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

PHASE4RecruitingINTERVENTIONAL
Enrollment

108

Participants

Timeline

Start Date

August 14, 2024

Primary Completion Date

November 14, 2025

Study Completion Date

November 14, 2025

Conditions
HIVHIV Associate Weight LossHIV-1 InfectionIntegrase Inhibitors, HIV; HIV PROTEASE INHIBWeight ChangeWeight Loss
Interventions
DRUG

Integrase inhibitor

Second generation integrase inhibitor 1) Bictegravir 50 mg/ alafenamide tenofovir 25 mg/ emtricitabine 200 mg (BIC/TAF/FTC); 2) Dolutegravir 50 mg/ abacavir 600 mg/ lamivudine 300 mg (DTG/ABC/3TC); 3) DTG 50mg+TDF 300mg/FTC 200mg (DTG+TDF/FTC) Each will be prescribed one tablet every day during 48 weeks

DRUG

Doravirine + tenofovir DF + lamivudine

Individuals who meet the selection criteria will be randomized to maintain their same regimen with second-generation integrase inhibitors or switch to DOR/TDF/3TC 100/ 300/300 mg It will be prescribed one tablet every day during 48 weeks

Trial Locations (2)

02990

RECRUITING

Hospital de infectología, Centro Médico Nacional La Raza, Mexico City

RECRUITING

Hospital de infectología, Centro Médico Nacional La Raza, Mexico City

All Listed Sponsors
lead

Instituto Mexicano del Seguro Social

OTHER_GOV

NCT06602622 - Change in Body Weight and BMI in PWH with DOR/3TC/TDF Compared with INSTI | Biotech Hunter | Biotech Hunter