HIV Positive People Who Inject DrugsBFTAFDUNCT07004933
Rapid Antiretroviral Treatment Initiation With BIC/FTC/TAF in HIV-infected People Who Inject Drugs (PWID)
An observational study of HIV Positive People Who Inject Drugs, run by Hellenic Scientific Society for the Study of AIDS, Sexually Transmitted and Emerging Diseases at 3 sites in Greece.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Positive People Who Inject Drugs
- What is being tested?
- bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF)
- How many people
- 37 participants
- Where
- 3 sitesGreece
- Study dates
- 22 Dec 2021to 9 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
Greece3 sites
General Hospital of Athens "EVAGGELISMOS"
Athens, Attica, 10676
General Hospital of Athens "LAIKO"
Athens, Attica, 11527
University General Hospital "ATTIKON"
Athens, Attica, 12462
About this study
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
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.
Read the 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.
- Conditions
- HIV Positive People Who Inject Drugs
- Being tested
- bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF)Drug
Rapid antiretroviral treatment initiation with BIC/FTC/TAF
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of subjects with a viral load of <50 copies/ml
The measurement is performed at Week 24 according to FDA snapshot analysis
Measured: 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
Measured: From baseline until Week 24 after treatment initiation
Secondary outcomes (17)
The percentage of subjects with viral load <50 copies/ml at Week 48
The measurement is performed after Week 24 according to FDA snapshot analysis
Measured: At Week 48 after treatment initiation
The percentage of subjects with viral load <50 copies/ml other time points
The measurements are performed in several time points after treatment initiation
Measured: 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
The difference in the percentage of subjects with a viral load of <50 copies/ml will be compared to a historic matched control group
Measured: At Week 24 and 48 after treatment initiation
The percentage of subjects experiencing a grade 3-4 adverse event after Week 24
The record of adverse events (related or not related to study treatment) grade 3 or 4 after Week 24
Measured: From Week 24 to Week 48 after treatment initiation
The mean change of CD4 count, CD4 (%) and CD4/CD8 ratio
The evaluation of the change of CD4 count, CD4 (%) and CD4/CD8 ratio from treatment initiation to Week 48
Measured: From baseline to Week 48 after treatment initiation
The percentage of subjects retained in care at Weeks 24 and 48
The percentage of subjects that remain in the treatment at Weeks 24 and 48, after treatment initiation
Measured: At Weeks 24 and 48, after treatment initiation
The percentage of subjects lost to follow-up
The percentage of subjects that did not remain in the study until Week 48
Measured: From treatment initiation to Week 48
The percentage of subjects with linkage and retention in OST programs
The monitoring of subjects that remained in the OST care until completion of Week 48, after treatment initiation.
Measured: At Weeks 12, 24, and 48
The percentage of adherent patients during the study
Self-assessed adherence to study treatment at several time points during the study by using SMAQ questionnaire
Measured: At Weeks 4, 12, 24, 36, and 48
The percentage of subjects with protocol-defined virologic failure at Week 12 and 24
The percentage of subjects with protocol-defined virologic failure i.e., plasma HIV-RNA >400 copies/ml at Week 12 confirmed on a second sample drawn 15-21 days later or 2 consecutive plasma HIV-RNA >50 copies/ml within 15-21days as of Week 24 at Week 12 and 24
Measured: At Weeks 12 and 24, after treatment initiation
The percentage of subjects requiring discontinuation/modification of treatment
The percentage of subjects requiring discontinuation/modification of treatment with BIC/FTC/TAF throughout the study up to Week 48 due to: (i) Baseline resistance to one of the study drugs, and (ii) Adverse events.
Measured: From baseline to Week 48, after treatment initiation
The percentage of subjects harbouring a virus developing resistance
The percentage of subjects harbouring a virus developing resistance associated mutations at the time of protocol-defined virological failure until Week 48
Measured: From the point of virological failure to Week 48
The percentage of subjects accepting initiation of ART and remaining in the study to Week 48
The percentage of subjects 1) accepting initiation of ART within 7 days from first clinic visit through standard interview (according to EACS guidelines) and 2) accepting initiation of ART within 7 days from first clinic visit through standard interview (according to EACS guidelines) and remaining adherent to ART at Week 4, Week 12, Week 24, and Week 48.
Measured: From treatment initiation to Week 48
The number and type of concomitant medications
The number and type of concomitantly received medications from Day 0 and up to Week 48.
Measured: From Day 0 to Week 48
Changes in the scores of EuroQol Group 5-Dimension 3-Level (EQ-5D-3L) questionnaire
The change in PRO scores EuroQol Group 5-Dimension 3-Level (EQ-5D-3L) from baseline at Weeks 4, 12, 24, 36, and 48. This evaluate the quality of life for several activities like mobility, self care etc. There is a scale from 0 to 100, 0 is for the worst health and 100 is for the best health.
Measured: From baseline to Week 48
Changes in the scores of HIV- Symptom Index (HIV-SI) questionnaire
The HIV Symptom Index (HIV-SI) is a concise, validated questionnaire developed to assess overall symptom distress in people living with HIV, as well as to capture clinically relevant symptom clusters associated with the condition. Patient symptom distress is quantified by evaluating changes in Patient-Reported Outcome (PRO) scores derived from the HIV-SI, enabling effective monitoring of symptom burden over time.
Measured: From baseline to Week 48
Changes in the scores of Treatment Satisfaction Questionnaire for Medication (TSQM)
The change in PRO scores in TSQM relative to Week 4 at Weeks 12, 24, 36, and 48. This questionnaire evaluates the level of satisfaction or dissatisfaction with the medication that a patient is taking during the clinical study. The scale is from 1 to 7, from extremely dissatisfied to extremely satisfied, respectively.
Measured: From baseline to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start22 Dec 2021
- Primary completion9 Dec 2024
- Study completion9 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV Positive People Who Inject DrugsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Scientific Society for the Study of AIDS, Sexually Transmitted and Emerging Diseases
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Mina Psichogiou, Professor, Principal investigator, General Hospital of Athens "LAIKO"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004933
- Sponsor's protocol ID
- BFTAFDU-1
- Acronym
- BFTAFDU
- Status last verified
- Jun 2025
- First submitted
- 5 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision is depending on the scope that the data will be asked - in case of an interested project, the request will be evaluated
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07004933
- Acronym / sponsor ID
- BFTAFDU / BFTAFDU-1
- Conditions
- HIV Positive People Who Inject Drugs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Hellenic Scientific Society for the Study of AIDS, Sexually Transmitted and Emerging DiseasesUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 22 Dec 2021 (actual)
- Primary completion
- 9 Dec 2024 (actual)
- Study completion
- 9 Dec 2024 (actual)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newly diagnosed- and re-linking to care previously- diagnosed HIV-positive subjects | – | Drug: bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF)Rapid antiretroviral treatment initiation with BIC/FTC/TAF | Drug | Newly diagnosed- and re-linking to care previously- diagnosed HIV-positive subjects |
Primary outcome
The percentage of subjects with a viral load of <50 copies/ml
Time frame: Week 24 after treatment initiation
The measurement is performed at Week 24 according to FDA snapshot analysis
The percentage of subjects experiencing a grade 3 or 4 adverse event
Time frame: From baseline until Week 24 after treatment initiation
The record of adverse events (related or not related to study treatment) grade 3 or 4
17 secondary outcomes
The percentage of subjects with viral load <50 copies/ml at Week 48
Time frame: At Week 48 after treatment initiation
The percentage of subjects with viral load <50 copies/ml other time points
Time frame: 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
Time frame: At Week 24 and 48 after treatment initiation
The percentage of subjects experiencing a grade 3-4 adverse event after Week 24
Time frame: From Week 24 to Week 48 after treatment initiation
The mean change of CD4 count, CD4 (%) and CD4/CD8 ratio
Time frame: From baseline to Week 48 after treatment initiation
The percentage of subjects retained in care at Weeks 24 and 48
Time frame: At Weeks 24 and 48, after treatment initiation
The percentage of subjects lost to follow-up
Time frame: From treatment initiation to Week 48
The percentage of subjects with linkage and retention in OST programs
Time frame: At Weeks 12, 24, and 48
The percentage of adherent patients during the study
Time frame: At Weeks 4, 12, 24, 36, and 48
The percentage of subjects with protocol-defined virologic failure at Week 12 and 24
Time frame: At Weeks 12 and 24, after treatment initiation
The percentage of subjects requiring discontinuation/modification of treatment
Time frame: From baseline to Week 48, after treatment initiation
The percentage of subjects harbouring a virus developing resistance
Time frame: From the point of virological failure to Week 48
The percentage of subjects accepting initiation of ART and remaining in the study to Week 48
Time frame: From treatment initiation to Week 48
The number and type of concomitant medications
Time frame: From Day 0 to Week 48
Changes in the scores of EuroQol Group 5-Dimension 3-Level (EQ-5D-3L) questionnaire
Time frame: From baseline to Week 48
Changes in the scores of HIV- Symptom Index (HIV-SI) questionnaire
Time frame: From baseline to Week 48
Changes in the scores of Treatment Satisfaction Questionnaire for Medication (TSQM)
Time frame: From baseline to Week 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: Undecided. The decision is depending on the scope that the data will be asked - in case of an interested project, the request will be evaluated
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mina Psichogiou, Professor principal investigator
General Hospital of Athens "LAIKO"
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Positive People Who Inject Drugs, run by Hellenic Scientific Society for the Study of AIDS, Sexually Transmitted and Emerging Diseases at 3 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of subjects with a viral load of <50 copies/ml (time frame: Week 24 after treatment initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.