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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm: | Experimental | they will take 1 tablet (50 mg BIC + 200 mg FTC + 25 mg TAF), orally, once a day, from the moment of randomization. |
|
| Comparator arm | Active Comparator | they will take 1 tablet of 50 mg of DTG orally, once a day + 1 tablet of 300 mg of 3TC orally, once a day, from the randomization moment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual Therapy | Drug | DTG + 3TC |
| |
| Triple therapy |
| Measure | Description | Time Frame |
|---|---|---|
| sCD14 | Changes in sCD14 concentration | Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in PCR-us | Inflammation (IL-6 signaling pathways): | Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96 |
| Changes in sCD163 | Monocyte / macrophage activation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Santiago Moreno, MD | Hospital Univ. Ramón y Cajal | Principal Investigator |
| Sergio Serrano, MD | Hospital Univ. Ramón y Cajal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital San Pedro | Logroño | La Rioja | 26006 | Spain | ||
| Hospital Universitario Príncipe de Asturias |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39055703 | Derived | Saborido-Alconchel A, Serna-Gallego A, Trujillo-Rodriguez M, Munoz-Muela E, Alvarez-Rios AI, Lozano C, Llaves-Flores S, Espinosa N, Roca-Oporto C, Herrero M, Sotomayor C, Gutierrez-Valencia A, Lopez-Cortes LF. Long-term effects on immunological, inflammatory markers, and HIV-1 reservoir after switching to a two-drug versus maintaining a three-drug regimen based on integrase inhibitors. Front Immunol. 2024 Jul 11;15:1423734. doi: 10.3389/fimmu.2024.1423734. eCollection 2024. |
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Comparator: the patient will continue taking the dual therapy. Experimental: the patient Will beging to take triple therapy.
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| Drug |
BIC / FTC / TAF |
|
| Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96 |
| Changes in quinurenine / tryptophan ratio | IDO-1 induction | Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96 |
| Changes in Dimer D | Coagulation | Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96 |
| Changes in CD4/CD8 ratio | Inmunoactivation | Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96 |
| Changes in CD4+ | Throughout all the study, an average of 100 weeks |
| Changes in viral suppression rates | 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. | Throughout all the study, an average of 100 weeks |
| Longitudinal trajectories of CD4/CD8 ratio | Throughout all the study, an average of 100 weeks |
| Alcalá de Henares |
| Madrid |
| 28002 |
| Spain |
| Hospital Universitario Puerta de Hierro | Majadahonda | Madrid | 28222 | Spain |
| Hospital de Bellvitge | Barcelona | Spain |
| Hospital Univ. Vall D'Hebron | Barcelona | Spain |
| H. General Universitario Guadalajara | Guadalajara | Spain |
| Hospital Universitario Infanta Leonor | Madrid | 28050 | Spain |
| Hospital Clínico San Carlos | Madrid | Spain |
| Hospital Fundación Jimenez Diaz | Madrid | Spain |
| Hospital Univ. La Paz | Madrid | Spain |
| Hospital Univ. Ramón y Cajal | Madrid | Spain |
| Hospital Virgen de las Nieves | Malá | Spain |
| Hospital Virgen de la Victoria | Málaga | Spain |
| H. General Universitario Reina Sofía | Murcia | 30003 | Spain |
| Hospital Univ. Virgen del Rocio | Seville | Spain |
| H. Universitario y Politécnico La Fe | Valencia | 46026 | Spain |
| Hospital Univ. Clínico de Valencia | Valencia | Spain |
| Hospital Univ. Lozano Blesa | Zaragoza | Spain |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000080903 | Dual Anti-Platelet Therapy |
| ID | Term |
|---|---|
| D004359 | Drug Therapy, Combination |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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