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:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT05405751
Eligibility Criteria:
Inclusion Criteria:
* Vulnerable person ≥18 years
* Understand and sign the informed consent form
* Confirmed HIV infection
* Not receiving ART or on ART with a PVL \> copies/ml
Exclusion Criteria:
* Unable to provide contact details
* History of allergy to any of the following drugs: bictegravir, tenofovir alafenamide or emtricitabine
* Taking antiretroviral treatment for less than 1 month
* Pregnancy or breastfeeding at the time of screening or gestational desires during the study period.
* Suspected or diagnosed of active opportinistic disease
* History of severe liver disease (Child- Pugh C) or history of descompensated liver disease (defined as the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices or persistent jaundice)
* History of kidney disease CKP-EPI\< 30ml/min
* Have any condition that, as per investigator criteria, makes the patient not candidate to be included (active disease, social situation, intoxication...)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05405751
Study Brief:
Protocol Section:
NCT05405751