Clinical trial NCT07004933: Rapid Antiretroviral Treatment Initiation With BIC/FTC/TAF in HIV-infected People Who Inject Drugs (PWID)
Official title: Rapid ART Initiation With BIC/FTC/TAF in HIV-infected People Who Inject Drugs (Naive or Re-linking to Care): a Pilot Study of an Integrated Care Model
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Positive People Who Inject Drugs
Lead sponsor: Hellenic Scientific Society for the Study of AIDS, Sexually Transmitted and Emerging Diseases
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2025-06-04
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Detailed description: Taking into account the increased rates of new cases of HIV infection among people who inject drugs (PWID) in Greece, it is proposed the conduct of the observational study with the aim to assess whether clinical outcomes can be improved by the implementation of rapid ART initiation in newly diagnosed HIV-positive PWIDs and re-linking to care previously diagnosed HIV-positive PWIDs with a suitable medication, such as BIC/FTC/TAF, combined with peer-navigation support that can help the afflicted patients overcome social barriers and challenges. Therefore, this pilot study aims to evaluate the effectiveness, safety and patient experience of an integrated care pathway combining rapid 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). Given the armamentarium of potent ART regimens, HIV infection has been transformed from a terminal illness into a chronic condition, thus, evaluating the impact of ARTs from patients' perspective is increasingly used \[17\]. The results of this study are expected to contribute towards informed health policy practices, accelerating and ameliorating care and providing the basis to curb the HIV epidemic and bringing us closer to its end.

Eligibility criteria: Inclusion Criteria:

1. Male or female PWID subjects ≥18 years old
2. Documented and confirmed diagnosis of HIV infection
3. 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.
4. Willingness of patients to start OST or already being in OST.
5. Subjects willing and able to understand and provide written informed consent prior to participation in the study.
6. 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.

Exclusion Criteria:

1. 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.
2. Alanine aminotransferase (ALT) \>5 times upper limit normal (ULN) - Subjects with severe hepatic impairment (Child-Pugh score\>9).
3. eGFR\<30 ml/min
4. 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.
5. 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.
6. 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.
7. 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
8. Pregnant or breast-feeding subjects.
9. Participation in another clinical trial.

Primary outcomes:
measure: The percentage of subjects with a viral load of <50 copies/ml
timeFrame: Week 24 after treatment initiation
measure: The percentage of subjects experiencing a grade 3 or 4 adverse event
timeFrame: From baseline until Week 24 after treatment initiation
Secondary outcomes:
measure: The percentage of subjects with viral load <50 copies/ml at Week 48
timeFrame: At Week 48 after treatment initiation
measure: The percentage of subjects with viral load <50 copies/ml other time points
timeFrame: At Weeks 4, 12, 24, 36, and 48 after treatment initiation
measure: The difference in the percentage of subjects with a viral load of <50 copies/ml at Weeks 24 and 48
timeFrame: At Week 24 and 48 after treatment initiation
measure: The percentage of subjects experiencing a grade 3-4 adverse event after Week 24
timeFrame: From Week 24 to Week 48 after treatment initiation
measure: The mean change of CD4 count, CD4 (%) and CD4/CD8 ratio
timeFrame: From baseline to Week 48 after treatment initiation
measure: The percentage of subjects retained in care at Weeks 24 and 48
timeFrame: At Weeks 24 and 48, after treatment initiation
measure: The percentage of subjects lost to follow-up
timeFrame: From treatment initiation to Week 48
measure: The percentage of subjects with linkage and retention in OST programs
timeFrame: At Weeks 12, 24, and 48
measure: The percentage of adherent patients during the study
timeFrame: At Weeks 4, 12, 24, 36, and 48
measure: The percentage of subjects with protocol-defined virologic failure at Week 12 and 24
timeFrame: At Weeks 12 and 24, after treatment initiation
measure: The percentage of subjects requiring discontinuation/modification of treatment
timeFrame: From baseline to Week 48, after treatment initiation
measure: The percentage of subjects harbouring a virus developing resistance
timeFrame: From the point of virological failure to Week 48
measure: The percentage of subjects accepting initiation of ART and remaining in the study to Week 48
timeFrame: From treatment initiation to Week 48
measure: The number and type of concomitant medications
timeFrame: From Day 0 to Week 48
measure: Changes in the scores of EuroQol Group 5-Dimension 3-Level (EQ-5D-3L) questionnaire
timeFrame: From baseline to Week 48
measure: Changes in the scores of HIV- Symptom Index (HIV-SI) questionnaire
timeFrame: From baseline to Week 48
measure: Changes in the scores of Treatment Satisfaction Questionnaire for Medication (TSQM)
timeFrame: From baseline to Week 48
Other outcomes:
Locations:
city: Athens
country: Greece
facility: General Hospital of Athens "EVAGGELISMOS"
state: Attiki
city: Athens
country: Greece
facility: General Hospital of Athens "LAIKO"
state: Attiki
city: Athens
country: Greece
facility: University General Hospital "ATTIKON"
state: Attiki
Study officials:
affiliation: General Hospital of Athens "LAIKO"
name: Mina Psichogiou, Professor
role: PRINCIPAL_INVESTIGATOR
References: