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

NCT07004933 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 37

Last updated 2025-06-04

No results posted yet for this study

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

Interventions

DRUG

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

Rapid antiretroviral treatment initiation with BIC/FTC/TAF

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • Hellenic Scientific Society for the Study of AIDS, Sexually Transmitted and Emerging Diseases

    lead OTHER

Principal Investigators

  • Mina Psichogiou, Professor · General Hospital of Athens "LAIKO"

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-22
Primary Completion
2024-12-09
Completion
2024-12-09

Countries

  • Greece

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07004933 on ClinicalTrials.gov