Rapid Antiretroviral Treatment Initiation With BIC/FTC/TAF in HIV-infected People Who Inject Drugs (PWID)

NCT07004933 | Completed DMC

• 1 other identifier: BFTAFDU-1
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this clinical study is to evaluate the effectiveness, safety and patient experience of an integrated care pathway combining rapid antiretroviral (ART) initiation with BIC/FTC/TAF and peer navigation for treatment naïve newly-diagnosed or relinking HIV-infected PWIDs, in terms of viral suppression rates, adverse events and patient-reported health outcomes (PROs). The main objectives of the study are the assessment of:

• The viral suppression rates at 24 weeks after the rapid initiation of ART with BIC/FTC/TAF coupled with secured peer-navigation in adult HIV-positive PWID who are treatment-naïve or re-linking to care
• The safety and tolerability of BIC/FTC/TAF in the specific context of rapid ART initiation in adult PWID who are treatment-naïve or re-linking to care from baseline until Week 24. Patients will receive their medication according to the standard of care and will visit the clinic as usual. No extra visits or extra lab tests will be performed.

Conditions

HIV Positive People Who Inject Drugs

Outcome Measures

Primary Outcomes (2)

• The percentage of subjects with a viral load of <50 copies/ml

  The measurement is performed at Week 24 according to FDA snapshot analysis

  Week 24 after treatment initiation

• The percentage of subjects experiencing a grade 3 or 4 adverse event

  The record of adverse events (related or not related to study treatment) grade 3 or 4

  From baseline until Week 24 after treatment initiation

Secondary Outcomes (17)

• The percentage of subjects with viral load <50 copies/ml at Week 48

  At Week 48 after treatment initiation

• The percentage of subjects with viral load <50 copies/ml other time points

  At Weeks 4, 12, 24, 36, and 48 after treatment initiation

• The difference in the percentage of subjects with a viral load of <50 copies/ml at Weeks 24 and 48

  At Week 24 and 48 after treatment initiation

• The percentage of subjects experiencing a grade 3-4 adverse event after Week 24

  From Week 24 to Week 48 after treatment initiation

• The mean change of CD4 count, CD4 (%) and CD4/CD8 ratio

  From baseline to Week 48 after treatment initiation

Study Arms (1)

Newly diagnosed- and re-linking to care previously- diagnosed HIV-positive subjects

HIV-positive PWID (people who inject drugs) subjects that enroll in the study within 7 days from the first visit in the clinic and are treatment-naïve or have discontinued antiretroviral treatment (ART) for more than 3 months from enrollment.

Drug: bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF)

Interventions

bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF) DRUG

Rapid antiretroviral treatment initiation with BIC/FTC/TAF

Newly diagnosed- and re-linking to care previously- diagnosed HIV-positive subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV-positive PWID subjects that enroll in the study within 7 days from the first visit in the clinic and are treatment-naïve or have discontinued antiretroviral treatment (ART) for more than 3 months from enrollment.

You may qualify if:

• Male or female PWID subjects ≥18 years old
• Documented and confirmed diagnosis of HIV infection
• Naïve to ART or having discontinued ART for more than 3 months and relinking to care without documented resistance to any of the components of BIC/FTC/TAF or having missed more than once during the last 12 months, their monthly appointment for ART prescription renewal.
• Willingness of patients to start OST or already being in OST.
• Subjects willing and able to understand and provide written informed consent prior to participation in the study.
• Females may be eligible for enrolment if they are i) of non-child-bearing potential or ii) if they are of child-bearing potential must have a negative pregnancy test at initial screening and agree to use throughout the study a medically acceptable method of contraception (barrier and/or hormonal method) or iii) are sterilized.

You may not qualify if:

• Centers for Disease Control and Prevention Category C at baseline or presenting with clinical symptoms suggestive of opportunistic infections precluding rapid ART initiation per EACS guidelines 2020.
• Alanine aminotransferase (ALT) \>5 times upper limit normal (ULN) - Subjects with severe hepatic impairment (Child-Pugh score\>9).
• eGFR\<30 ml/min
• Any serious medical condition which would compromise the safety of the subject. Subject has a pre-existing mental, physical, or severe substance abuse disorder that may interfere with the subject's ability to comply with the dosing schedule and protocol evaluations and assessments. Subject has a condition or disorder which may interfere with drug absorption or render the subject unable to take oral medication.
• Subject is, in the opinion of the Investigator, unable to complete the study dosing period and protocol evaluations and assessments. Patients with alcohol and drug use problems that in the view of the Investigator will compromise participation in the study.
• Subject has any acute laboratory abnormality at screening, which, in the opinion of the Investigator, would preclude the subject's participation in the study. Any verified grade 4 abnormality would exclude a subject from participation in the study.
• Subject is receiving or has received within 14 days prior to screening, any drug that has been classified as contraindicated from use with BIC/FTC/TAF
• Pregnant or breast-feeding subjects.
• Participation in another clinical trial.

Sponsors & Collaborators

• Hellenic Scientific Society for the Study of AIDS, Sexually Transmitted and Emerging Diseases: lead
• Gilead Sciences: collaborator

Study Sites (3)

General Hospital of Athens "EVAGGELISMOS"

Athens, Attica, 10676, Greece

Location

General Hospital of Athens "LAIKO"

Athens, Attica, 11527, Greece

Location

University General Hospital "ATTIKON"

Athens, Attica, 12462, Greece

Location

MeSH Terms

Interventions

bictegravir; emtricitabine tenofovir alafenamide

Study Officials

• Mina Psichogiou, Professor

  General Hospital of Athens "LAIKO"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: June 4, 2025
• Study Start: December 22, 2021
• Primary Completion: December 9, 2024
• Study Completion: December 9, 2024
• Last Updated: June 4, 2025

Record last verified: 2025-06

Locations

GR (3)