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)
Overview
- Phase
- Phase 4
- Intervention
- BIC/FTC/TAF
- Conditions
- HIV Infections
- Sponsor
- Carmen Hidalgo Tenorio
- Enrollment
- 208
- Locations
- 15
- Primary Endpoint
- HIV-1 RNA in plasma (week 24)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Carmen Hidalgo Tenorio
Principal Investigator, Medical Director of the Early Stage Clinical Trial Unit-IBS.Granada
University Hospital Virgen de las Nieves
Eligibility Criteria
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.
Arms & Interventions
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.
Intervention: BIC/FTC/TAF
Outcomes
Primary Outcomes
HIV-1 RNA in plasma (week 24)
Time Frame: 24 week
copies of HIV RNA -1 in plasma at week 24
HIV-1 RNA in plasma week 48
Time Frame: 48 week
copies of HIV RNA -1 in plasma at week 48
Secondary Outcomes
- Retention in care(48 week)
- Quality of Life patient reported outcomes EQ-5D(48 week)
- viral resistance(48 week)
- Feasibility of test and treat strategy(48 week)
- Medicaction adherence(48 week)
- antiviral activity(48 week)
- demographics and baseline characteristics(48 week)
- Quality of Life patient reported outcomes dichotomized HIV-Symptoms Index(48 week)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](48 week)