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

Recruiting Phase 4 Interventional Study
HIV HIV Associate Weight Loss HIV-1 Infection Integrase Inhibitors, HIV; HIV PROTEASE INHIB Weight Change Weight Loss
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 80
Sex
Male
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
108 (estimated)
Sponsor
Instituto Mexicano del Seguro Social · Government
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About This Trial
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 participat…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Virologically suppressed for at least 48 weeks prior to study entry 2. Coming from a regimen containing Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF), Dolutegravir/Lamivudine/Abacavir (DTG/3TC/ABC), or, Dolutegravir/Tenofovir Disoproxil Fumarate/Emtricitabine …
Contacts

Ana L Cano, Postgraduate

2291243665

ana.knodiaz@gmail.com

CONTACT

José A Mata, Doctor

5530379053

jamatamarin@gmail.com

CONTACT