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)

Carmen Hidalgo Tenorio208 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

208

Conditions

HIV Infections

Interventions

BIC/FTC/TAFDRUG

TEST and TREAT strategy: Study group will start the intervention at the first visit with their healthcare provider.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. HIV-1 infected adults (\>17 y.o.) 2. Antiretroviral-naïve. 3. Be able to comply with protocol requirements and instructions. 4. Subject or the subject's representative capable of giving signed informed consent Exclusion Criteria: 1. Women who are breastfeeding or plan to become pregnant during the study. 2. Patients who in the investigator's judgment, poses a significant drop out risk or life expectancy inferior to study ending. 3. Patients with anticipated need to change the ART before study ending.

Locations (15)

Hospital Universitario Virgen de Las Nieves

Granada, Andalusia, Spain

H JEREZ

Jerez de la Frontera, Cádiz, Spain

Hospital Universitario Torrecárdenas

Almería, Spain

Outcomes

Primary Outcomes

HIV-1 RNA in plasma (week 24)

copies of HIV RNA -1 in plasma at week 24

Time frame: 24 week

HIV-1 RNA in plasma week 48

copies of HIV RNA -1 in plasma at week 48

Time frame: 48 week

Secondary Outcomes

Medicaction adherence

proportion of pills taken, self-reported

Time frame: 48 week

Retention in care

Subjects completing all study visits

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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