Status:
RECRUITING
Change in Body Weight and BMI in PWH with DOR/3TC/TDF Compared with INSTI
Lead Sponsor:
Instituto Mexicano del Seguro Social
Conditions:
HIV
HIV Associate Weight Loss
Eligibility:
MALE
18-80 years
Phase:
PHASE4
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 (BIC/TAF/FT...
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 determin...
Eligibility Criteria
Inclusion
- Virologically suppressed for at least 48 weeks prior to study entry
- Coming from a regimen containing Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF), Dolutegravir/Lamivudine/Abacavir (DTG/3TC/ABC), or, Dolutegravir/Tenofovir Disoproxil Fumarate/Emtricitabine (DTG+TDF/FTC) with no known failures to integrase inhibitors for al least 48 weeks.
- BMI ≥25 kg/m2 at screening and
- Unintentional weight gain of \>10% from baseline (prior to INSTI initiation) within 1-3 years of starting INSTI ART, with no other apparent medical reason to explain the weight gain (concomitant medication use, Cushing's disease, recent prolonged hospitalization, etc.), in the opinion of the site investigator.
- Body fat percentage \>20%
- No indication or plans to add or change medications associated with significant weight change during the study period.
- Participants currently receiving antipsychotics, antidepressants, anticonvulsants/mood stabilizers, and thyroid replacement hormones without dose modifications for at least 12 weeks prior to randomization
- Participants currently receiving antidiabetics known to cause weight loss and without dose modifications for at least 24 weeks prior to randomization (GLP-1 receptor agonists, SGLT-2 inhibitors, insulin, metformin).
- Agree to adhere to assigned ART during the study period
- HIV-1 RNA screening \<50 copies/mL performed within 45 days prior to study entry.
- GFR by CDK-EPI ≥60 mL/min
- Alanine aminotransferase (ALT) and asparatate aminotransferase (AST) \< 90 IU/L
- Thyroid profile (TSH, free T3 and free T4) prior to entering the study
- Serum and urinary electrolytes, cystatin C, prior to entering the study
Exclusion
- Loss of social security
- Allergy to any of the components of ART, previously unknown.
- Withdrawal of informed consent
- Acquiring HBV and/or HCV infection during follow-up.
- HIV-1 RNA \>200 copies/mL in 2 consecutive determinations after having achieved virological suppression.
- Early initiation or discontinuation of any of the following drugs after entering the study: antipsychotics (clozapine, olanzapine, risperidone); antidepressants (tricyclic antidepressants, selective serotonin reuptake inhibitors) monoamine oxidase inhibitors, associated with weight gain; anticonvulsants/mood stabilizers (lithium, valproic acid) or associated with weight loss (topiramate); thyroid replacement hormones;
- Change in dose or discontinuation of antidiabetic drugs that cause weight loss (GLP-1 receptor agonists, SGLT-2 inhibitors, insulin, metformin), after entering the study.
- Planning to undergo or having undergone bariatric surgery.
- Initiating significant dietary changes, advised by a nutritionist according to what was reported by the participant
- Initiating or increasing physical exercise or enrolling in a structured weight loss regimen: \<250 minutes/week of moderate to intense activity
Key Trial Info
Start Date :
August 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 14 2025
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT06602622
Start Date
August 14 2024
End Date
November 14 2025
Last Update
September 19 2024
Active Locations (2)
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1
Hospital de infectología, Centro Médico Nacional La Raza
Mexico City, Azcapotzalco, Mexico, 02990
2
Hospital de infectología, Centro Médico Nacional La Raza
Mexico City, Azcapotzalco, Mexico, 02990