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 @ 11:52 PM
Ignite Modification Date:
2025-12-24 @ 11:52 PM
NCT ID:
NCT04334551
Eligibility Criteria:
Inclusion Criteria:
\- Adult (18 Y.O. or more) women and men infected with HIV.
* Treated with etravirine and at least 2 others ARV in the other classes: NRTI, PI, INSTI, EI, for at least 12 months.
* Virologically controlled (HIV-1 RNA \< 50 copies/mL) since at least 6 months. Blips (HIV-ARN ≥ 50 copies/mL, one time, with return to virologic control at the next visit) are allowed.
* Presence of at least one major NNRTI mutation.
* No limitation on the number of previous regimens.
* HCV and HBV-infected patients are allowed
Exclusion Criteria:
High level of resistance to doravirine according to historical resistance tests.
* Level of resistance to doravirine superior to that of etravirine
* Opportunistic or serious active infection or disease
* Active and untreated malignancy.
* Current psychiatric or neurocognitive condition judged by the Investigator to potentially interfere with study visits and procedures
* Pregnancy.
* Active treatment for hepatitis C is forbidden at entry but will be allowed after 3
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT04334551
Study Brief:
Protocol Section:
NCT04334551