyroid hormones after study entry
- Changing doses or stopping antidiabetic drugs that cause weight loss after study entry
- Planning or having bariatric surgery
- Starting significant dietary changes advised by a nutritionist
- Starting or increasing physical exercise beyond 250 minutes/week of moderate to intense activity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Hospital de infectología, Centro Médico Nacional La Raza
Mexico City, Azcapotzalco, Mexico, 02990
Actively Recruiting
2
Hospital de infectología, Centro Médico Nacional La Raza
Mexico City, Azcapotzalco, Mexico, 02990
Actively Recruiting
Research Team
A
Ana L Cano, Postgraduate
CONTACT
J
José A Mata, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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