HIV Infections
Conditions
Brief summary
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)
Interventions
DRUGDual Therapy
DTG + 3TC
DRUGTriple therapy
BIC / FTC / TAF
Sponsors
Fundacion SEIMC-GESIDA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Comparator: the patient will continue taking the dual therapy. Experimental: the patient Will beging to take triple therapy.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women ≥ 18 years * Confirmed and documented diagnosis of HIV-1 infection * Virological suppression of more than 48 weeks (confirmed with HIV RNA \<50 copies / ml). The determination of the CV of a routine prior analysis of ≤ 12 weeks prior to signature of consent. * ART in stable dual therapy (\> 48 weeks) with DTG + 3TC * Signed informed consent * Negative pregnancy test in urine or blood
Exclusion criteria
* Inability to obtain written informed consent to participate in the study * Pregnant or breastfeeding women or those who intend to become pregnant during the study period and do not undertake to use proven contraceptive methods. * Any suspicion or confirmation of resistance to TAF, 3TC, FTC, DTG or BIC. In case of have a study of baseline resistance mutations prior to the start of ART has to rule out resistance to investigational drugs. * Patients with hypersensitivity to any excipient used with TAF, FTC, DTG or BIC * Any chronic autoimmune or inflammatory disease * Use of immunomodulatory or immunosuppressive agents, including steroids Chronic treatment with aspirin, statins and other anti-inflammatory agents * Any acute infection in the last 2 months * Estimated glomerular filtration rate (TFGe) \<30 mg / ml / m2 measured by any of the formulas available. The determination of the TFGe of a previous routine analysis of ≤ 12 weeks prior to signing the consent is allowed * Contraindication for the use of TAF * Clinical condition of the patient in rapid deterioration or the investigator considers that there is no reasonable hope that the patient will finish the study * Simultaneous participation in another clinical trial or research study that requires the need of treatment with other drugs outside the study or interfere with the visits of the same. * Any situation that, in the opinion of the investigator, may interfere with the patient's ability to meet the treatment schedule and protocol evaluations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| sCD14 | Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96 | Changes in sCD14 concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in sCD163 | Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96 | Monocyte / macrophage activation |
| Changes in quinurenine / tryptophan ratio | Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96 | IDO-1 induction |
| Changes in Dimer D | Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96 | Coagulation |
| Changes in CD4/CD8 ratio | Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96 | Inmunoactivation |
| Changes in PCR-us | Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96 | Inflammation (IL-6 signaling pathways): |
| Changes in viral suppression rates | Throughout all the study, an average of 100 weeks | — |
| Longitudinal trajectories of plasma biomarkers | Throughout all the study, an average of 100 weeks | 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. |
| Longitudinal trajectories of CD4/CD8 ratio | Throughout all the study, an average of 100 weeks | — |
| Changes in CD4+ | Throughout all the study, an average of 100 weeks | — |
Countries
Spain
Outcome results
None listed