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.
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 …
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