Study of Bictegravir/Emtricitavine/Tenofovir Alafenamide in HIV-1 Infected naïve Patients Using Test and Treat Stategy Rapid-initiation Model of Care: BIC-NOW Clinical Trial (BIC-NOW)
- Registration Number
- NCT06177574
- Lead Sponsor
- Carmen Hidalgo Tenorio
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 208
- HIV-1 infected adults (>17 y.o.)
- Antiretroviral-naïve.
- Be able to comply with protocol requirements and instructions.
- Subject or the subject's representative capable of giving signed informed consent
- Women who are breastfeeding or plan to become pregnant during the study.
- Patients who in the investigator's judgment, poses a significant drop out risk or life expectancy inferior to study ending.
- Patients with anticipated need to change the ART before study ending.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description study group BIC/FTC/TAF 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.
- Primary Outcome Measures
Name Time Method HIV-1 RNA in plasma (week 24) 24 week copies of HIV RNA -1 in plasma at week 24
HIV-1 RNA in plasma week 48 48 week copies of HIV RNA -1 in plasma at week 48
- Secondary Outcome Measures
Name Time Method Retention in care 48 week Subjects completing all study visits
Quality of Life patient reported outcomes EQ-5D 48 week 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)
viral resistance 48 week Incidence of treatment-emergent genotypic or/and phenotypic resistence to any ART
Feasibility of test and treat strategy 48 week 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
Medicaction adherence 48 week proportion of pills taken, self-reported
antiviral activity 48 week Time to viral suppression and absolute changes from baseline in lymphocyte count at week 48
demographics and baseline characteristics 48 week 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
Quality of Life patient reported outcomes dichotomized HIV-Symptoms Index 48 week 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
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] 48 week Incidence and severity of adverse events and laboratory abnormalities
Trial Locations
- Locations (15)
H JEREZ
🇪🇸Jerez De La Frontera, Cádiz, Spain
Hospital Campus de la Salud
🇪🇸Granada, Spain
Complejo Hospitalario de Jaén,
🇪🇸Jaén, Spain
Hospital Clínico Universitario de Valencia
🇪🇸Valencia, Spain
HU la Fé
🇪🇸Valencia, Spain
Hospital Universitario Virgen de Las Nieves
🇪🇸Granada, Andalucía, Spain
Hospital Universitario Puerto Real, INIBICA,
🇪🇸Cadiz, Spain
Hospital Clínico San Carlos, Complutense University, CIBERINFEC ISCIII, Madrid, Spain
🇪🇸Madrid, Spain
Hospital de Son Llàtzer
🇪🇸Palma De Mallorca, Spain
Hospital Universitario Virgen de la Arrixaca, IMIB,
🇪🇸Murcia, Spain
Hospital Universitario Torrecárdenas
🇪🇸Almería, Spain
Ramon Y Cajal
🇪🇸Madrid, Spain
Hu La Princesa
🇪🇸Madrid, Spain
Hospital General Universitario Santa Lucía
🇪🇸Murcia, Spain
Hu Infanta Leonor
🇪🇸Madrid, Spain