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Study identifier: NCT06602622 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Change in Body Weight and BMI in PWH with DOR/3TC/TDF Compared with INSTI

Condition: HIV · HIV Associate Weight Loss · HIV-1 Infection  ·  Sponsor: Instituto Mexicano del Seguro Social

PhasePhase 4
Planned participants108
Who can joinMale, 18 Years to 80 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Ana L Cano, Postgraduate  ·  2291243665  ·  ana.knodiaz@gmail.com

José A Mata, Doctor  ·  5530379053  ·  jamatamarin@gmail.com

Always discuss trial participation with your own doctor first.

Locations (2)

Hospital de infectología, Centro Médico Nacional La RazaMexico City, Azcapotzalco, MexicoRecruiting
Hospital de infectología, Centro Médico Nacional La RazaMexico City, Azcapotzalco, MexicoRecruiting

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Source record: clinicaltrials.gov/study/NCT06602622