Clinical trial NCT06177574: 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)
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Keywords: HIV
TEST and TREAT
IMPLEMENTATION
Lead sponsor: University Hospital Virgen de las Nieves
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2023-12-20
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: HIV-1 RNA in plasma (week 24)
timeFrame: 24 week
measure: HIV-1 RNA in plasma week 48
timeFrame: 48 week
Secondary outcomes:
measure: Medicaction adherence
timeFrame: 48 week
measure: Retention in care
timeFrame: 48 week
measure: Quality of Life patient reported outcomes EQ-5D
timeFrame: 48 week
measure: Quality of Life patient reported outcomes dichotomized HIV-Symptoms Index
timeFrame: 48 week
measure: Feasibility of test and treat strategy
timeFrame: 48 week
measure: demographics and baseline characteristics
timeFrame: 48 week
measure: viral resistance
timeFrame: 48 week
measure: antiviral activity
timeFrame: 48 week
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: 48 week
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Hospital Universitario Virgen de Las Nieves
state: Andalucía
city: Jerez De La Frontera
country: Spain
facility: H JEREZ
state: Cádiz
city: Almería
country: Spain
facility: Hospital Universitario Torrecárdenas
city: Cadiz
country: Spain
facility: Hospital Universitario Puerto Real, INIBICA,
city: Granada
country: Spain
facility: Hospital Campus de la Salud
city: Jaén
country: Spain
facility: Complejo Hospitalario de Jaén,
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos, Complutense University, CIBERINFEC ISCIII, Madrid, Spain
city: Madrid
country: Spain
facility: Hu Infanta Leonor
city: Madrid
country: Spain
facility: Hu La Princesa
city: Madrid
country: Spain
facility: Ramon Y Cajal
city: Murcia
country: Spain
facility: Hospital General Universitario Santa Lucía
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca, IMIB,
city: Palma De Mallorca
country: Spain
facility: Hospital de Son Llàtzer
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: HU la Fé
Study officials:
References: