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 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT03518060
Eligibility Criteria:
Inclusion Criteria:
* Greated than or equal to (\>=)18 years of age.
* Documented HIV-1 infection.
* Virologically suppressed (HIV-1 ribonucleic acid \[RNA\] less than \[\<\] 50 copies \[c\]/mL for at least 6 months)
* Prescription for JULUCA was issued independently from entering this study.
* Ability to understand informed consent form and other relevant study documents
Exclusion Criteria:
* Any contraindication according to JULUCA SmPC.
* Documented viral load greater than (\>) 50 c/mL at any time point within 6 months prior to inclusion into this study.
* History of treatment failure.
* Known or suspected substitutions associated with resistance to any non-nucleoside reverse-transcriptase inhibitors (NNRTI) or integrase strand transfer inhibitor (INSTI).
* Any ART for the treatment of HIV-1 in addition to JULUCA.
* Hepatitis B virus (HBV)-co-infection.
* Current participation in the ongoing non-interventional study TRIUMPH (study number: 202033) or any interventional clinical trial irrespective of indication.
* Previous participation in clinical trials involving JULUCA.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03518060
Study Brief:
Protocol Section:
NCT03518060