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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-27

Study Completion Date

2023-10-30

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.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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study group

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.

Group Type EXPERIMENTAL

BIC/FTC/TAF

Intervention Type DRUG

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

Interventions

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BIC/FTC/TAF

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No