Clinical Trial Results:
A Test and Treat strategy in Barcelona: A prospective study in new HIV diagnosis.
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Summary
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EudraCT number |
2019-004837-17 |
Trial protocol |
ES |
Global end of trial date |
11 May 2023
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Results information
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Results version number |
v1(current) |
This version publication date |
17 Sep 2025
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First version publication date |
17 Sep 2025
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
Biktarvy_Test&Treat
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04416906 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Fundació Clínic per a la Recerca Biomèdica
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Sponsor organisation address |
Villaroel, 170, Barcelona, Spain,
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Public contact |
Berta Torres, Hospital Clínic, +34 9322754004645, btorres@clinic.cat
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Scientific contact |
Berta Torres, Hospital Clínic, +34 9322754004645, btorres@clinic.cat
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
11 May 2023
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
11 May 2023
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Global end of trial reached? |
Yes
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Global end of trial date |
11 May 2023
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To determine the number of patients with the presence of any criteria that contraindicates the start of any antiretroviral regimen within the first week since the HIV confirmation.
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Protection of trial subjects |
The study follows the Declaration of Helsinki, ICH-GCP, and applicable EU and national regulations. All participants will sign informed consent before any study procedures. The trial uses an authorized medication (Biktarvy®) within its approved indication, and no additional procedures pose more than minimal risk.
Safety is monitored through scheduled visits and adverse event reporting. SAEs and SUSARs will be reported promptly. Data confidentiality is ensured through pseudonymization and GDPR compliance. Only authorized personnel will access source data for monitoring or audits.
No Data Safety Monitoring Board (DSMB) is established due to the low-risk nature of the study. Civil liability insurance is in place to cover any harm related to participation.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
06 Oct 2020
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Spain: 100
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Worldwide total number of subjects |
100
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EEA total number of subjects |
100
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
100
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||
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Pre-assignment
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Screening details |
A total of 118 individuals were screened between October 2020 and May 2022. Of these, 100 were enrolled. Reasons for screening failure included exclusion criteria (e.g. recent PrEP use, suspected opportunistic infections) and participant refusal. | ||||||||||||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||
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Arms
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Arm title
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BIC/FTC/TAF | ||||||||||||||||
Arm description |
Participants in this arm received a once-daily fixed-dose combination of bictegravir (50 mg), emtricitabine (200 mg), and tenofovir alafenamide (25 mg) as first-line antiretroviral therapy. Treatment was initiated within 7 days of HIV-1 diagnosis, without waiting for baseline lab results. | ||||||||||||||||
Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
Biktarvy®
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Investigational medicinal product code |
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Other name |
Bictegravir + Emtricitabine + Tenofovir alafenamide
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
This is a fixed dose combination regimen containing 50 mg of Bictegravir + 200 mg of Emtricitabine + 25 mg of Tenofovir alafenamide.
All the subjects will receive one tablet of Biktarvy® every 24 hours during 48 weeks.
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
BIC/FTC/TAF
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Reporting group description |
Participants in this arm received a once-daily fixed-dose combination of bictegravir (50 mg), emtricitabine (200 mg), and tenofovir alafenamide (25 mg) as first-line antiretroviral therapy. Treatment was initiated within 7 days of HIV-1 diagnosis, without waiting for baseline lab results. | ||
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End point title |
Proportion of participants with at least one condition making any recommended ART regimen other than BIC/FTC/TAF less appropriate for rapid initiation [1] | ||||||
End point description |
This endpoint assesses the feasibility of using BIC/FTC/TAF as a rapid initiation regimen in newly diagnosed HIV-1 individuals. It measures the proportion of participants who, based on baseline laboratory and clinical data, present at least one condition that would make other guideline-recommended ART regimens less suitable for immediate initiation. These conditions include: HLA B*5701 positivity, HBsAg positivity, M184V mutation, HIV RNA >500,000 copies/mL, eGFR <50 mL/min, and concomitant medications with significant drug–drug interactions.
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End point type |
Primary
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End point timeframe |
Week 4 after ART initiation
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint is descriptive and reports the proportion of participants with contraindications to alternative ART regimens. It is summarized with a 95% confidence interval. No formal hypothesis testing was planned, as the aim is to assess feasibility rather than compare treatments. |
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| No statistical analyses for this end point | |||||||
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Adverse events information
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Timeframe for reporting adverse events |
From baseline (week 0) to week 48.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
25.0
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Reporting groups
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Reporting group title |
BIC/FTC/TAF
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Reporting group description |
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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03 Mar 2022 |
Correction of two protocol elements:
Clarification that patients receiving non-permitted medication must be withdrawn from the study (previously referred to as “not recommended medication”).
Removal of the CESTA questionnaire from the baseline visit; it will now only be conducted at week 48. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| The main limitation is the disparity between the protocol and the non-prespecified primary outcomes. Such a significant change indicates evolving standards in HIV treatment, as these findings predominantly align with European and US guidelines. | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/39045754 |
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