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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06177574
Other study ID # BIC-NOW
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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