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)

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: BIC/FTC/TAF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>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. | Drug: BIC/FTC/TAF<br>* TEST and TREAT strategy: Study group will start the intervention at the first visit with their healthcare provider.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medicaction adherence | proportion of pills taken, self-reported | 48 week | 
| Retention in care | Subjects completing all study visits | 48 week | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, TEST and TREAT, IMPLEMENTATION