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NCT Number: 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)

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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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitario Virgen de Las Nieves, Granada, Andalusia, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HIV-1 infected adults (>17 y.o.)
  • Antiretroviral-naïve.
  • Be able to comply with protocol requirements and instructions.
  • Subject or the subject's representative capable of giving signed informed consent

Exclusion criteria

  • Women who are breastfeeding or plan to become pregnant during the study.
  • Patients who in the investigator's judgment, poses a significant drop out risk or life expectancy inferior to study ending.
  • Patients with anticipated need to change the ART before study ending.

Treatment and study plan

BIC/FTC/TAF

Drug

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

Primary outcomes

  1. HIV-1 RNA in plasma (week 24)

    Time frame: 24 week

    copies of HIV RNA -1 in plasma at week 24

  2. HIV-1 RNA in plasma week 48

    Time frame: 48 week

    copies of HIV RNA -1 in plasma at week 48

Secondary outcomes

  1. Medicaction adherence

    Time frame: 48 week

    proportion of pills taken, self-reported

  2. Retention in care

    Time frame: 48 week

    Subjects completing all study visits

  3. Quality of Life patient reported outcomes EQ-5D

    Time frame: 48 week

    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)

  4. Quality of Life patient reported outcomes dichotomized HIV-Symptoms Index

    Time frame: 48 week

    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

  5. Feasibility of test and treat strategy

    Time frame: 48 week

    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

  6. demographics and baseline characteristics

    Time frame: 48 week

    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

  7. viral resistance

    Time frame: 48 week

    Incidence of treatment-emergent genotypic or/and phenotypic resistence to any ART

  8. antiviral activity

    Time frame: 48 week

    Time to viral suppression and absolute changes from baseline in lymphocyte count at week 48

  9. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Time frame: 48 week

    Incidence and severity of adverse events and laboratory abnormalities

Sponsors and collaborators

Lead sponsor

Carmen Hidalgo Tenorio

Other

Collaborators

  • Gilead Sciences

Registry information

Acronym: BIC-NOW

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 20, 2023
Registry last updated
Dec 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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