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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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The goal of this study is to analyze in treatment-naïve HIV patients the antiviral activity, using a test and treat strategy, in real life of BIC/FTC/TAF. Secondary, this study aims to evaluate outcomes for implementation of the evidence based test and treat strategy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group | Experimental | HIV-1 infected adults, ART-naive subjects, who start BIC/FTC/TAF using test and treat strategy recruited at infectious diseases units from various Spanish public healthcare centers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIC/FTC/TAF | Drug | TEST and TREAT strategy: Study group will start the intervention at the first visit with their healthcare provider. |
|
| Measure | Description | Time Frame |
|---|---|---|
| HIV-1 RNA in plasma (week 24) | copies of HIV RNA -1 in plasma at week 24 | 24 week |
| HIV-1 RNA in plasma week 48 | copies of HIV RNA -1 in plasma at week 48 | 48 week |
| Measure | Description | Time Frame |
|---|---|---|
| Medicaction adherence | proportion of pills taken, self-reported | 48 week |
| Retention in care | Subjects completing all study visits | 48 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen de Las Nieves | Granada | Andalusia | 18008 | Spain | ||
| H JEREZ |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40982450 | Derived | Sequera-Arquelladas S, Vivancos MJ, Vinuesa D, Collado A, Santos IL, Sorni P, Cabello-Clotet N, Montero M, Font CR, Terron A, Galindo MJ, Martinez O, Ryan P, Omar-Mohamed M, Albendin-Iglesias H, Javier R, Romero A, Vallecillos CG, Calleja MA, Hidalgo-Tenorio C. Impact of bictegravir/emtricitabine/tenofovir alafenamide on health-related quality of life and economic outcomes in HIV care: Substudy of the BIC-NOW clinical trial. PLoS One. 2025 Sep 22;20(9):e0323167. doi: 10.1371/journal.pone.0323167. eCollection 2025. | |
| 38574873 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 8, 2024 | |
| Reset | Oct 4, 2024 |
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| Quality of Life patient reported outcomes EQ-5D | effect of test and treat strategy on health related quality of life and HIV-related symptoms to treatment-naïve HIV patients through PROs EQ-5D (Five dimensions descriptive system of quality of live from EuroQoL) | 48 week |
| Quality of Life patient reported outcomes dichotomized HIV-Symptoms Index | effect of test and treat strategy on health related quality of life and HIV-related symptoms to treatment-naïve HIV patients through PROs dichotomized HIV-SI | 48 week |
| Feasibility of test and treat strategy | Time to full enrolment of 139 eligible treatment-naïve HIV patients at 22 public healthcare centers in Spain and by physicians using screening data reports | 48 week |
| demographics and baseline characteristics | Proportion of subjects by patient subgroup (e.g. by gender, age…) with plasma HIV-1 RNA <50 copies/mL at week 48 using FDA Snapshot algorithm | 48 week |
| viral resistance | Incidence of treatment-emergent genotypic or/and phenotypic resistence to any ART | 48 week |
| antiviral activity | Time to viral suppression and absolute changes from baseline in lymphocyte count at week 48 | 48 week |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Incidence and severity of adverse events and laboratory abnormalities | 48 week |
| Jerez de la Frontera |
| Cádiz |
| Spain |
| Hospital Universitario Torrecárdenas | Almería | Spain |
| Hospital Universitario Puerto Real, INIBICA, | Cadiz | Spain |
| Hospital Campus de la Salud | Granada | 18014 | Spain |
| Complejo Hospitalario de Jaén, | Jaén | Spain |
| Hospital Clínico San Carlos, Complutense University, CIBERINFEC ISCIII, Madrid, Spain | Madrid | Spain |
| Hu Infanta Leonor | Madrid | Spain |
| Hu La Princesa | Madrid | Spain |
| Ramon Y Cajal | Madrid | Spain |
| Hospital General Universitario Santa Lucía | Murcia | Spain |
| Hospital Universitario Virgen de la Arrixaca, IMIB, | Murcia | Spain |
| Hospital de Son Llàtzer | Palma de Mallorca | Spain |
| Hospital Clínico Universitario de Valencia | Valencia | Spain |
| HU la Fé | Valencia | Spain |
| Derived |
| Hidalgo-Tenorio C, Sequera S, Vivancos MJ, Vinuesa D, Collado A, Santos IL, Sorni P, Cabello-Clotet N, Montero M, Font CR, Terron A, Galindo MJ, Martinez O, Ryan P, Omar-Mohamed M, Albendin-Iglesias H, Javier R, Ruz MAL, Romero A, Garcia-Vallecillos C. Bictegravir/emtricitabine/tenofovir alafenamide as first-line treatment in naive HIV patients in a rapid-initiation model of care: BIC-NOW clinical trial. Int J Antimicrob Agents. 2024 Jun;63(6):107164. doi: 10.1016/j.ijantimicag.2024.107164. Epub 2024 Apr 2. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 8, 2024 | Oct 4, 2024 |
| 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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