242 patients (121 patients in each of the two treatment arms) will be included with a confirmed diagnosis of HIV-1 infection and with a stable antiretroviral treatment during more than 48 weeks with dual therapy (DTG + 3TC)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
141
DTG + 3TC
BIC / FTC / TAF
Hospital San Pedro
Logroño, La Rioja, Spain
Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Madrid, Spain
sCD14
Changes in sCD14 concentration
Time frame: Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
Changes in PCR-us
Inflammation (IL-6 signaling pathways):
Time frame: Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
Changes in sCD163
Monocyte / macrophage activation
Time frame: Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
Changes in quinurenine / tryptophan ratio
IDO-1 induction
Time frame: Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
Changes in Dimer D
Coagulation
Time frame: Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
Changes in CD4/CD8 ratio
Inmunoactivation
Time frame: Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
Changes in CD4+
Time frame: Throughout all the study, an average of 100 weeks
Changes in viral suppression rates
Time frame: Throughout all the study, an average of 100 weeks
Longitudinal trajectories of plasma biomarkers
The differences in the trajectories of soluble inflammatory markers by comparing the slopes of each biomarker between treatment arms. Longitudinal changes in each biomarker will be compared using linear or non-linear mixed models with random intercepts, depending on the normality of the data.
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Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
Hospital de Bellvitge
Barcelona, Spain
Hospital Univ. Vall D'Hebron
Barcelona, Spain
H. General Universitario Guadalajara
Guadalajara, Spain
Hospital Universitario Infanta Leonor
Madrid, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Fundación Jimenez Diaz
Madrid, Spain
Hospital Univ. La Paz
Madrid, Spain
...and 8 more locations
Time frame: Throughout all the study, an average of 100 weeks
Longitudinal trajectories of CD4/CD8 ratio
Time frame: Throughout all the study, an average of 100 weeks