Integrase Strand Transfer Inhibitors Are Associated With Incident Diabetes Mellitus in People With Human Immunodeficiency Virus.
Jane A O'Halloran, John Sahrmann, Luis Parra-Rodriguez...
https://pubmed.ncbi.nlm.nih.gov/35521785Actively Recruiting
Phase 4
Age: 18Years - 80Years
MALE
ID06602622
Change in Body Weight and BMI in People with HIV Who Maintain a Second-generation Integrase Inhibitor Compared to Those Switching to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate at 48 Weeks
Led by Instituto Mexicano del Seguro Social · Updated on 2024-09-19
108
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate changes in body weight and body mass index (BMI) among people with HIV (PWH) who have experienced metabolic syndrome after at least 36 months on antiretroviral therapy (ART) using second-generation integrase inhibitors. Participants must have gained at least 10% of their body weight after starting ART, with a BMI of 25 kg/m2 or higher and body fat over 20%. The study focuses on whether switching to a different ART regimen affects weight and metabolic health over 48 weeks. Participants will be randomly assigned by a mobile application to either continue their current integrase inhibitor-based ART regimen or switch to a regimen containing doravirine, lamivudine, and tenofovir disoproxil fumarate (DOR/3TC/TDF). Both treatment groups will take one tablet daily for 48 weeks. Medical visits will occur at 1, 3, 6, 9, and 12 months, with laboratory tests to monitor fats, blood sugar, liver and kidney function, and HIV control. Self-assessment scales for neuropsychiatric symptoms like depression, anxiety, and insomnia, as well as treatment satisfaction, will also be completed. Participants will undergo detailed medical interviews, physical measurements including body composition, and regular blood and urine tests throughout the study. Questionnaires will evaluate mental health and treatment satisfaction at multiple time points. The main outcome is the change in body weight and BMI after 48 weeks. Secondary outcomes include safety monitoring, neuropsychiatric effects, lipid profile changes, body composition, cardiovascular risk, and kidney function. Participants can withdraw at any time without affecting their usual HIV care.
CONDITIONS
Brief Title
Change in Body Weight and BMI in PWH with DOR/3TC/TDF Compared with INSTI
Who Can Participate
Age: 18Years - 80Years
MALE
Eligibility Criteria
You may qualify if you...
- Male aged 18 to 80 years
- Virologically suppressed for at least 48 weeks prior to study entry
- On Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF), Dolutegravir/Lamivudine/Abacavir (DTG/3TC/ABC), or Dolutegravir/Tenofovir Disoproxil Fumarate/Emtricitabine (DTG+TDF/FTC) regimen for at least 48 weeks
- Body mass index (BMI) of 25 kg/m2 or higher at screening
- Unintentional weight gain of more than 10% from baseline within 1-3 years of starting integrase inhibitor ART
- Body fat percentage greater than 20%
- No plans to add or change medications associated with significant weight changes during the study
- Stable dose of antipsychotics, antidepressants, anticonvulsants/mood stabilizers, and thyroid hormones for at least 12 weeks prior
- Stable dose of antidiabetic drugs known to cause weight loss for at least 24 weeks prior
- Agree to adhere to assigned ART during the study
- HIV-1 RNA less than 50 copies/mL within 45 days prior to study entry
- Glomerular filtration rate (GFR) by CDK-EPI 60 mL/min or higher
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than 90 IU/L
- Thyroid profile (TSH, free T3, free T4) prior to study entry
- Serum and urinary electrolytes and cystatin C prior to study entry
You will not qualify if you...
- Loss of social security
- Allergy to any components of ART
- Withdrawal of informed consent
- Acquiring hepatitis B or C virus during follow-up
- HIV-1 RNA greater than 200 copies/mL in two consecutive tests after prior suppression
- Starting or stopping certain antipsychotic, antidepressant, anticonvulsant, or thyroid medications associated with weight changes during the study
- Changing dose or stopping antidiabetic drugs causing weight loss during the study
- Planning or having undergone bariatric surgery
- Starting significant dietary changes advised by a nutritionist
- Starting or increasing physical exercise beyond 250 minutes per week of moderate to intense activity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Treatment
Duration - 48 weeks
Participants receive either their current second-generation integrase inhibitor regimen or switch to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate, taking one tablet daily for up to 48 weeks.
Visits at 4 weeks, 12 weeks, 24 weeks, and 48 weeks for laboratory tests and questionnaires
Follow-up
Duration - Up to 12 months
Participants continue monitoring with laboratory tests for CD4+, HIV-1 RNA, cystatin C, and urinary electrolytes at 6 months and 12 months after entering the study.
2 visits at 6 and 12 months post-entry
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
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Research Team
A
Ana L Cano, Postgraduate
J
José A Mata, Doctor
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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Published Research Related To This Trial
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate is Non-inferior to Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment-naive Adults With Human Immunodeficiency Virus-1 Infection: Week 48 Results of the DRIVE-AHEAD Trial.
Chloe Orkin, Kathleen E Squires, Jean-Michel Molina...
https://pubmed.ncbi.nlm.nih.gov/30184165Improvement in insulin sensitivity after switching from an integrase inhibitor-based regimen to doravirine/tenofovir disoproxil fumarate/lamivudine in people with significant weight gain.
Leonardo Calza, Maddalena Giglia, Vincenzo Colangeli...
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Chloe Orkin, Richard Elion, Melanie Thompson...
https://pubmed.ncbi.nlm.nih.gov/33048879Doravirine versus ritonavir-boosted darunavir in antiretroviral-naive adults with HIV-1 (DRIVE-FORWARD): 48-week results of a randomised, double-blind, phase 3, non-inferiority trial.
Jean-Michel Molina, Kathleen Squires, Paul E Sax...
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Sara H Bares, Xingye Wu, Katherine Tassiopoulos...
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Simiso Sokhela, Willem D F Venter, Bronwyn Bosch...
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Kishore M Gadde, Corby K Martin, Hans-Rudolf Berthoud...
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Allison Ross Eckard, Grace A McComsey
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Robert S Hogg, Oghenowede Eyawo, Alexandra B Collins...
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