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) (BIC-NOW)

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 Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: BIC/FTC/TAF

• Study Type: Interventional
• Enrollment (Actual): 208
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Almería, Spain
    • Hospital Universitario Torrecárdenas
  • Cadiz, Spain
    • Hospital Universitario Puerto Real, INIBICA,
  • Granada, Spain, 18014
    • Hospital Campus de la Salud
  • Jaén, Spain
    • Complejo Hospitalario de Jaén,
  • Madrid, Spain
    • Ramon Y Cajal
  • Madrid, Spain
    • Hospital Clínico San Carlos, Complutense University, CIBERINFEC ISCIII, Madrid, Spain
  • Madrid, Spain
    • Hu Infanta Leonor
  • Madrid, Spain
    • Hu La Princesa
  • Murcia, Spain
    • Hospital General Universitario Santa Lucia
  • Murcia, Spain
    • Hospital Universitario Virgen de la Arrixaca, IMIB,
  • Palma De Mallorca, Spain
    • Hospital de Son Llàtzer
  • Valencia, Spain
    • Hospital Clínico Universitario de Valencia
  • Valencia, Spain
    • HU la Fé
  • Andalucía
    • Granada, Andalucía, Spain, 18008
      • Hospital Universitario Virgen de las Nieves
  • Cádiz
    • Jerez De La Frontera, Cádiz, Spain
      • H JEREZ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: BIC/FTC/TAF; TEST and TREAT strategy: Study group will start the intervention at the first visit with their healthcare provider.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Carmen Hidalgo Tenorio
• Collaborators: Gilead Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2020
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: December 18, 2023
• First Posted (Actual): December 20, 2023

Study Record Updates

• Last Update Posted (Actual): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: HIV; TEST and TREAT; IMPLEMENTATION
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Urogenital Diseases; Genital Diseases; HIV Infections
• Other Study ID Numbers: BIC-NOW

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No