Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2025-12-25 @ 3:00 AM
NCT ID:
NCT07004933
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07004933
Study Brief:
Protocol Section:
NCT07004933