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)

HIV Infections 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06177574
• Other study ID #: BIC-NOW
• Status: Completed
• Phase: Phase 4
• Start date: October 27, 2020
• Est. completion date: October 30, 2023

Study information

• Verified date: December 2023
• Source: University Hospital Virgen de las Nieves
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• BIC/FTC/TAF
TEST and TREAT strategy: Study group will start the intervention at the first visit with their healthcare provider.

Locations

Country	Name	City	State
Spain	Hospital Universitario Torrecárdenas	Almería
Spain	Hospital Universitario Puerto Real, INIBICA,	Cadiz
Spain	Hospital Campus de la Salud	Granada
Spain	Hospital Universitario Virgen de Las Nieves	Granada	Andalucía
Spain	Complejo Hospitalario de Jaén,	Jaén
Spain	H JEREZ	Jerez De La Frontera	Cádiz
Spain	Hospital Clínico San Carlos, Complutense University, CIBERINFEC ISCIII, Madrid, Spain	Madrid
Spain	Hu Infanta Leonor	Madrid
Spain	Hu La Princesa	Madrid
Spain	Ramon Y Cajal	Madrid
Spain	Hospital General Universitario Santa Lucía	Murcia
Spain	Hospital Universitario Virgen de la Arrixaca, IMIB,	Murcia
Spain	Hospital de Son Llàtzer	Palma De Mallorca
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	HU la Fé	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Carmen Hidalgo Tenorio	Gilead Sciences

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV-1 RNA in plasma (week 24)	copies of HIV RNA -1 in plasma at week 24	24 week
Primary	HIV-1 RNA in plasma week 48	copies of HIV RNA -1 in plasma at week 48	48 week
Secondary	Medicaction adherence	proportion of pills taken, self-reported	48 week
Secondary	Retention in care	Subjects completing all study visits	48 week
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	viral resistance	Incidence of treatment-emergent genotypic or/and phenotypic resistence to any ART	48 week
Secondary	antiviral activity	Time to viral suppression and absolute changes from baseline in lymphocyte count at week 48	48 week
Secondary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Incidence and severity of adverse events and laboratory abnormalities	48 week