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 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT05526118
Eligibility Criteria:
Inclusion Criteria:
* ART-naive adults,18 years of age and older
* diagnosed with HIV within 7 days of study entry
* diagnosis of Advanced HIV: clinical (diagnosed Opportunistic Infection/AIDS-defining illness) or laboratory (CD4\<200) diagnosis of advanced HIV.
Exclusion Criteria:
* Known severe renal impairment (CrCl \<30 mL/min/1.73 m2);
* Known or suspected severe hepatic impairment or unstable liver disease (Child Pugh Class C);
* Use of rifamycins for treatment of OIs
* use of concomitant medications that would be contraindicated for coadministration with Biktarvy;
* OI diagnosis requiring initiation of OI treatment for \>7 days prior to initiation of ART.
* pregnant at time of diagnosis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT05526118
Study Brief:
Protocol Section:
NCT05526118